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

Primary Purpose

T Cell Lymphoma in Relapse, Refractory T-Cell Lymphoma

Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
CD4 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 Lymphoma in Relapse focused on measuring CD4-specific CAR T, T cell leukemia, T cell lymphoma, CD4CAR

Eligibility Criteria

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

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

Sites / Locations

  • Peking University Shenzhen HospitalRecruiting
  • Chengdu Military General Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

CD4 CAR T cells

Arm Description

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

Outcomes

Primary Outcome Measures

Number of adverse events after CD4 CAR T cells cell infusion
Determine the toxicity profile of CD4 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) (IMWG criteria)
Progression-Free Survival (PFS)
Progression-Free Survival (IMWG criteria)
Overall Survival (OS)
overall survival

Full Information

First Posted
November 11, 2019
Last Updated
May 17, 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
NCT04162340
Brief Title
CD4-specific CAR T Cells (CD4 CAR T Cells) for Relapsed/Refractory T Cell Malignancies
Official Title
CD4-specific CAR T Cells (CD4 CAR T Cells) for Relapsed/Refractory T Cell Malignancies
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Unknown status
Study Start Date
July 11, 2019 (Actual)
Primary Completion Date
October 2021 (Anticipated)
Study Completion Date
October 2021 (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 CD4 CAR T cells in patients with relapsed and/or refractory T cell lymphoma.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
T Cell Lymphoma in Relapse, Refractory T-Cell Lymphoma
Keywords
CD4-specific CAR T, T cell leukemia, T cell lymphoma, CD4CAR

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
CD4 CAR T cells
Arm Type
Experimental
Arm Description
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
Intervention Type
Biological
Intervention Name(s)
CD4 CAR T cells
Intervention Description
CD4 CAR T cells administered to patients, will be either fresh or thawed CAR T cells by IV injection after receiving lymphodepleting chemotherapy.
Primary Outcome Measure Information:
Title
Number of adverse events after CD4 CAR T cells cell infusion
Description
Determine the toxicity profile of CD4 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) (IMWG criteria)
Time Frame
up to 2 years
Title
Progression-Free Survival (PFS)
Description
Progression-Free Survival (IMWG criteria)
Time Frame
up to 2 years
Title
Overall Survival (OS)
Description
overall survival
Time Frame
up to 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 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 Pinz, MS
Phone
6315386218
Email
kevin.pinz@icellgene.com
First Name & Middle Initial & Last Name or Official Title & Degree
Yupo Ma, MD/PhD
Phone
7024658132
Email
yupo.ma@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
First Name & Middle Initial & Last Name & Degree
Fang Liu, MD/PhD
Organizational Affiliation
Chengdu Military Hospital
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
Facility Name
Chengdu Military General Hospital
City
Chengdu
State/Province
Sichuan
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fang Liu, MD/PhD
Email
lfyh2006@yahoo.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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