CD20-CD19 Compound CAR (cCAR) T Cells for Patients With Relapsed /Refractory B Cell Malignancies

Last updated: November 8, 2019
Sponsor: iCell Gene Therapeutics
Overall Status: Active - Recruiting

Phase

1

Condition

Lymphocytic Leukemia, Chronic

Chronic Lymphocytic Leukemia

Treatment

N/A

Clinical Study ID

NCT04156178
ICG133-001
  • All Genders

Study Summary

This is a phase I, interventional, single arm, open label, treatment study to evaluate the safety and tolerability of CD20-CD19 cCAR in patients with relapsed and/or refractory B cell malignancies.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Diagnosis based on the World Health Organization (WHO) 2008

  2. Histologically demonstrate CD19 or CD20 expressing B cell lymphoma or B ALL

  3. Patients have exhausted standard therapeutic options

  4. Systematic usage of immunosuppressive drug or corticosteroid must have been stoppedfor more than 4 weeks

  5. Female must be not pregnant during the study

Exclusion

Exclusion Criteria:

  1. Patients declining to consent for treatment

  2. Prior solid organ transplantation

  3. Potentially curative therapy including chemotherapy or hematopoietic cell transplant

  4. Prior treatment with CD20xCD3 or CD19x3 bispecific agents

Study Design

Total Participants: 12
Study Start date:
August 01, 2018
Estimated Completion Date:
September 30, 2020

Study Description

Clinical trials with CD19-directed CARs have achieved unprecedented remission rates as high as 90%. However, recent follow-up studies have shown a substantial portion of treated patients relapsed due to antigen escape. CD20-CD19 cCAR is a compound Chimeric Antigen Receptor (cCAR) immunotherapy with two distinct functional CAR molecules expressed on a T-cell, directed against the surface proteins CD20 and CD19. CD20-CD19 cCAR intends to target the mechanisms of single-CAR relapse, specifically antigen escape.

Connect with a study center

  • Chengdu Military General Hospital

    Chengdu,
    China

    Active - Recruiting

  • Peking University Shenzhen Hospital

    Shanghai,
    China

    Active - Recruiting

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