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

Primary Purpose

T-cell Acute Lymphoblastic Leukemia, T-cell Non-Hodgkin Lymphoma

Status
Recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
anti-CD5 CAR T cells
Sponsored by
iCell Gene Therapeutics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for T-cell Acute Lymphoblastic Leukemia focused on measuring anti-CD5 CAR, T cell leukemia/lymphoma, T-ALL

Eligibility Criteria

8 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Peking University Shenzhen HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

anti-CD5 CAR T cells

Arm Description

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

Outcomes

Primary Outcome Measures

Number of adverse events after anti-CD5 CAR T cells cell infusion
Determine the toxicity profile of anti-CD5 CAR T cell therapy

Secondary Outcome Measures

Incidence of treatment-emergent adverse events
Incidence of treatment-emergent adverse events
Disease Free Survival (DFS)
Disease Free Survival (DFS)
Progression-Free Survival (PFS)
Progression-Free Survival (PFS)
Overall Survival (OS)
Overall Survival (OS)

Full Information

First Posted
October 14, 2020
Last Updated
February 27, 2021
Sponsor
iCell Gene Therapeutics
Collaborators
iCAR Bio Therapeutics Ltd., Peking University Shenzhen Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04594135
Brief Title
Anti-CD5 CAR T Cells for Relapsed/Refractory T Cell Malignancies
Acronym
CD5CAR-T
Official Title
Anti-CD5 CAR T Cells for Relapsed/Refractory T Cell Malignancies
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2020 (Actual)
Primary Completion Date
November 30, 2023 (Anticipated)
Study Completion Date
November 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
iCell Gene Therapeutics
Collaborators
iCAR Bio Therapeutics Ltd., Peking University Shenzhen Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
T-cell Acute Lymphoblastic Leukemia, T-cell Non-Hodgkin Lymphoma
Keywords
anti-CD5 CAR, T cell leukemia/lymphoma, T-ALL

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
anti-CD5 CAR T cells
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
anti-CD5 CAR T cells
Intervention Description
anti-CD5 CAR T cells transduced with a lentiviral vector to express CD5 chimeric receptor domain on T cells
Primary Outcome Measure Information:
Title
Number of adverse events after anti-CD5 CAR T cells cell infusion
Description
Determine the toxicity profile of anti-CD5 CAR T cell therapy
Time Frame
2 years particularly the first 28 days after infusion
Secondary Outcome Measure Information:
Title
Incidence of treatment-emergent adverse events
Description
Incidence of treatment-emergent adverse events
Time Frame
up to 6 months
Title
Disease Free Survival (DFS)
Description
Disease Free Survival (DFS)
Time Frame
up to 2 years
Title
Progression-Free Survival (PFS)
Description
Progression-Free Survival (PFS)
Time Frame
up to 2 years
Title
Overall Survival (OS)
Description
Overall Survival (OS)
Time Frame
up to 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kevin G Pinz, MS
Phone
6315386218
Email
kevin.pinz@icellgene.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hongyu Zhang, MD/PhD
Organizational Affiliation
Peking University Shenzhen Hospital, China
Official's Role
Principal Investigator
Facility Information:
Facility Name
Peking University Shenzhen Hospital
City
Shenzhen
State/Province
Guangdong
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hongyu Zhang, MD/PhD
Email
Hongyu.Zhang@pkuszh.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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