Menu
Peptide Database
Results
No peptides found
Featured

Use search to browse all 100+ peptides

Thymalin

Thymulin, Thymic Factor, Serum Thymic Factor, Facteur Thymique Serique

Quick Stats
Studies 202
Trials 37
Active Not Recruiting PHASE1 INTERVENTIONAL NCT04007029

Modified Immune Cells (CD19/CD20 CAR-T Cells) in Treating Patients With Recurrent or Refractory B-Cell Lymphoma or Chronic Lymphocytic Leukemia

View on ClinicalTrials.gov Updated Dec 15, 2025

Brief Summary

This phase I trial studies the side effects and best dose of CD19/CD20 chimeric antigen receptor (CAR) T-cells when given together with chemotherapy, and to see how effective they are in treating patients with non-Hodgkin's B-cell lymphoma or chronic lymphocytic leukemia that has come back (recurrent) or has not responded to treatment (refractory). In CAR-T cell therapy, a patient's white blood cells (T cells) are changed in the laboratory to produce an engineered receptor that allows the T cell to recognize and respond to CD19 and CD20 proteins. CD19 and CD20 are commonly found on non-Hodgkin?s B-cell lymphoma and chronic lymphocytic leukemia cells. Chemotherapy drugs such as fludarabine phosphate and cyclophosphamide can control cancer cells by killing them, by preventing their growth, or by stopping them from spreading. Combining CD19/CD20 CAR-T cells and chemotherapy may help treat patients with recurrent or refractory B-cell lymphoma or chronic lymphocytic leukemia.

Detailed Description

PRIMARY OBJECTIVES: I. To evaluate the safety of the autologous anti-CD19/anti-CD20 CAR-expressing naive/memory T cells (CART19/20), including determination of the maximum tolerated dose and assessment for replication competent lentivirus (RCL). SECONDARY OBJECTIVES: I. Clinical response. Ia. Overall response rate. Ib. Duration of remission. Ic. Progression-free survival. Id. Overall survival. II. CD19/CD20 bispecific CAR transgenic T-cell persistence. IIa. T-cell monitoring and analyses. IIb. Evidence of B-cell aplasia. EXPLORATORY OBJECTIVES: I. To determine the serum levels of cytokines associated with cytokine release syndrome (CRS) in subjects exhibiting \> grade-2 CRS following CART19/20 cell treatment. OUTLINE: This is a dose-escalation study of CD19/CD20 CAR-T cells. CONDITIONING CHEMOTHERAPY: Patients receive fludarabine phosphate intravenously (IV) over 30 minutes and cyclophosphamide IV over 60 minutes 5, 4, and 3 days before cell infusion. T-CELL INFUSION: Patients receive CD19/CD20 CAR-T cells IV on day 0. Patients with cytokine release syndrome may also receive tocilizumab IV on day 2 at the discretion of the clinical investigator. After completion of study treatment, patients are followed up daily for 14 days, on days 30, 45, 60, 70, 90, and 120, every 3 months for 2 years, every 6 months for 3 years, and then annually for a minimum of 15 years.

Interventions

Name: Chimeric Antigen Receptor T-Cell Therapy
Type: BIOLOGICAL
Description: Given Autologous anti-CD19/anti-CD20 CAR-expressing naive/memory T cells IV
Name: Cyclophosphamide
Type: DRUG
Description: Given IV
Name: Fludarabine Phosphate
Type: DRUG
Description: Given IV
Name: Tocilizumab
Type: BIOLOGICAL
Description: Given IV

Primary Outcomes

Measure: Incidence of adverse events
TimeFrame: Up to 28 days from infusion
Description: Will be assessed according to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0, with the exception of cytokine release syndrome (CRS), which will be graded on the American Society for Transplantation and Cellular Therapy (ASTCT) Consensus Grading for CRS scale. Simple descriptive statistics will be used to summarize toxicities observed after each transgenic T-cell infusion in terms of type (organ affected or laboratory determination such as absolute neutrophil count), severity (by CTCAE toxicity table) and minimum or maximum values for laboratory measures, time of onset, duration, and reversibility or outcome. Tables will be created to summarize these toxicities and side effects. Adverse events will be tabulated by treatment group and will include the number of patients for whom the event occurred, the rate of occurrence, and the severity and relationship to study drug.
Measure: Dose-limiting toxicities
TimeFrame: Up to 28 days from infusion
Description: Will be assessed per CTCAE version 5.0 with the exception of CRS as mentioned above.

Trial Information

NCT ID

NCT04007029

Status

Active Not Recruiting

Study Type

INTERVENTIONAL

Phases

PHASE1

Sponsor

Jonsson Comprehensive Cancer Center

Last Updated

December 15, 2025