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

NCT02456350 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2016-08-03

No results posted yet for this study

Summary

Autologous T cells engineered to express an anti-CD19 chimeric antigen receptor (CAR) with a safety switch 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 85 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 and a CD3 zeta as costimulatory domains as well as a safety switch.
* 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

DRUG

Fludarabine

On days -5 through -3, Fludarabine 30mg/m2 IV will be infused over 30 minutes.

DRUG

Cyclophosphamide

On days -5 through -3, 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 (2-4 days after the last dose of fludarabine).

Sponsors & Collaborators

  • Shenzhen Institute for Innovation and Translational Medicine

    collaborator OTHER

  • Shenzhen Second People's Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2015-04-30
Primary Completion
2019-12-31
Completion
2019-12-31

Countries

  • China

Study Locations

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Entities

Drugs
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 NCT02456350 on ClinicalTrials.gov