MedTrace Logo

Anti-CD19 Chimeric Antigen Receptor (CAR)-Transduced T Cell Therapy for Patients With B Cell Malignancies

NCT03076437 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2021-03-19

No results posted yet for this study

Summary

Autologous T cells engineered to express an anti-CD19 chimeric antigen receptor (CAR) will be infused back to patients with B cell malignancies, including lymphoma and leukemia. The patients will be monitored after infusion of anti-CD19 CAR-transduced T cells for adverse events, persistence of anti-CD19 CAR-transduced T cells and treatment efficacy.

Objectives:

To evaluate the safety and the efficacy of anti-CD19 CAR-transduced T cell therapy for patients with B cell malignancies.

Eligibility:

Patients between 1 and 80 years of age, who have relapsed or refractory CD19-expressing B-cell malignancies (leukemia or lymphoma) that have not responded to standard treatments.

Patients with a history of allogeneic stem cell transplant who meet all eligibility criteria are eligible to participate.

Patients must have adequate organ functions.

Design:

Peripheral blood from patients will be collected for isolation of peripheral blood mononuclear cells (PBMCs), which will be transduced with a lentiviral or retroviral vector encoding anti-CD19 CAR containing a CD28 or 4-1BB and a CD3 zeta as costimulatory domains.

Patients will receive a lymphodepleting preconditioning regimen to prepare their immune system to accept modified T cells.

Patients will receive an infusion of their own modified T cells. They will remain in the hospital to be monitored for adverse events until they have recovered from the treatment.

Patients will have frequent follow-up visits to monitor the persistence of modified T cells and efficacy of the treatment.

Conditions

Interventions

COMBINATION_PRODUCT

Drugs and Anti-CD19-CAR transduced T cells

Drug: Fludarabine On days -4 through -2, Fludarabine 30mg/m2 IV will be infused over 30 minutes. Drug: Cyclophosphamide On days -4 through -2, Cyclophosphamide 300mg/m2 IV will be infused over 60 minutes followed by fludarabine. Biological: Anti-CD19-CAR transduced T cells Modified cells will be infused IV over 30 minutes (1-3 days after the last dose of fludarabine).

Sponsors & Collaborators

  • Dongguan People's Hospital

    collaborator OTHER_GOV

  • Shenzhen Institute for Innovation and Translational Medicine

    lead OTHER

Principal Investigators

  • Mingjun Wang, MD,PhD · Shenzhen Institute for Innovation and Translational Medicine

  • Yirong Jiang, MD · Dongguan People's Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
1 Year
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-01-15
Primary Completion
2019-05-26
Completion
2019-12-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03076437 on ClinicalTrials.gov