Non-gene Edited Anti-CD7 CAR T Cells for Relapsed/Refractory T Cell Malignances
1 other identifier
interventional
20
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Dec 2020
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2020
CompletedFirst Submitted
Initial submission to the registry
February 27, 2021
CompletedFirst Posted
Study publicly available on registry
June 22, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2023
CompletedJune 22, 2021
June 1, 2021
2.5 years
February 27, 2021
June 19, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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
The first 28 days after infusion
Type of dose-limiting toxicity (DLT)
Type of dose-limiting toxicity (DLT)
The first 28 days after infusion
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
2 years
Secondary Outcomes (3)
Overall response rate of ant-CD7 CAR
1 year
Progression-free survival (PFS)
1 year
Overall survival
1 year
Study Arms (1)
anti-CD7 CAR T cells
EXPERIMENTALanti-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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- iCell Gene Therapeuticslead
- iCAR Bio Therapeutics Ltd.collaborator
- Peking University Shenzhen Hospitalcollaborator
Study Sites (1)
Peking University Shenzhen Hospital
Shenzhen, Guangdong, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hongyu Zhang
Peking University Shenzhen Hospital, China
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 27, 2021
First Posted
June 22, 2021
Study Start
December 1, 2020
Primary Completion
June 1, 2023
Study Completion
June 1, 2023
Last Updated
June 22, 2021
Record last verified: 2021-06
Data Sharing
- IPD Sharing
- Will not share