- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04594135
Anti-CD5 CAR T Cells for Relapsed/Refractory T Cell Malignancies (CD5CAR-T)
February 27, 2021 updated by: iCell Gene Therapeutics
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.
Study Overview
Status
Recruiting
Intervention / Treatment
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 Type
Interventional
Enrollment (Anticipated)
20
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Kevin G Pinz, MS
- Phone Number: 6315386218
- Email: kevin.pinz@icellgene.com
Study Locations
-
-
Guangdong
-
Shenzhen, Guangdong, China
- Recruiting
- Peking University Shenzhen Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
6 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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
|
anti-CD5 CAR T cells transduced with a lentiviral vector to express CD5 chimeric receptor domain on T cells
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of adverse events after anti-CD5 CAR T cells cell infusion
Time Frame: 2 years particularly the first 28 days after infusion
|
Determine the toxicity profile of anti-CD5 CAR T cell therapy
|
2 years particularly the first 28 days after infusion
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of treatment-emergent adverse events
Time Frame: up to 6 months
|
Incidence of treatment-emergent adverse events
|
up to 6 months
|
Disease Free Survival (DFS)
Time Frame: up to 2 years
|
Disease Free Survival (DFS)
|
up to 2 years
|
Progression-Free Survival (PFS)
Time Frame: up to 2 years
|
Progression-Free Survival (PFS)
|
up to 2 years
|
Overall Survival (OS)
Time Frame: up to 2 years
|
Overall Survival (OS)
|
up to 2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 1, 2020
Primary Completion (Anticipated)
November 30, 2023
Study Completion (Anticipated)
November 30, 2023
Study Registration Dates
First Submitted
October 14, 2020
First Submitted That Met QC Criteria
October 14, 2020
First Posted (Actual)
October 20, 2020
Study Record Updates
Last Update Posted (Actual)
March 2, 2021
Last Update Submitted That Met QC Criteria
February 27, 2021
Last Verified
February 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Lymphoma, Non-Hodgkin
- Leukemia, Lymphoid
- Leukemia
- Lymphoma
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
- Lymphoma, T-Cell
- Precursor T-Cell Lymphoblastic Leukemia-Lymphoma
Other Study ID Numbers
- ICG190-001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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