A Study of GC007F CAR-T Cell Immunotherapy for Relapsed or Refractory B- ALL
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|ClinicalTrials.gov Identifier: NCT03825718|
Recruitment Status : Recruiting
First Posted : January 31, 2019
Last Update Posted : January 31, 2019
|Condition or disease||Intervention/treatment||Phase|
|B-cell Acute Lymphoblastic Leukemia||Biological: GC007F||Early Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Study of GC007F CAR-T Cell Immunotherapy for Relapsed or Refractory B- ALL|
|Actual Study Start Date :||January 17, 2019|
|Estimated Primary Completion Date :||September 16, 2019|
|Estimated Study Completion Date :||September 16, 2019|
Experimental: CAR-T treatment group
The patients will receive one dose of GC007F. GC007F dosage ranges from 6×10^4 to 2×10^6 CAR+T/Kg.
GC007F is the CAR-T cell immunotherapy targeted CD19. The subjects will receive GC007F as one dose. The dosage ranges from 6×10^4 to 2×10^6 CAR+T/Kg.
- Number of Patients with Dose Limiting Toxicity [ Time Frame: 12 weeks ]A dose limiting toxicity is defined as any toxicity that is considered to be primarily related to the GC007F cells, which is irreversible, or life threatening or hematologic or non-hematologic Grade 3-5
- Incidence and severity of adverse events [ Time Frame: 12 weeks ]After GC007F infusion, adverse events will be graded as CTCAE 4.0
- GC007F persistence [ Time Frame: 12 weeks ]After GC007F infusion, GC007F CAR copies in peripheral blood. bone marrow and CSF will be measured by qPCR in 12 weeks
- Percents of Patients with best response as complete remission and MRD negative complete remission. [ Time Frame: 12 weeks ]Response rates will be estimated as the percents of patients whose best response is complete remission and MRD negative complete remission.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03825718
|Hebei Yanda Ludaopei Hospital||Recruiting|
|Sanhe, Hebei, China, 065200|
|Contact: Peihua Lu, PhD&MD +86-0316-3306393 Peihua_lu@126.com|