Back to resultsNon-gene Edited Anti-CD7 CAR T Cells for Relapsed/Refractory T Cell Malignances
Primary Purpose
T-cell Acute Lymphoblastic Leukemia, T-cell Acute Lymphoblastic Lymphoma, T-cell Non-Hodgkin Lymphoma
Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
CD7 CAR T cells
Sponsored by
About this trial
This is an interventional treatment trial for T-cell Acute Lymphoblastic Leukemia focused on measuring Anti-CD7 CAR, CD7CAR, T cell leukoma/lymphoma, T-ALL, T-cell acute lymphoblastic leukemia, T-cell acute lymphoblastic lymphoma
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
Sites / Locations
- Peking University Shenzhen HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
anti-CD7 CAR T cells
Arm Description
anti-CD7 CAR T cells Dose escalation phase: anti-CD7 CAR T cells transduced with a lentiviral vector to express CD7 chimeric receptor domain on T cells with an escalation approach, 1 e6 to 5 e6 CAR-T cells/kg.
Outcomes
Primary Outcome Measures
Dose limiting toxicity (DLT)
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
Type of dose-limiting toxicity (DLT)
Type of dose-limiting toxicity (DLT)
Adverse event by severity
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
Secondary Outcome Measures
Overall response rate of ant-CD7 CAR
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)
Progression-free survival (PFS)
Overall survival
Overall survival
Full Information
NCT ID
NCT04934774
First Posted
February 27, 2021
Last Updated
June 19, 2021
Sponsor
iCell Gene Therapeutics
Collaborators
iCAR Bio Therapeutics Ltd., Peking University Shenzhen Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04934774
Brief Title
Non-gene Edited Anti-CD7 CAR T Cells for Relapsed/Refractory T Cell Malignances
Official Title
Non-gene Edited Anti-CD7 CAR T Cells for Relapsed/Refractory T Cell Malignances
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Unknown status
Study Start Date
December 1, 2020 (Actual)
Primary Completion Date
June 1, 2023 (Anticipated)
Study Completion Date
June 1, 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 non-gene edited anti-CD7 CAR (also called anti-CD7 CAR) T cells in patients with relapsed and/or refractory T cell lymphoma or leukemia
Detailed Description
Anti-CD7 CAR is a chimeric antigen receptor immunotherapy treatment designed to treat leukemia/lymphoma expressing CD7 antigen. T-cell acute lymphoblastic leukemia, T-acute lymphoblastic lymphoma and T-cell non-Hodgkin lymphoma are a subset of leukemias and lymphomas that are positive for the surface protein CD7. The purpose of this study is to evaluate the efficacy and safety of anti-CD7 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 Acute Lymphoblastic Lymphoma, T-cell Non-Hodgkin Lymphoma
Keywords
Anti-CD7 CAR, CD7CAR, T cell leukoma/lymphoma, T-ALL, T-cell acute lymphoblastic leukemia, T-cell acute lymphoblastic lymphoma
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-CD7 CAR T cells
Arm Type
Experimental
Arm Description
anti-CD7 CAR T cells Dose escalation phase: anti-CD7 CAR T cells transduced with a lentiviral vector to express CD7 chimeric receptor domain on T cells with an escalation approach, 1 e6 to 5 e6 CAR-T cells/kg.
Intervention Type
Biological
Intervention Name(s)
CD7 CAR T cells
Intervention Description
Non-gene edited anti-CD7 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
Dose limiting toxicity (DLT)
Description
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
The first 28 days after infusion
Title
Type of dose-limiting toxicity (DLT)
Description
Type of dose-limiting toxicity (DLT)
Time Frame
The first 28 days after infusion
Title
Adverse event by severity
Description
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 Outcome Measure Information:
Title
Overall response rate of ant-CD7 CAR
Description
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
Time Frame
1 year
Title
Progression-free survival (PFS)
Description
Progression-free survival (PFS)
Time Frame
1 year
Title
Overall survival
Description
Overall survival
Time Frame
1 year
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
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
Non-gene Edited Anti-CD7 CAR T Cells for Relapsed/Refractory T Cell Malignances
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