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

Overview

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.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: September 30, 2020

Detailed 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.

Interventions

  • Biological: CD20-CD19 cCAR T cells
    • CD20-CD19 cCAR T cells administered to patients, will be either fresh or thawed CAR T cells by IV injection after receiving lymphodepleting chemotherapy

Arms, Groups and Cohorts

  • Experimental: CD20-CD19 cCAR T cells
    • CD20-CD19 cCAR T cells transduced with a lentiviral vector to express two distinct units of anti-CD20 and CD19 CARs

Clinical Trial Outcome Measures

Primary Measures

  • Number of participants with dose limiting toxicity (DLT) as assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
    • Time Frame: 28 days
  • Type of dose-limiting toxicity (DLT)
    • Time Frame: 28 days
  • Number of participants with adverse event by severity as assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
    • Time Frame: 2 years

Secondary Measures

  • Overall Response Rate (ORR)
    • Time Frame: 1 year
    • Assessment of morphologic complete remission (CR), complete remission with incomplete recovery of counts (CR1), no residual disease as analyzed by flow cytometry analysis, and molecular remission by molecular studies
  • Progression-free survival (PFS)
    • Time Frame: 1 year
  • Overall survival
    • Time Frame: 1 year

Participating in This Clinical Trial

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 stopped for more than 4 weeks

5. Female must be not pregnant during the study

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

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • iCell Gene Therapeutics
  • Collaborator
    • Peking University Shenzhen Hospital
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Hongyu Zhang, MD, PhD, Principal Investigator, Peking University Shenzhen Hospital
    • Fang Liu, MD, PhD, Principal Investigator, Chengdu Military General Hospital
  • Overall Contact(s)
    • Kevin Pinz, 6315386218, kevin.pinz@icellgene.com

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