CD4-specific CAR T Cells (CD4 CAR T Cells) for Relapsed/Refractory T Cell Malignancies


This is a phase I, interventional, single arm, open label, treatment study to evaluate the safety and tolerability of CD4 CAR T cells in patients with relapsed and/or refractory T cell lymphoma.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Sequential Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: October 2021

Detailed Description

CD4-specific CAR is a chimeric antigen receptor immunotherapy treatment designed to treat lymphoma/leukemia expressing CD4 antigen. CD4+ T cell lymphomas are a subset of leukemias and lymphomas that are positive for the surface protein CD4. The purpose of this study is to evaluate the efficacy and safety of CD4 CAR T cells.


  • Biological: CD4 CAR T cells
    • CD4 CAR 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: CD4 CAR T cells
    • Dose escalation phase: CD4 CAR T cells transduced with a lentiviral vector to express CD4 chimeric receptor domain on T cells with an escalation approach, 2e6 to 5e6 CAR-T cells/kg

Clinical Trial Outcome Measures

Primary Measures

  • Number of adverse events after CD4 CAR T cells cell infusion
    • Time Frame: 2 years particularly the first 28 days after infusion
    • Determine the toxicity profile of CD4 CAR T cell therapy

Secondary Measures

  • Incidence of treatment-emergent adverse events
    • Time Frame: up to 6 months
    • Incidence of treatment-emergent adverse events
  • Disease Free Survival (DFS)
    • Time Frame: up to 2 years
    • Disease Free Survival (DFS) (IMWG criteria)
  • Progression-Free Survival (PFS)
    • Time Frame: up to 2 years
    • Progression-Free Survival (IMWG criteria)
  • Overall Survival (OS)
    • Time Frame: up to 2 years
    • overall survival

Participating in This Clinical Trial

Inclusion Criteria

  • Signed written informed consent; Patients volunteer to participate in the research – Diagnosis is mainly based on the World Health Organization (WHO) 2008 – Patients have exhausted standard therapeutic options – Systematic usage of immunosuppressive drug or corticosteroid must have been stopped for more than 1 weeks – Female must be not pregnant during the study Exclusion Criteria:

  • Patients declining to consent for treatment – Prior solid organ transplantation – Potentially curative therapy including chemotherapy or hematopoietic cell transplant – Any drug used for GVHD must be stopped >1 week

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • iCell Gene Therapeutics
  • Collaborator
    • iCAR Bio Therapeutics Ltd.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Hongyu Zhang, MD/PhD, Principal Investigator, Peking University Shenzhen Hospital, China
    • Fang Liu, MD/PhD, Principal Investigator, Chengdu Military Hospital
  • Overall Contact(s)
    • Kevin Pinz, MS, 6315386218,

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