CD19-targeting CAR T Cells for B Cell Lymphoma

Overview

The purpose of this study is to evaluate the safety and efficacy of CD19-targeting CAR T Cells infusion for B Cell Lymphoma.

Full Title of Study: “CD19-targeting CAR T Cells for Refractory B Cell Lymphoma”

Study Type

• Study Type: Interventional
• Study Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Primary Purpose: Treatment
  • Masking: None (Open Label)
• Study Primary Completion Date: August 15, 2016

Detailed Description

Chimeric antigen receptor (CAR) T cells targeting CD19 will be evaluated for safety and efficacy in patients with B cell lymphoma or leukemia. The CAR consists of a CD19 targeting antibody scFv with two intracellular signaling domains derived from CD3 zeta and CD28. Autologous T cells will be gene-engineered with the CAR gene using a retrovirus vector. Prior to T cell infusion, the patients will be subjected to preconditioning treatment. After T cell infusion, the patients will be evaluated for 24 months for adverse reactions, persistence of CAR T cells and efficacy.

Interventions

• Biological: CD19-targeting CAR T Cells infusion
  • CD19-targeting 2nd generation CAR t cells infusion for refractory B cell lymphoma

Arms, Groups and Cohorts

• Experimental: CAR T cells
  • In interventional studies, participants are assigned to accept CD19-targeting CAR T Cells infusion so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. Arm refers to each group or subgroup of participants in a clinical trial that receives specfic interventions (or no intervention) according to the study protocol. This is decided before the trial begins.
• No Intervention: No Intervention

Clinical Trial Outcome Measures

Primary Measures

• CAR T cell persistence
  • Time Frame: up to 24 months
  • Presence of circulating CAR T cells will be evaluated with flow cytometry and real time PCR in patient blood

Secondary Measures

• Tumor load
  • Time Frame: up to 24 months
  • Tumor load will be quantified with radiology, bone marrow and/or blood samples dependent on diagnosis

Participating in This Clinical Trial

Inclusion Criteria

1. Relapsed or refractory CD19+ B-cell lymphoma. 2. Measurable disease. 3. Performance status ECOG 0-2. 4. Age:18-80. 5. Fertile females/males must consent to use contraceptives during participation of the trial. 6. Signed informed consent Exclusion Criteria:

1. Any significant medical or psychiatric illness that would prevent the patient from giving informed consent or from following the study procedures. 2. Patients with primary CNS lymphoma. 3. Known human immunodeficiency virus (HIV) infection. 4. Active and/or severe infection (e.g. tuberculosis, sepsis and opportunistic infections, active hepatitis B virus (HBV) or active hepatitis C virus (HCV) infection). 5. Other serious underlying medical conditions, which, in the Investigator's judgment, could impair the ability of the patient. 6. Treatment with an investigational product within 30 days prior to enrollment, or at least 5 half lives of that drug, which is longest. 7. Patients that do not consent to that tissue and blood samples are stored in a biobank. 8. Pregnancy.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

• Lead Sponsor
  • Fuda Cancer Hospital, Guangzhou
• Provider of Information About this Clinical Study
  • Sponsor
• Overall Official(s)
  • Lizhi Niu, PhD, Study Chair, Fuda Cancer Hospital