Infections

All Conditions

Symptoms and General Pathology

Rare Diseases

Communicable Diseases

Cytomegalovirus Infections

Epstein-Barr Virus Infections

Virus Diseases

Adenoviridae Infections

Disease Attributes

DNA Virus Infections

Herpesviridae Infections

Tumor Virus Infections

Cytomegalic Inclusion Disease

Subjects will receive Multivirus specific T cells on one of the following dose levels:

Level One: 5 x 10\^6 rCTLs/m2

Level Two: 1 x 10\^7 rCTLs/m2

Level Three: 2 x 10\^7 rCTLs/m2

Level Four: 5 x 10\^7 rCTLs/m2

If a patient has a partial response (as defined by a 50% fall in viral load) or receives medication (such as steroids) which may affect the persistence or function of the infused CTL they are eligible to receive up to 2 additional doses at the same initial dose. The minimum time between additional doses is 28 days.

Multi-virus Specific T cells

Helen E Heslop, MD

Patient's on this protocol have a type of blood cell cancer, other blood disease or a genetic disease and have received a stem cell transplant. The donor of the stem cells was either a brother or sister, another relative, or a closely matched unrelated donor. The patient is being asked to participate in this study which tests if blood cells from the donor that have been grown in a special way, can prevent or be an effective treatment for early infection by three viruses - Epstein Barr virus (EBV), cytomegalovirus (CMV) and adenovirus.

Adenovirus is a virus that usually causes symptoms of a common cold, but can cause serious life-threatening infections in patients who have weak immune systems. It can affect the lungs and cause very serious pneumonia, and can also damage the gut, liver, pancreas and eyes.CMV can also cause serious infections in patients with weak or suppressed immune systems. It usually affects the lungs, causing a very serious pneumonia, but it can also affect the gut, the liver and the eyes. Approximately 2/3 of normal people harbor this virus in their body. In healthy people CMV rarely causes any problems because the immune system can keep it under control, but after a transplant, the risk of developing CMV disease is much higher because the immune system is so weak. EBV is the virus that causes glandular fever. It is also a life long infection like CMV that is normally controlled by the immune system. When immunity is weak, the virus can become active and cause fevers, enlarged lymph nodes and sometimes a type of cancer called lymphoma.

Investigators want to see if a kind of white blood cell called T lymphocytes (T cells)can be used to prevent and treat adenovirus, CMV and EBV in the early stages of reactivation or infection. T cells have been grown from the patient's stem cell donor in the laboratory in a way that will train them to recognize the virus and control it when they are given after a transplant. This treatment with specially trained T cells (also called CTLs) has had activity against these viruses in previous studies and in this study investigators want to see if they still have activity when they are made in a simpler and faster way. These donor-derived multivirus-specific special cell lines are an investigational product not approved by the Food and Drug Administration.

The purpose of this study is to evaluate whether donor-derived multivirus-specific special cell lines are safe and can control three viruses: EBV, CMV and adenovirus.

Blood has been previously taken from the patient and the donor to make the cells.

To make the special cell line, special blood cells called dendritic cells (DCs)were made first from the donor blood. Then, a specially produced gene called a plasmid that carries the adenovirus, CMV, and EBV genes was introduced into the dendritic cells. Dendritic cells with these new genes are then mixed with T cells to stimulate them. This stimulation trains the donor T cells to kill cells that are infected with CMV, EBV, and adenovirus. Once a sufficient numbers of T cells were made, they were tested to make sure they killed the patient's cells infected with these viruses, but not the patient's normal cells, and were frozen.

If the donor has never been infected with CMV, the CTLs made for the patient may not have activity against a CMV infection. If these donor CTLs show no activity against CMV infection, the cells will not be given.

The patient may receive Benadryl (diphenhydramine) and Tylenol (acetaminophen). Then, the donor's special cells will be thawed and injected into the patient's intravenous line. After the patient receives the cells, the levels of these three viruses in the patient's blood will be monitored. Investigators will also take blood to see how long the T cells given to the patient are lasting in the patient's body.

If the special cell infusion has helped the infection or if the patient has had a treatment (for example with steroid drugs) that might have destroyed the T cells that were given to them, then the patient is allowed to receive up to 2 more doses of the cells.

The patient will continue to be followed by his/her transplant doctors after the injection. The patient will either be seen in the clinic or contacted by a research nurse to follow up for this study every week for 6 weeks then at 8 weeks, and 3, 6, and 12 months. The patient may have other visits for standard care.

The patient will also have regular blood tests done to follow counts and the viral infection. To learn more about the way the T cells are working in the patient's body, up to an extra 30-40 ml (6-8 teaspoons) of blood will be taken before the infusion and then at 1, 2, 4, 6, and 8 weeks and 3 months. Blood should come from the central intravenous line, and should not require extra needle sticks. Total time participation for this study will be 1 year.

Administration of Rapidly Generated Multivirus-specific Cytotoxic T-Lymphocytes (VIRAGE)

Administration of Rapidly Generated Multivirus-specific Cytotoxic T-Lymphocytes for the Prophylaxis and Treatment of EBV, CMV, and Adenovirus Infection Post Allogeneic Stem Cell Transplant (VIRAGE)

Safety and toxicity outcomes including DLTs, GvHD, clinical signs of viral infections, secondary graft failure and laboratory measurements will be summarized using descriptive statistics for each dose level (frequency table, means, standard deviations, medians and ranges).

Primary endpoint for the phase II portion of the study is antiviral efficacy, and is whether the institution of additional antiviral therapy post rCTL is needed.

The Methodist Hospital Research Institute

Center for Cell and Gene Therapy, Baylor College of Medicine

Baylor College of Medicine

Professor of Pediatrics-Hem-Onc Cell & Gene

Neoplasms

Rhabdomyosarcoma

Myosarcoma

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Sarcoma

Soft Tissue Sarcoma

Antipyretics

Analgesics

All Drugs and Chemicals

Anti-Allergic Agents

Antiemetics

Central Nervous System Depressants

Gastrointestinal Agents

Dermatologic Agents

Acetaminophen

Diphenhydramine

Promethazine

4 different dosing schedules will be evaluated. 2 to 4 patients will be evaluated on each dosing schedule. The first 2 patients on each dose level will be staggered by 4 weeks (which starts when the first infusion is given, Day 0). No subjects between the ages of 2-18 will be enrolled to a dose level on this protocol, until an adult has been enrolled to and treated on that dose level on one of the protocols being conducted under this same IND. Each patient will receive 2 injections at the same dose,14 days apart: The expected volume of infusion will be 1 to 10 cc.

Dose Level One:

Day 0 and 14: 5 x 10\^6 cells/m\^2

Dose Level Two:

Day 0 and 14: 1 x 10\^7 cells/m\^2

Dose Level Three:

Day 0 and 14: 2 x 10\^7 cells/m\^2

Dose Level Four:

Day 0 and 14: 4 x 10\^7 cells/m\^2

Patients may be pre-medicated with Benadryl up to 1 mg/kg IV (max 50 mg) and Tylenol 10 mg/kg po (max 650 mg).

Cell Administration: Tumor-specific T cells will be given by intravenous injection over 1-10 minutes through either a peripheral or a central line.

Patients with stable disease or better will receive up to 6 further doses of CTLs, as long as they continue to show disease stabilization or improvement by RECIST criteria at their 8 week or subsequent evaluations. Each dose will consist of the same number as their second injection or less (if there is not enough product available for the subject's original dose).

Patients will not be able to receive additional doses until the initial safety profile is completed at 6 weeks following the second infusion.

TAA-Specific CTLs

Ann Leen, PhD

Cliona Rooney, PhD

Helen Heslop, MD

Sarah Whittle, MD

This is a clinical trial for patients with a solid tumor which has come back, or may come back, or has not gone away after treatment, including the standard treatment we know for these diseases. This is a study using special immune system cells called tumor-associated antigen (TAA)-specific cytotoxic T lymphocytes, a new experimental therapy.

The proteins that the investigators are targeting in this study are called tumor-associated antigens (TAAs). These are cell proteins that are specific to the cancer cell, so they either do not show or show up in low quantities on normal human cells. In this study, the investigators target five common TAAs called NY-ESO-1, MAGEA4, PRAME, Survivin and SSX. On a different study, patients have been treated and so far this treatment has shown to be safe.

The investigators now want to try this treatment in patients with solid tumors.

This protocol is designed as a Phase I dose-escalation study.

Blood will be collected from the patient and TAA-specific CTLs will be made.

The cells will be injected by IV into the patient over 1 - 10 minutes. The patient may be pre-treated with acetaminophen (Tylenol) and diphenhydramine (Benadryl). Acetaminophen (Tylenol) and diphenhydramine (Benadryl) are given to prevent a possible allergic reaction to the T cell infusion. Initially, two doses of T cells will be given two weeks apart. The patient's disease will be assessed pre-infusion and then 6 weeks after the second infusion. If after the second infusion, there is a reduction in size of the patient's tumor or if the tumor remains stable on CT or MRI scan as assessed by a radiologist, the patient can receive up to six (6) additional doses of the T cells at monthly intervals. All of the treatments will be given by the Center for Cell and Gene Therapy at Houston Methodist Hospital or Texas Children's Hospital.

In between the first and second T cell infusions, and for 6 weeks after the last infusion, the investigators ask that the patient not receive any other anti-cancer treatments, such as radiation therapy or chemotherapy, except PD1/PDL1 inhibitors as clinically indicated. If the patient does receive any other therapies in-between the first and second infusion of T cells, they will be taken off treatment and will not be able to receive the second infusion of T cells.

This is a dose escalation study. This means that at the beginning, patients will be started on the lowest dose (1 of 4 different levels) of T cells. Once that dose schedule proves safe, the next group of patients will be started at a higher dose. This process will continue until all 4 dose levels are studied. If the side effects are too severe, the dose will be lowered or the T cell injections will be stopped.

MEDICAL TESTS BEFORE TREATMENT:

Before being treated, patients will receive a series of standard medical tests:

* Physical exam.
* Blood tests to measure blood cells, kidney and liver function.
* Measurements of the patient's tumor by routine imaging studies. The investigators will use the imaging study that was previously performed to follow the patient's tumor: Computer Tomogram (CT), Magnetic Resonance Imaging (MRI), or Positron Emission Tomography (PET).
* Pregnancy test if the patient is a female who can have children.

MEDICAL TEST AFTER TREATMENT:

Patients will receive standard medical test after infusion:

* Patients will receive standard medical test after infusion:
* Blood tests to measure blood cells, kidney and liver function.
* Imaging study 6 weeks after the 2nd CTL infusion.

To learn more about the way the T cells are working in the patient's body, an extra 20-40 mL (4-8 teaspoons) of blood will be taken before each infusion, and at Weeks 1, 2, 4 and 6. Afterwards, blood will be collected at 3, 6, 9 and 12 months after the last infusion. The investigators will use this blood to see how long the T cells last, and to look at the immune response to the patient's response to cancer. Patients will then be contacted once a year for up to 4 additional years (total of 5 years follow-up) to evaluate their disease response long-term.

Study Duration: The patient's active participation in this study will last for approximately one (1) year. If the patient receives additional doses of the TAA-CTLs as described above, then the patient's active participation will last until one (1) year after his/her last dose. We will then contact the patient once a year for up to 4 additional years (total of 5 years follow-up) in order to evaluate his/her disease response long-term.

TAA-Specific CTLS for Solid Tumors (TACTASOM)

Tumor Associated Antigen (TAA)-Specific Cytotoxic T-Lymphocytes Administered to Patients With Solid Tumors

The Phase I dose escalation trial is designed for the primary goal of evaluating the safety and feasibility of administering TAA-CTLs to patients with solid tumors.

Solving Kids' Cancer

Pierce Phillips Charity

Assistant Professor, Pediatric Hematology/Oncology, Center for Cell and Gene Therapy

Recurrence

Death

Head and Neck Neoplasms

Neoplasm Metastasis

Neoplastic Cells, Circulating

Tsang-Tang Hsieh, M.D

Chia-Hsun Hsieh, M.D,M.S.

Chia-Hsun Hsieh, M.D., M.S

Min-Hsien Wu, PhD.

Hung-Ming Wang, M.D.

Siang-Fu Huang, M.D.,PhD.

Yonɡ-Chanɡ Lin, M.D.

Chia-Hsun Hsieh, M.D, M.S.

Head and neck squamous cell carcinomas (HNSCCs) are mainly caused by tobacco, alcohol consumption and betel nut chewing and the sixth most common cancer in the world. Despite significant advances in the treatment modalities involving surgery, radiotherapy, and concomitant chemoradiotherapy, the 5-year survival rate remained below 50% for the past 30 years.

The worse prognosis of these cancers must certainly be linked to the fact that HNSCCs strongly influence the host immune system. During this process, mesenchymal tumor-like cells are highly mobile and enter quickly adjacent structure (intravasation), from where they travel through lymphatic and blood vessels as circulating tumor cells (CTC), which are single cells with malignant potential detected in the peripheral bloodstream and essential for establishing metastasis.

Programmed death 1 (PD-1) and its ligand (PD-L1) play pivotal roles in regulating host immune responses. Substantial evidence has demonstrated that PD-L1 can deliver an inhibitory signal to PD-1 expressing T cells, leading to suppression of the immune response by inducing apoptosis, energy, unresponsiveness and functional exhaustion of T cells. However, the inhibitory effects of this pathway on the function of cytotoxic T lymphocytes, the main effector cells in HNSCC patients, are not well defined.

In this study aims to solve two main problems: one is to improve and try to optimize current protocols of CTC isolations based on the investigator previous work, which is one of most challenging problems in CTC field to date; the other is to understand the status of immune system in HNSCC patients, especially focusing on PD-1-PD-L1 pathway and its expressions. After series basic experiments of immune cell analysis and conditional adjustment of CTC isolation protocols, the investigator are willing to isolate CTCs and immune cells at a single blood drawing at the same time. A prospective trial will be conducted to elucidate the roles of PD-1 expression lymphocytes and CTC numbers on the clinical outcomes of HNSCC patients.

1. To establish a platform to increase the efficiency and purity for isolation and enumeration of circulating tumor cells from patients with head and neck cancer.
2. Compare the differences and determine the most efficient method or combination of negative, positive selection, optoelectronic dielectrophoresis (ODEP) and flow cytometry sorting technology.

   1. Negative Selection
   2. Positive Selection
   3. ODEP devices
   4. Flow Cytometry and Sorting System
3. Use the upgraded platform and test among different groups for efficiency test. (Planned subjects: healthy donor: n=30; early-stage (stage I=II) patients=9; locally-advanced=9 and metastatic, n=9; total n=60)

   - Clinical Enrollment for Device/Method Validation
4. To confirm programmed death-1(PD-1) expression could be successfully detected and up-regulated on cytotoxic T cells using cell lines natural killer cell (NK-92).

   1. Cell Culture of NK-92, OECM-1, SCC-4 and K562
   2. Immunostaining methods for PD-1 expression
   3. Flow cytometry for ratio of PD-1 expression
5. To observe the functional changes of the cytotoxic T cells with PD-1 expression using cell lines and immunomagnetic bead-based isolation method.

   1. Positive Isolation for PD-1 Expressing Cells
   2. CD107a cytotoxicity assay
   3. Cell-mediated cytotoxicity assays
6. Confirm these findings in whole blood sample from healthy donors (n=15) and HNSCC patients (n=15).

   - Clinical Enrollment Patients for PD-1 expression in PBMCs, a stage of validation previous findings
7. Using the platform established on first-year project, to isolate and check the CTC number from locally advanced or metastatic HNSCC patients for validation.
8. To check the ratio of circulating CD56+ cells with PD-1 expression from locally advanced or metastatic HNSCC patients for validation.
9. To correlate the clinical relevance of circulating PD-1+CD56 cells and CTCs in locally advanced or metastatic HNSCC patients (N=60 in this year). Another Healthy donors (n=15) will be needed for reference.

   1. CTC enumeration and sorting technique-Negative Selection Strategy
   2. Positive Selection
   3. ODEP devices
   4. Flow Cytometry and Sorting System
   5. Clinical Enrollment HNSCC Patients for CTCs and PD-1 ratio

The Clinical Relevance of Immune Cells and CTC in HNSCC Patients

The Clinical Relevance of Immune Cells and Circulating Tumor Cells in Patients With Head and Neck Cancer

The CTCs will be isolated and then the number of CTCs will be measured. PD-1 expression from locally advanced or metastatic HNSCC patients will be validated. Measure response or progression events via all available imaging studies, including Chest-Xray, CT scans, or MRI, PET study. The relationship between CTCs number, PD1 expression and time from CTCs checkpoint to disease progression will be analyzed.

All causes of death would be documented and the relationship between CTCs number and time from CTCs checkpoint to death will be analyzed.

Chang Gung Memorial Hospital

Mouth and Tooth Diseases

Ear, Nose, and Throat Diseases

Carcinoma

Nasopharyngeal Carcinoma

Neoplasms, Glandular and Epithelial

Nasopharyngeal Neoplasms

Pharyngeal Neoplasms

Otorhinolaryngologic Neoplasms

Nasopharyngeal Diseases

Pharyngeal Diseases

Stomatognathic Diseases

Otorhinolaryngologic Diseases

Camurati-Engelmann Disease

Antineoplastic Agents

Antirheumatic Agents

Cyclophosphamide

Fludarabine

Fludarabine phosphate

Immunosuppressive Agents

Immunologic Factors

Antineoplastic Agents, Alkylating

Alkylating Agents

DNR.NPC-specific T cells or DNR.NPC-specific T cells + c/f

Each patient will receive 2 infusions, 14 days apart, according to the following dosing schedule:

Dose Level 1:

Day 0: 2 x 10\^7 cells/m\^2

Day 14: 2 x 10\^7 cells/m\^2

The doses are calculated according to the total T cell number.

DNR.NPC-specific T cells

Patients will receive cyclophosphamide and fludarabine for 3 days before receiving the DNR.NPC-specific T cells.

Each patient will receive infusions according to the following dosing schedule:

Dose Level 2:

Cy/Flu on Days -4 to -2 and then 4 x 10\^7 cells/m\^2 on Day 0, Day 1 or Day 2

Dose Level 3:

Cy/Flu on Days -4 to -2 and then 1 x 10\^8 cells/m\^2 on Day 0, Day 1, or Day 2

DNR.NPC-specific T cells + cyclophosphamide + fludarabine

Patients have nasopharyngeal carcinoma (NPC). This study is a gene transfer research study using special immune cells.

Most patients with NPC show evidence of infection with the virus that causes infectious mononucleosis Epstein Barr virus (EBV) before or at the time of their diagnosis. EBV is found in the cancer cells of almost all patients with advanced stage NPC, suggesting that it may play a role in causing the disease. The cancer cells infected by EBV are able to hide from the body's immune system and escape destruction. We want to see if special white blood cells, called T cells, that have been trained to recognize and kill special parts of EBV infected cells can survive in patient's blood and affect the tumor.

We already have given EBV-specific cytotoxic T cells to 30 patients with active NPC and have seen anti-tumor activity in 14 of 30 patients. We are now trying to find out if we can improve this treatment.

First, we want to give T cells where more of the cells recognize at least two of the four EBV proteins expressed on NPC cells. We call these cells NPC-specific cytotoxic T cells.

Second, we found that T cells work better if we add a receptor to the T cells called DNR (Dominant Negative Receptor). DNR makes T cells resistant to TGFbeta, a factor secreted by cancer cells that helps them escape being killed by the immune system. In this study we will therefore place the DNR gene into NPC-specific T cells (DNR.NPC-specific T cells).

In other clinical studies using T cells, some investigators found that giving chemotherapy before the T cell infusion can improve the amount of time the T cells stay in the body and therefore the effect the T cells can have. Giving chemotherapy before a T cell infusion is called lymphodepletion since the chemotherapy is specifically chosen to decrease the number of lymphocytes in the body. Decreasing the number of patient's lymphocytes first should allow the T cells we infuse to expand and stay longer in their body, and potentially kill cancer cells more effectively.

The chemotherapy we will use for lymphodepletion is a combination of cyclophosphamide and fludarabine. Cyclophosphamide and fludarabine are the chemotherapy agents most commonly used for lymphodepletion in immunotherapy clinical trials.

Blood will be collected from the patient to make LMP/BARF1/EBNA1 (NPC)-specific T cells. To grow NPC-specific T cells we have to use special cells called antigen-presenting cells, which train the patient's T cells to be NPC specific. Antigen presenting cells, so called monocytes or dendritic cells, will be grown/isolated from the patient's blood. In addition, we use a cell line called K562 as antigen-presenting cells that has had genes put inside it, which encourage the patient's T cells to grow. K562 cells are cancer cells. As such, if injected they could cause cancer. The cells have been treated with radiation so they cannot grow.

These antigen-presenting cells are coated with a specially produced mixture of LMP, EBNA1 and BARF protein fragments called peptides. These coated antigen-presenting cells are then used to generate the patient's NPC-specific T cells in the presence of growth factors. To get the DNR to attach to the surface of these NPC-specific T Cells, we also inserted the DNR gene into the NPC-specific T cells (DNR.NPC-specific T cells). This is done with a virus called a retrovirus that has been made for this study. This virus will carry the DNR gene into the cells.

Once we have made sufficient numbers of DNR.NPC-specific T cells we will freeze the cells and test them to make sure they recognize EBV proteins present in NPC.

Patients will get treated with 1) either two doses of DNR.NPC-specific T cells (the second dose will be given 2 weeks after the first dose) or 2)cyclophosphamide and fludarabine for 3 days before receiving the DNR.NPC-specific T cells.

The cyclophosphamide and fludarabine will be given through a needle inserted into a vein or patient's port-a-cath).

The T cells will be thawed and infused through a central line, or through a vein in the patient's arm over 1 to 10 minutes. Patients will be followed in the clinic after the infusion for 1 to 4 hours.

All of the treatments will be given by the Center for Cell and Gene Therapy at Texas Children's Hospital or Houston Methodist Hospital.

Medical tests before treatment:

Before being treated, the patient will receive a series of standard medical tests:

Physical exam Imaging Study Blood tests to measure blood cells, kidney and liver function Measurements of the tumor by routine imaging studies. We will use the imaging study that was used before to follow the patient's tumor: Computer Tomogram (CT), Magnetic Resonance Imaging (MRI), or Positron Emission Tomography (PET/CT)

Medical tests during and after treatment:

The patient will receive standard medical tests when they are getting the infusions and after:

Physical exams Blood tests to measure blood cells, kidney and liver function Imaging study 8 weeks after the 1st T-cell infusion(for patients receiving only DNR.NPC-specific T cells ) or Imaging study 6 weeks after the T-cell infusion (for patients receiving fludarabine and cyclophosphamide before DNR.NPC-specific T-cell infusion).

To learn more about the way the DNR.NPC-specific T cells are working and how long they last in the body, an extra 60ml or 3ml/kg of body weight of blood (whichever is less) will be taken pre-chemotherapy (for the patients receiving chemotherapy), on the day of the T-cell infusion (before and at the end of the T-cell infusion), 1, 2, 3, 4. 6, and 8 weeks( the last time point only for patients receiving DNR.NPC-specific T-cells only) after the T-cell infusion and every 3 months for 1 year, every 6 months for 4 years, then yearly for a total of 15 years. One additional blood sample might be drawn 3 to 4 days post the 1st T-cell infusion; this is optional. This volume is considered safe, but may be decreased if the patient is anemic. In addition to the blood tests, the patient will receive 2 imaging studies as stated above.

During the time points listed above, if the DNR.NPC-specific T cells are found in patient's blood at a certain amount an extra 5ml of blood may need to be collected for additional testing.

TGF-beta Resistant Cytotoxic T-lymphocytes in Treatment of EBV-positive Nasopharyngeal Carcinoma / RESIST-NPC

Administration Of TGF-beta Resistant Cytotoxic T-Lymphocytes to Patients With EBV-positive Nasopharyngeal Carcinoma (RESIST-NPC)

Assess the anti-viral and anti-tumor effects of TGFbeta-resistant NPC specific T cells.

Determine the safety of escalating doses of intravenous infusions of autologous TGFbeta-resistant NPC-specific cytotoxic T-lymphocytes with lymphodepleting chemotherapy for dose levels 2 and 3 in patients with EBV-positive nasopharyngeal carcinoma (NPC).

Determine the survival and the immune function of TGFbeta-resistant NPC specific T cells.

National Cancer Institute (NCI)

Director CAGT

The treatment plan delivers a single dose of Multi-Virus CTL to all patients enrolled on study.

Patients will be studied in cohorts of 3. Eligible patients will receive a single Multi-Virus CTL line infusion 28-100 days after their transplant. The dose will start at dose level 1 (2.0 x 106/kg). After each cohort of 3 patients has been treated at each of the dose levels, decisions will be made if the next high or lower dose level should be used.

Cytotoxic T Lymphocytes

Julie-An Talano, MD

This protocol is a phase I study. Patients may be eligible for an infusion of Multi-virus Cytotoxic T Lymphocytes (CTL) if they received a T-cell depleted (TCD) transplant from a related family member or an unrelated donor. Recipients of these types of transplants are severely immune compromised during the early post-transplant period and are more susceptible to certain viruses. The investigators hypothesize that the adoptive transfer of Cytotoxic T Lymphocytes (CTL) against certain viruses: Adenovirus, Cytomegalovirus and Epstein Barr Virus (Ad, CMV, and EBV) will be safe with regard to producing graft versus host disease (GVHD) or other infusion related toxicities.

Within this clinical trial, the investigators will test the hypotheses that the administration of CTLs for prophylaxis against Ad, CMV and EBV in recipients of TCD-HPCT will be safe and well tolerated. Graded doses of Multi-Virus CTL will be administered to recipients of genotypically haploidentical or mismatched unrelated TCD grafts.

Using Multi-virus Cytotoxic T-cells Following T-Cell Depleted Allogeneic HPCT for Prophylaxis Against EBV, ADV, and CMV

A Phase I Study Of Using Multi-virus Cytotoxic T-cells Following T-cell Depleted Allogeneic Hematopoietic Progenitor Cell Transplantation For Prophylaxis Against Specific Pathogens- Epstein Barr Virus, Adenovirus, And Cytomegalovirus (ACE)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Administration of Rapidly Generated Multivirus-specific Cytotoxic T-Lymphocytes (VIRAGE)	NCT01070797	Adenovirus Infe... Epstein-Barr Vi... Cytomegalovirus... Stem Cell Trans...	Multi-virus Spe...	-	Baylor College of Medicine
TAA-Specific CTLS for Solid Tumors (TACTASOM)	NCT02239861	Rhabdomyosarcom...	TAA-Specific CT...	2 Years - 80 Years	Baylor College of Medicine
The Clinical Relevance of Immune Cells and CTC in HNSCC Patients	NCT02420600	Recurrence Metastasis Death		20 Years -	Chang Gung Memorial Hospital
TGF-beta Resistant Cytotoxic T-lymphocytes in Treatment of EBV-positive Nasopharyngeal Carcinoma / RESIST-NPC	NCT02065362	EBV-positive Na...	DNR.NPC-specifi... DNR.NPC-specifi...	-	Baylor College of Medicine
TGF-beta Resistant Cytotoxic T-lymphocytes in Treatment of EBV-positive Nasopharyngeal Carcinoma / RESIST-NPC	NCT02065362	EBV-positive Na...	DNR.NPC-specifi... DNR.NPC-specifi...	-	Baylor College of Medicine
Using Multi-virus Cytotoxic T-cells Following T-Cell Depleted Allogeneic HPCT for Prophylaxis Against EBV, ADV, and CMV	NCT01535885	Epstein-Barr Vi... Adenovirus Cytomegalovirus...	Cytotoxic T Lym...	- 22 Years	Medical College of Wisconsin

Spots Global Cancer Trial Database for cytotoxic t lymphocytes