Neoplasms

Heart and Blood Diseases

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Rare Diseases

Multiple Myeloma

Neoplasms, Plasma Cell

Leukemia

Hematologic Neoplasms

Neoplasms by Histologic Type

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hematologic Diseases

Hemorrhagic Disorders

Lymphoproliferative Disorders

Immunoproliferative Disorders

Antineoplastic Agents

All Drugs and Chemicals

Antirheumatic Agents

Etoposide

Gemcitabine

Vinorelbine

Cyclophosphamide

Melphalan

Etoposide phosphate

Carmustine

Immunosuppressive Agents

Immunologic Factors

Antineoplastic Agents, Alkylating

Alkylating Agents

Antimetabolites

Enzyme Inhibitors

Tubulin Modulators

Antimitotic Agents

CIK cells

etoposide

bcnu

cyclophosphamide

gemcitabine

vinorelbine

melphalan

Sally Arai

The purpose of the study is to conduct a phase I study of adoptive immunotherapy with autologous, ex-vivo expanded cytokine-induced killer (CIK) cells to reduce the relapse rate in autologous stem cell transplant patients with high-risk hematologic malignancies.

Disease relapse remains the major cause of treatment failure in autologous stem cell transplantation for patients with high-risk disease. Relapse after autologous transplant is in part due to the persistence of residual cancer cells. Cellular immunotherapy using activated autologous effector cells to recognize and kill tumor targets in a minimal disease state after transplant is a strategy being explored to reduce relapse and improve survival. We hypothesize that cytokine-induced killer (CIK) cell-based immunotherapy can reduce the relapse rate after high-risk autologous stem cell transplantation by treating post-transplant minimal residual disease.

Post-transplant Autologous Cytokine-induced Killer (CIK) Cells for Treatment of High Risk Hematologic Malignancies

A Phase I Study of Post-transplant Autologous Cytokine-induced Killer (CIK) Cells for the Treatment of High-risk Hematologic Malignancies

Assistant Professor of Medicine

Symptoms and General Pathology

Nervous System Diseases

Diseases and Abnormalities at or Before Birth

Syndrome

Anemia

Leukemia, Myeloid

Myeloproliferative Disorders

Preleukemia

Myelodysplastic Syndromes

Spinal Dysraphism

Neural Tube Defects

Bone Marrow Diseases

Precancerous Conditions

Congenital Abnormalities

Nervous System Malformations

Chronic Myeloproliferative Disorders

Spina Bifida

Anti-Infective Agents

Dermatologic Agents

Cyclosporine

Cyclosporins

Mycophenolic Acid

Thymoglobulin

Antilymphocyte Serum

Clotrimazole

Miconazole

Antifungal Agents

Calcineurin Inhibitors

Anti-Bacterial Agents

Antibiotics, Antitubercular

Antitubercular Agents

Target dose of ≥ 5 x 10e6 CD34+ cells/kg of recipient body weight plus an additional 2 x10e9 mononuclear cells.

Mycophenolate Mofetil

Total Lymphoid Irradiation (TLI)

Everett Meyer, MD, PhD

Allogeneic stem cell transplantation (transplant of blood cells from another individual) is a treatment option for patients with myelodysplasia or myeloproliferative Disorders. During the course of this study, it will be evaluated whether a particular type of blood cell, called a cytokine-induced killer (CIK) cell, may add benefit to allogeneic stem cell transplantation. CIK cells are present in small quantities in the bloodstream but their numbers can be expanded after a brief period of nurturing in a laboratory.

Primary Objectives:

To determine the rate of conversion to FDC following infusion of allogeneic CIK cells among patients with MDS, therapy-related myeloid neoplasms, or MPD who receive non myeloablative preparative regimen of TLI / ATG followed by allogeneic HCT and consolidation with allogeneic CIK cells.

Secondary Objectives:

* To determine the 2 year overall survival (OS) and event free survival (EFS)
* To determine the incidence of acute GVHD following infusion of allogeneic CIK cells
* To assess the pre-transplant expression of NKG2D ligands in patients' bone marrow aspirates.

Post T-plant Infusion of Allogeneic Cytokine Induced Killer (CIK) Cells as Consolidative Therapy in Myelodysplastic Syndromes/Myeloproliferative Disorders

Post Transplant Infusion of Allogeneic Cytokine Induced Killer Cells as Consolidative Therapy After Non-Myeloablative Allogeneic Transplantation in Patients With Myelodysplasia or Myeloproliferative Disorders

Proportion of patients achieving full donor T-cell chimerism (FDC) by on or before Day 90 post non-myeloablative allogeneic transplant with allogeneic cytokine-induced killer (CIK) cells will be determined. FDC is defined as the attainment of \>95% donor type CD3+ cells. The outcome will be reported as number of participants who achieved full donor chimerism, a number without dispersion.

Overall survival (OS) is an expression of the number of participants that remain alive 2 years after cytokine-induced killer (CIK) infusion. The outcome will be reported as the number of participants alive 2 years after CIK infusion, a number without dispersion.

Event-free Survival (EFS) rate will be assessed on all enrolled participants and is defined as the duration of time after cytokine-induced killer (CIK) cell infusion that the participants remain alive with experiencing relapse, Grade 3 to 4 acute graft vs host disease (aGVHD), or death. The outcome will be reported as the number of participants, stratified by receipt of CIK cells, that did not experience a specified event, a number without dispersion.

Acute graft vs host disease (aGvHD) Grade 2 to 4 was staged \& graded using modified Keystone criteria, as below. The outcome is reported as the number of participants that experience Grade 2 to 4 aGvHD within 100 days and 1 year.

* Stage 1: Skin: rash \< 25% of skin. Liver: bilirubin 2 to 3 mg/dL. Gut: diarrhea 500 to 1000 mL/day or persistent nausea with positive biopsy for GvHD
* Stage 2: Skin: rash 25 to 50% of skin. Liver: bilirubin 3 to 6 mg/dL. Gut: diarrhea 1000 to 1500 mL/day.
* Stage 3: Skin: rash \> 50% of skin. Liver: bilirubin 6 to 15 mg/dL. Gut: diarrhea \> 1500 mL/day.
* Stage 4: Skin: generalized erythroderma with bulla formation. Liver: bilirubin \> 15 mg/dL. Gut: severe abdominal pain with or without ileus Grade of aGvHD was determined as follows.
* Grade 1: Stage 1-2 Skin + No Liver stage + No Gut stage
* Grade 2: Stage 3 Skin OR Stage 1 Liver or Stage 1 Gut
* Grade 3: No Skin stage + Stage 2 to 3 Liver Stage 2 to 4 Gut
* Grade 4: Stage 4 Skin + or Stage 2

Pre-transplant expression of natural-killer group 2, member D (NKG2D) ligands MIC A, MIC B, and the UL16 binding proteins (ULBPs) will be assessed in participants' bone marrow aspirates. The outcomes is expressed as the number of participants whose expression level for each ligand was elevated compared to background, represented by the known levels for individual without cancer.

Everett Meyer

Assistant Professor-Med

Target dose of ≥ 5 x 106 CD34+ cells/kg of recipient body weight plus an additional 2 x109 mononuclear cells.

CIK cells: Standard of care

Cyclosporine: 5 mg/kg, po

Mycophenolate Mofetil: 15 mg/kg, oral

Thymoglobulin: 7.5 mg/kg, IV

Allogeneic Cytokine Induced Killer Cells (CIK)

Age, Categorical

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Everett Meyer, Assistant Professor of Medicine (Blood and Marrow Transplantation)

Cytokine-induced killer (CIK) cells were infused in a subset of participants.

Full Donor Chimerism (FDC)

Cytokine-induced killer (CIK) cells were infused in a subset of participants. Participants that did not receive CIK cells were not included in this analysis.

Overall Survival (OS)

CIK-infused participants

Non-CIK-infused participants

All participants are reported. Cytokine-induced killer (CIK) cells were infused in a subset of participants.

Event-free Survival (EFS) Rate

All participants within 100 days

All participants within 1 year

CIK-infused participants within 100 days

CIK-infused participants within 1 year

Non-CIK-infused participants within 100 days

Non-CIK-infused participants within 1 year

Target dose of ≥ 5 x 10e6 CD34+ cells/kg of recipient body weight plus an additional 2 x10e9 mononuclear cells.

CIK cells: Standard of care

Cyclosporine: 5 mg/kg, po

Mycophenolate Mofetil: 15 mg/kg, oral

Thymoglobulin: 7.5 mg/kg, IV

Cytokine-induced killer (CIK) cells were infused in a subset of participants. Results are reported for both subsets and collectively, at 2 time points.

Number of Participants That Experience Grade 2 to 4 aGvHD Within 100 Days and 1 Year

Insufficient tumor sample materials from the pre-transplant diagnostic bone marrow aspirate was available for the research analysis. No analysis was conducted.

Pre-transplant Expression of Natural-killer Group 2, Member D (NKG2D) Ligands

CIK Cell Infusion

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Carcinoma

Carcinoma, Renal Cell

Neoplasms, Glandular and Epithelial

Adenocarcinoma

Kidney Neoplasms

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Kidney Diseases

Urologic Diseases

Male Urogenital Diseases

Renal Cell Carcinoma

Clear Cell Renal Cell Carcinoma

Antibodies

Antibodies, Monoclonal

Immunomodulating Agents

Immunoglobulins

Immune Checkpoint Inhibitors

Antineoplastic Agents, Immunological

SHR-1210 \& CIK cells

SHR-1210,200mg/d,intravenous infusion,d1; CIK cells, 1x10\^10 (10 billion ), intravenous infusion,d14; Q3W.

SHR-1210,200mg/d,intravenous infusion,d1; Q3W.

SHR-1210

Xiubao Ren, MD. PhD.

Liang Liu, MD. Ph.D

This randomized, multicenter,open-label, phase II study is to evaluate the effects of PD-1 inhibitor combination with autologous cytokine-induced killer cell immunotherapy in the second-line treatment of patients with metastatic clear cell renal cell carcinoma.

In the experimental group, patients received Camrelizumab injection (SHR-1210) 200mg d1, CIK cells 1x10\^10 d14; Q3W, for 4 cycles; then Camrelizumab injection maintenance treatment for 2 years. In the control group, patients received Camrelizumab injection 200mg d1, Q3W, for 2 years.

Study of PD-1 Inhibitor Combination With Autologous Cell Immunotherapy in the Metastatic Renal Cell Carcinoma

Phase II Clinical Study of PD-1 Monoclonal Antibody Combination With Autologous Cytokine-induced Killer Cell Immunotherapy in the Second-line Treatment of Metastatic Clear Cell Renal Cell Carcinoma

PFS will be calculated from initiation of treatment until first progression, and patients alive in stable state will be censored at the time of last contact.

Tianjin Medical University Cancer Institute and Hospital

Mouth and Tooth Diseases

Ear, Nose, and Throat Diseases

Nasopharyngeal Carcinoma

Neoplasm Metastasis

Nasopharyngeal Neoplasms

Pharyngeal Neoplasms

Otorhinolaryngologic Neoplasms

Head and Neck Neoplasms

Nasopharyngeal Diseases

Pharyngeal Diseases

Stomatognathic Diseases

Otorhinolaryngologic Diseases

Central Nervous System Depressants

Other Dietary Supplements

Cisplatin

Benzocaine

Tannic Acid

A total of 40 patients enrolled will be accept 4 cycles GC chemotherapy(every 4 weeks),then they will randomized divided into two groups. 20 patients will maintain autologous CIK cells for 8 cycles (every 4 weeks); however,the other 20 patients will not accept CIK cells treatment. After the all 40 patients have accomplished 4 cycles GC regimen chemotherapy plus 8 cycles CIK cells treatment or 4 cycles GC chemotherapy alone, the early effects will be assessed and long-term efficacy such as OS and PFS will be evaluated.

A total of 40 patients enrolled will be accept 4 cycles GC chemotherapy(every 4 weeks),then they will randomized divided into two groups. 20 patients will maintain autologous CIK cells for 8 cycles (every 4 weeks);the other 20 patients will not accept CIK cells treatment. After the all 40 patients have accomplished 4 cycles GC regimen chemotherapy plus CIK cells treatment or 4 cycles GC chemotherapy alone, the early effects will be assessed and long-term efficacy such as OS and PFS will be evaluated.

A total of 40 patients enrolled will be accept 4 cycles GC chemotherapy(every 4 weeks),then they will randomized divided into two groups. 20 patients will maintain autologous CIK cells for 8 cycles (every 4 weeks);the other 20 patients will not accept CIK cells treatment. Afer the all 40 patients have accomplished 4 cycles GC regimen chemotherapy plus CIK cells treatment or 4 cycles GC chemotherapy alone, the early effects will be assessed and long-term efficacy such as OS and PFS will be evaluated.

GC chemotherapy plus CIK cells (Gemcitabine, Cisplatin, Autologous CIK cells)

GC chemotherapy (Gemcitabine, Cisplatin)

Jian-jun Li, M.D. Ph.D

Jian-jun Li, M.D. Ph.D.

Jian-jun Li, M.D.

Nasopharyngeal carcinoma (NPC) is one of the most common malignant tumors in Southern China and South Asia. After radiotherapy, some patients with nasopharyngeal carcinoma still had distant metastasis. In recent years, some chemotherapeutic agents, such as gemcitabine, cisplatin, were used to treat patients with advanced nasopharyngeal carcinoma, including those with local recurrence and distant metastases, with a certain short-term effect. However, chemotherapy alone is still not ideal for effectively improving the prognosis of patients with advanced nasopharyngeal carcinoma. Therefore, it is necessary to develop more-effective adjuvant therapies.

CIK cells (cytokine induced killer cells, CIK) are a population of heterogeneous cells generated by the in vitro amplification of mononuclear cells in peripheral blood. The cells are co-induced with multiple cytokines; the lymphocytes with co-expression of CD3+CD56+ have the strongest anti-tumor effect. Because of their non-MHC restricted tumor killing activity, CIK cells have a powerful anti-tumor effect both in vitro and in vivo, which spans a broad anti-tumor spectrum.

In this study, the patients with post-radiotherapy distant metastasis of NPC will be treated with autologous CIK cells in combination with Gemcitabine plus Cisplatin regimen chemotherapy(GC). The purpose of this study is to observe and evaluate the toxic side effects and the short- and long-term efficacy of CIK used in combination with GC chemotherapy to treat NPC in patients with distant metastasis after radiotherapy. Patients and Methods: 40 patients with distant metastasis after radiotherapy will accept 4 cycles chemotherapy of Gemcitabine plus cisplatin regimen and then are randomized divided into 2 groups. The 20 patients in GC+CIK group will be treated with maintaining therapy of adoptive autologous CIK cell transfusion sequentially; the other 20 patients will be followed-up only without CIK cells treatment. The safety of chemotherapy and CIK cells transfusion and the tumor regression status will be observed. The early response and long-term efficacy of two groups patients who accept GC chemotherapy or GC +CIK bio-therapy will be investigated.

GC Regimen Chemotherapy Plus CIK Cells for Metastatic Nasopharyngeal Carcinoma

Autologous Cytokine-Induced Killer Cell Transfusion in Combination With Gemcitabine Plus Cisplatin Regimen Chemotherapy for Metastatic Nasopharyngeal Carcinoma

(According to the response criteria in solid tumor(RECIST), version 1.1)

Complete remission (CR):Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm.

Partial remission (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters;

Stable disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study ;

Progressive disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).

OS is defined as the time from randomization until death from any cause;

TTP is defined as the time from randomization until objective tumor progression; TTP does not include deaths;

PFS is defined as the time from randomization until objective tumor progression or death.

Sun Yat-sen University

Associate Professor

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Post-transplant Autologous Cytokine-induced Killer (CIK) Cells for Treatment of High Risk Hematologic Malignancies	NCT00477035	Leukemia Multiple Myelom...	CIK cells etoposide bcnu cyclophosphamid... gemcitabine vinorelbine melphalan	18 Years - 75 Years	Stanford University
Post T-plant Infusion of Allogeneic Cytokine Induced Killer (CIK) Cells as Consolidative Therapy in Myelodysplastic Syndromes/Myeloproliferative Disorders	NCT01392989	Neural Tube Def... Anemia Leukemia, Myelo... Bone Marrow Tra... Myelodysplastic... Myeloproliferat...	CIK cells Cyclosporine Mycophenolate M... Thymoglobulin Total Lymphoid ...	50 Years -	Stanford University
Study of PD-1 Inhibitor Combination With Autologous Cell Immunotherapy in the Metastatic Renal Cell Carcinoma	NCT03987698	Renal Cell Carc... Clear Cell Rena...	SHR-1210 CIK cells	18 Years - 75 Years	Tianjin Medical University Cancer Institute and Hospital
GC Regimen Chemotherapy Plus CIK Cells for Metastatic Nasopharyngeal Carcinoma	NCT01655628	Stage IV Nasoph...	GC chemotherapy... GC chemotherapy...	18 Years - 60 Years	Sun Yat-sen University
Post T-plant Infusion of Allogeneic Cytokine Induced Killer (CIK) Cells as Consolidative Therapy in Myelodysplastic Syndromes/Myeloproliferative Disorders	NCT01392989	Neural Tube Def... Anemia Leukemia, Myelo... Bone Marrow Tra... Myelodysplastic... Myeloproliferat...	CIK cells Cyclosporine Mycophenolate M... Thymoglobulin Total Lymphoid ...	50 Years -	Stanford University

Spots Global Cancer Trial Database for cik cells

Every month we try and update this database with for cik cells cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for cik cells

Every month we try and update this database with for cik cells cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for cik cells cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.