CD5CAR-T: Anti-CD5 CAR T Cells for Relapsed/Refractory T Cell Malignancies

Sponsor
iCell Gene Therapeutics (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04594135
Collaborator
iCAR Bio Therapeutics Ltd. (Industry), Peking University Shenzhen Hospital (Other)
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Study Details

Study Description

Brief Summary

This is a phase I, interventional, single arm, open label, treatment study to evaluate the safety and tolerability of anti-CD5 CART cells in patients with relapsed and/or refractory T cell lymphoma or leukemia.

Condition or Disease Intervention/Treatment Phase
  • Drug: anti-CD5 CAR T cells
Phase 1

Detailed Description

Anti- CAR is a chimeric antigen receptor immunotherapy treatment designed to treat lymphoma/leukemia expressing CD5 antigen. CD5+ T cell lymphomas or leukemia are a subset of leukemias and lymphomas that are positive for the surface protein CD5. The purpose of this study is to evaluate the efficacy and safety of anti-CD5 CAR T cells.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
N/A
Intervention Model:
Sequential Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Anti-CD5 CAR T Cells for Relapsed/Refractory T Cell Malignancies
Actual Study Start Date :
Dec 1, 2020
Anticipated Primary Completion Date :
Nov 30, 2023
Anticipated Study Completion Date :
Nov 30, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: anti-CD5 CAR T cells

Experimental: anti-CD5 CAR T cells Dose escalation phase: anti-CD5 CAR T cells transduced with a lentiviral vector to express CD5 chimeric receptor domain on T cells with an escalation approach, 1e6 to 5e6 CAR-T cells/kg

Drug: anti-CD5 CAR T cells
anti-CD5 CAR T cells transduced with a lentiviral vector to express CD5 chimeric receptor domain on T cells

Outcome Measures

Primary Outcome Measures

  1. Number of adverse events after anti-CD5 CAR T cells cell infusion [2 years particularly the first 28 days after infusion]

    Determine the toxicity profile of anti-CD5 CAR T cell therapy

Secondary Outcome Measures

  1. Incidence of treatment-emergent adverse events [up to 6 months]

    Incidence of treatment-emergent adverse events

  2. Disease Free Survival (DFS) [up to 2 years]

    Disease Free Survival (DFS)

  3. Progression-Free Survival (PFS) [up to 2 years]

    Progression-Free Survival (PFS)

  4. Overall Survival (OS) [up to 2 years]

    Overall Survival (OS)

Eligibility Criteria

Criteria

Ages Eligible for Study:
8 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  1. Signed written informed consent; Patients volunteer to participate in the research

  2. Diagnosis is mainly based on the World Health Organization (WHO) 2008

  3. Patients have exhausted standard therapeutic options

  4. Systematic usage of immunosuppressive drug or corticosteroid must have been stopped for more than 1 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. Any drug used for GVHD must be stopped >1 week

Contacts and Locations

Locations

Site City State Country Postal Code
1 Peking University Shenzhen Hospital Shenzhen Guangdong China

Sponsors and Collaborators

  • iCell Gene Therapeutics
  • iCAR Bio Therapeutics Ltd.
  • Peking University Shenzhen Hospital

Investigators

  • Principal Investigator: Hongyu Zhang, MD/PhD, Peking University Shenzhen Hospital, China

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
iCell Gene Therapeutics
ClinicalTrials.gov Identifier:
NCT04594135
Other Study ID Numbers:
  • ICG190-001
First Posted:
Oct 20, 2020
Last Update Posted:
Mar 2, 2021
Last Verified:
Feb 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by iCell Gene Therapeutics
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 2, 2021