CD19 CARvac T Cells for Patients With Relapsed / Refractory B Cell Malignancies
NCT ID: NCT04156243
Last Updated: 2019-11-12
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
EARLY_PHASE1
20 participants
INTERVENTIONAL
2018-02-01
2020-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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CD19 CARvac T cells
CD19 CARvac T cells transduced with a lentiviral vector to express
CD19 CARvac T cells
CD19 CARvac 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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CD19 CARvac T cells
CD19 CARvac 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. Patients have exhausted standard therapeutic options
3. Systematic usage of immunosuppressive drug or corticosteroid must have been stopped for more than 4 weeks
4. Female must be not pregnant during the study
Exclusion Criteria
2. Potentially curative therapy including chemotherapy or hematopoietic cell transplant
3. Prior treatment with BCMAxCD3 or CS1xCD3 bispecific agents
ALL
No
Sponsors
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Peking University Shenzhen Hospital
OTHER
Chengdu Military General Hospital
OTHER
iCAR Bio Therapeutics Ltd.
INDUSTRY
iCell Gene Therapeutics
INDUSTRY
Responsible Party
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Principal Investigators
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Hongyu Zhang, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Peking University Shenzhen Hospital
Fang Liu, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
The General Hospital of Western Theater Command
Locations
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The General Hospital of Western Theater Command
Chengdu, , China
Peking University Shenzhen Hospital
Shenzhen, , China
Countries
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Central Contacts
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Facility Contacts
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Fang Liu, MD, PhD
Role: primary
Role: backup
Hongyu Zhang, MD, PhD
Role: primary
Role: backup
References
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Liu F, Sha S, Ma G, Su Y, Xiong Y, He G, Li Y, Hanes WM, Tse W. Treatment of CML-transformed B Cell Acute Lymphoblastic Leukemia (B-ALL) in Adults with Anti-CD19 Chimeric Antigen Receptor T Cell (CAR T) Therapy. Stem Cell Rev Rep. 2020 Dec;16(6):1356-1358. doi: 10.1007/s12015-020-10008-7. No abstract available.
Other Identifiers
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ICG134-001
Identifier Type: -
Identifier Source: org_study_id
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