Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Skin and Connective Tissue Diseases

Digestive System Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Blood and Lymph Conditions

Immune System Diseases

Mouth and Tooth Diseases

Heart and Blood Diseases

Rare Diseases

Carcinoma, Non-Small-Cell Lung

Breast Neoplasms

Stomach Neoplasms

Carcinoma

Carcinoma, Squamous Cell

Lung Neoplasms

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Esophageal Neoplasms

Pancreatic Neoplasms

Lymphoma

Adenocarcinoma

Cholangiocarcinoma

Leukemia

Leukemia, Lymphoid

Melanoma

Carcinoma, Renal Cell

Liver Neoplasms

Head and Neck Neoplasms

Carcinoma, Transitional Cell

Lymphoma, Mantle-Cell

Lymphoma, Follicular

Lymphoma, B-Cell, Marginal Zone

Lymphoma, Large B-Cell, Diffuse

Lymphoma, B-Cell

Mouth Neoplasms

Kidney Neoplasms

Waldenstrom Macroglobulinemia

Lymphoma, Non-Hodgkin

Fallopian Tube Neoplasms

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Neoplasms, Glandular and Epithelial

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

Hematologic Diseases

Fallopian Tube Diseases

Neoplasms, Plasma Cell

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hemorrhagic Disorders

Liver Diseases

Stomach Cancer

Ovarian Cancer

Ovarian Epithelial Cancer

Esophageal Cancer

Pancreatic Cancer

Lymphosarcoma

Bile Duct Cancer

Renal Cell Carcinoma

Clear Cell Renal Cell Carcinoma

Transitional Cell Carcinoma

Mantle Cell Lymphoma

Follicular Lymphoma

B-cell Lymphoma

Marginal Zone Lymphoma

Diffuse Large B-Cell Lymphoma

Fallopian Tube Cancer

Oral Cancer

Laryngeal Cancer

Indolent B Cell Lymphoma

Lip and Oral Cavity Cancer

All Drugs and Chemicals

Antineoplastic Agents

Hematinics

Gastrointestinal Agents

Amino Acids

Antibodies

Paclitaxel

Gemcitabine

Pembrolizumab

Albumin-Bound Paclitaxel

Immunoglobulins

Liver Extracts

Pancrelipase

Pancreatin

Flt3 ligand protein

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

Tyrosine

Part 1: Eligible patients will receive CDX-1140, based on cohort assigned, in 4 week cycles until progression, intolerance, or two years of treatment.

Part 2: Eligible patients will receive CDX-1140, based on cohort assigned, in 4 week cycles until progression, intolerance or two years of treatment. A fixed dose of CDX-301 is injected once a day for five days before cycles 1 and 2 of CDX-1140.

Part 3: Eligible patients will receive CDX-1140, based on cohort assigned, in 3 week cycles until progression, or intolerance, or two years of treatment. A fixed dose of pembrolizumab will also be given in 3 week cycles.

Part 4: Eligible patients will receive CDX-1140, based on cohort assigned, in 4 week cycles until progression, or intolerance, or two years of treatment. Chemotherapy will also be given according to standard of care.

CDX-1140 will be administered every 4 weeks in Parts 1, 2 and 4, and every 3 weeks in Part 3.

CDX-1140

CDX-301 will be injected once a day for five days before Cycles 1 and 2.

CDX-301

pembrolizumab will be administered every 3 weeks.

pembrolizumab

Gemcitabine and Nab-paclitaxel will be administered on Day 1, Day 8 and Day 15 of each 4 week Cycle.

Chemotherapy

This is a study to determine the maximum tolerated dose (MTD) for CDX-1140 (CD40 antibody), either alone or in combination with CDX-301 (FLT3L), pembrolizumab, or chemotherapy and to further evaluate its tolerability and efficacy in expansion cohorts once the MTD is determined.

This study will determine the MTD of CDX-1140 while also evaluating the safety, tolerability and efficacy of CDX-1140 alone (Part 1) or in combination with CDX-301 (Part 2), pembrolizumab (Part 3), or chemotherapy (Part 4) in patients with cancer.

Eligible patients that enroll to the dose-escalation portion of the study will be assigned to one of several dose levels of CDX-1140. The dose-escalation part of the study will test the safety profile of CDX-1140, alone or in combination with CDX-301, pembrolizumab or chemotherapy and determine which dose(s) of CDX-1140 will be studied in the expansion portions of the study.

All patients enrolled in the study will be closely monitored to determine if there is a response to the treatment as well as for any side effects that may occur.

A Study of CDX-1140 (CD40) as Monotherapy or in Combination in Patients With Advanced Malignancies

A Phase 1 Study of CDX-1140 as Monotherapy or in Combination in Patients With Advanced Malignancies

The rates of drug-related adverse events will be summarized and maximum tolerated dose will be determined.

The percentage of patients who achieved a confirmed complete response or partial response by evaluation criteria in solid tumors for immune-based therapeutics (iRECIST; for solid tumor patients) and the lymphoma response to immunomodulatory therapy criteria (LYRIC; for lymphoma patients).

The percentage of patients who achieve best response of confirmed CR or PR, or stable disease (SD) for at least four months

The interval from which measurement criteria are first met for CR or PR until the first date that progressive disease is objectively documented

The time from start of study drug to time of progression or death, whichever occurs first

The time from start of study drug to death

Serum samples will be obtained for assessment of human anti-CDX-1140 and anti-CDX-301 antibodies

CDX-1140 and CDX-301 concentrations will be measured

Merck Sharp & Dohme LLC

Celldex Therapeutics

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Skin Neoplasms

Skin Diseases

Neuroendocrine Tumor

Neuroepithelioma

Antirheumatic Agents

Pharmaceutical Solutions

Cyclophosphamide

Treatments once a week with 2.5x10e11 VP AdCD40L, maximum 4 treatments (total dose 1x10e12 VP). If no effect in less than 2 out of 6 melanoma patients, the following 9 melanoma patients and 6 patients with other solid tumors will receive preconditioning therapy 1-2 days prior to first and last treatment with 300mg/m2 cyclophosphamid. The next 9 melanoma patients will receive one local radiotherapy.

Adenoviral serotype 5 vector, E1/E3 deleted. Human CD40L gene insert driven by RSV promoter. Vector diluted in infusion solution, 500uL solution containing 2.5x10e11 VP is intratumorally injected/treatment.

AdCD40L

Thomas H Tötterman, MD, PhD

Gustav Ullenhag, MD, PhD

Angelica SI Loskog, PhD

In this phase I/II trial, immunostimulatory gene therapy (AdCD40L) will be investigated. In Part 1 patients with melanoma will receive AdCD40L as mono therapy. In Part 2A, patients with melanoma and patients with other solid tumors will receive AdCD40L in combination with low dose cyclophosphamide. In Part 2B, patients with melanoma will receive AdCD40L in combination with one local radiotherapy and cyclophosphamide.

In this phase I/II trial, immunostimulatory gene therapy (AdCD40L) will be investigated. In Part 1 patients with melanoma (n=6) will receive AdCD40L as mono therapy. In Part 2A, patients with melanoma (n=9) and patients with other solid tumors (n=6) will receive AdCD40L in combination with low dose cyclophosphamide. In Part 2B, patients with melanoma will receive AdCD40L in combination with one local radiotherapy and cyclophosphamide. AdCD40L is given by weekly injections of 2.5x10e11 VP, 4x; total dose 1x10e12 VP. A maximum of 30 patients will be included in this trial.

AdCD40L is an adenoviral nonreplicating vector carrying the human CD40L gene. AdCD40L infects tumor cells upon intratumoral injection and deliver the CD40L gene into the cells whereupon the virus is destroyed. CD40L is then expressed as a membrane-bound protein and interacts with the CD40 receptor expressed by for example dendritic cells (DCs) in the tumor area. DCs mature upon CD40/CD40L interactions and activates tumor-specific T cell responses.

Phase I/IIa AdCD40L Immunogene Therapy for Malignant Melanoma and Other Solid Tumors

Phase I/IIa AdCD40L Immunogene Therapy for Patients With Advanced Malignant Disease.

Adverse events will be documented such as inflammation, fever, pain, changes in blood pressure, pulse etc.

Immune reactions to adenovirus will be measured by evaluating the increase of anti-adenoviral antibodies in the patients at different time points using an ELISA. Spreading of vector will be evaluated by real time PCR to detect adenovirus vector copies in blood (plasma and erythrocyte fraction).

Uppsala University Hospital

Uppsala University

Chronic Graft Versus Host Disease

Analgesics

Interleukin-2

Denileukin diftitox

Immunotoxins

Analgesics, Non-Narcotic

Immunoconjugates

Immunologic Factors

Patients will be treated with six subcutaneous injections of their IL-2-secreting and hCD40L-expressing autologous B-CLL cells, separated by one to two weeks in an immunological treatment window

IL-2 secreting and hCL4OL-expressing autologous B-CLL cells

subcutaneous (SC) injections of autologous leukemic cells modified ex vivo to secrete human interleukin-2 (hIL-2) and to express human CD40 ligand (hCD40L).

IL-2

CD40L

an interleukin-2 immunotoxin directed to the CD25 antigen (denileukin diftitox, ONTAK

ONTAK

immunotoxin dose

GEORGE CARRUM, MD

Malcolm K Brenner, MD

In the laboratory, we will put a special gene into cancer cells that have been taken from the subject. This gene will make the cells produce interleukin 2 (IL-2), which may help the patient's immune system kill cancer cells. Also, we will use CD40 ligand (CD40L) with the IL-2. Studies of cancers in animals and in cancer cells that are grown in laboratories have suggested adding the CD40L helps the IL-2 work better. Some of these new cells will then be given back to the subject as a vaccine shot.

We believe that a part of the subject's immune system (cells called T-reg cells) might try to kill off these special cells. If the T-reg cells do that, the vaccine would not work as well or last as long. To try to avoid this, before the special cells are put back into the subject's body, we will give them an intravenous (IV) dose of IL-2 immunotoxin (called denileuk diftitox or ONTAK). ONTAK should get rid of some of the T-reg cells in the subject's body which should help the special cells work better and longer.

The purpose of this study is to learn the safety and cancer-fighting effects of using IL-2 with the vaccine.

This is a phase I trial to assess the safety of depleting regulatory T (Treg) cells using 1-3 doses of an interleukin-2 immunotoxin directed to the CD25 antigen (denileukin diftitox, ONTAK) in chronic lymphocytic leukemia (B-CLL) patients, followed by six subcutaneous (SC) injections of autologous leukemic cells modified ex vivo to secrete human interleukin-2 (hIL-2) and to express human CD40 ligand (hCD40L). Patients will receive a fixed dose (2 x 10e7) of IL-2 secreting B-cells together with 2 x 10e7 hCD40L expressing B-cells, representing a safe, well tolerated and immunogenic dose in our previous dose escalation study.

All eligible patients will be treated with six injections. Any patient whose disease regresses after the administration of 6 injections may be offered further injections of tumor vaccine if sufficient vaccine is available. There will be no use of placebo or control subjects.

Lymphocytic B-Leukemia (B-CLL) w/Human IL-2 Gene Modified & Human CD40 Ligand-Expressing Autologous Tumor Cells

Treatment of Chronic Lymphocytic B-Leukemia (B-CLL) With Human IL-2 Gene Modified and Human CD40 Ligand-Expressing Autologous Tumor Cells After Depletion of Regulatory T Cells

The Methodist Hospital Research Institute

Center for Cell and Gene Therapy, Baylor College of Medicine

Baylor College of Medicine

Principal Investigator

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Study of CDX-1140 (CD40) as Monotherapy or in Combination in Patients With Advanced Malignancies	NCT03329950	Melanoma Non-small Cell ... Breast Cancer Gastric Cancer Renal Cell Carc... Ovarian Cancer Cholangiocarcin... Bladder Urothel... Pancreatic Aden... Colorectal Canc... Esophageal Canc... Hepatic Cancer Head and Neck C... Primary Periton... Fallopian Tube ... Other Solid Tum... Diffuse Large B... Mantle Cell Lym... Indolent B-cell... Non-Hodgkin Lym... Follicular Lymp... Lymphoplasmacyt... Waldenstrom's D... Marginal Zone L... Mucosa Associat... Small Lymphocyt...	CDX-1140 CDX-301 pembrolizumab Chemotherapy	18 Years -	Celldex Therapeutics
Phase I/IIa AdCD40L Immunogene Therapy for Malignant Melanoma and Other Solid Tumors	NCT01455259	Malignant Melan...	AdCD40L	18 Years -	Uppsala University
Lymphocytic B-Leukemia (B-CLL) w/Human IL-2 Gene Modified & Human CD40 Ligand-Expressing Autologous Tumor Cells	NCT00224354	CHRONIC LYMPHOC...	IL-2 secreting ... IL-2 CD40L ONTAK immunotoxin dos...	18 Years -	Baylor College of Medicine
A Study of CDX-1140 (CD40) as Monotherapy or in Combination in Patients With Advanced Malignancies	NCT03329950	Melanoma Non-small Cell ... Breast Cancer Gastric Cancer Renal Cell Carc... Ovarian Cancer Cholangiocarcin... Bladder Urothel... Pancreatic Aden... Colorectal Canc... Esophageal Canc... Hepatic Cancer Head and Neck C... Primary Periton... Fallopian Tube ... Other Solid Tum... Diffuse Large B... Mantle Cell Lym... Indolent B-cell... Non-Hodgkin Lym... Follicular Lymp... Lymphoplasmacyt... Waldenstrom's D... Marginal Zone L... Mucosa Associat... Small Lymphocyt...	CDX-1140 CDX-301 pembrolizumab Chemotherapy	18 Years -	Celldex Therapeutics

Spots Global Cancer Trial Database for cd40l

Every month we try and update this database with for cd40l 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 cd40l

Every month we try and update this database with for cd40l 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 cd40l 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.