Non-gene Edited Anti-CD7 CAR T Cells for Relapsed/Refractory T Cell Malignances
NCT ID: NCT04934774
Last Updated: 2021-06-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1
20 participants
INTERVENTIONAL
2020-12-01
2023-06-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SEQUENTIAL
TREATMENT
NONE
Study Groups
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anti-CD7 CAR T cells
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.
CD7 CAR T cells
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.
Interventions
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CD7 CAR T cells
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
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Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
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iCAR Bio Therapeutics Ltd.
INDUSTRY
Peking University Shenzhen Hospital
OTHER
iCell Gene Therapeutics
INDUSTRY
Responsible Party
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Principal Investigators
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Hongyu Zhang
Role: PRINCIPAL_INVESTIGATOR
Peking University Shenzhen Hospital, China
Locations
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Peking University Shenzhen Hospital
Shenzhen, Guangdong, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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ICG177-001
Identifier Type: -
Identifier Source: org_study_id
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