CD19-targeting CAR T Cells for B Cell Lymphoma

CD19-targeting CAR T Cells for Refractory B Cell Lymphoma

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

Study Overview

• Status: Withdrawn
• Conditions: B Cell Lymphoma
• Intervention / Treatment: Biological: CD19-targeting CAR T Cells infusion

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.

• Study Type: Interventional
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510000
      • Central laboratory in Fuda cancer hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: No Intervention
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.	Biological: CD19-targeting CAR T Cells infusion; CD19-targeting 2nd generation CAR t cells infusion for refractory B cell lymphoma

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
B cell number and immunoglobulins	Number of blood B cells and immunoglobulins will be evaluated by routine diagnostics	up to 24 months

Collaborators and Investigators

• Sponsor: Fuda Cancer Hospital, Guangzhou

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2015
• Primary Completion (Actual): August 15, 2016
• Study Completion (Actual): August 15, 2016

Study Registration Dates

• First Submitted: September 4, 2015
• First Submitted That Met QC Criteria: September 10, 2015
• First Posted (Estimate): September 14, 2015

Study Record Updates

• Last Update Posted (Actual): July 16, 2020
• Last Update Submitted That Met QC Criteria: July 14, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: Lymphoma; CD19; CAR T Cells
• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Lymphoma, Non-Hodgkin; Lymphoma; Lymphoma, B-Cell
• Other Study ID Numbers: CD19-targeting CAR T