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DRUG:

GC007F

i
Other names: GC007F, CD19 CAR-T cells, anti-CD19 CAR-T cell therapy, FasTCAR-19, anti-CD19 FasT CAR-T cells
Associations
Company:
AstraZeneca
Drug class:
CD19-targeted CAR-T immunotherapy
Related drugs:
Associations
almost2years
Novel CD19 chimeric antigen receptor T cells manufactured next-day for acute lymphoblastic leukemia. (PubMed, Blood Cancer J)
GC007F demonstrated superior expansion capacity and a less exhausted phenotype as compared to (C-CAR-T) cells. Moreover, this first-in-human clinical study showed that the novel, next-day manufacturing FasTCAR-T cells was feasible with a manageable toxicity profile in patients with R/R B-ALL.
Journal • CAR T-Cell Therapy
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CD19 (CD19 Molecule)
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GC007F
2years
A Study of GC007F CAR-T Cell Immunotherapy for Relapsed or Refractory B- ALL (clinicaltrials.gov)
P1, N=29, Completed, Hebei Yanda Ludaopei Hospital | Recruiting --> Completed | N=20 --> 29
Trial completion • Enrollment change • CAR T-Cell Therapy
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CD19 (CD19 Molecule)
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CD19 expression
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GC007F
over4years
A Bcma and CD19 Bispecific CAR-T for Relapsed and Refractory Multiple Myeloma (ASH 2019)
One patient did not receive lymphodepletion, and all other 4 patients received i.v. fludarabine and cyclophosphamide for 3 days...Bispecific CAR-T manufacturing on the FasT CAR-T platform is successful and has been shown to be more potent. A clinical study to evaluate safety and efficacy of FasT BCMA-CD19 CAR-T is ongoing.
IO biomarker
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CD8 (cluster of differentiation 8)
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fludarabine IV • GC007F
over4years
Anti-CD19/CD22 Dual CAR-T Therapy for Refractory and Relapsed B-Cell Acute Lymphoblastic Leukemia (ASH 2019)
All pts received conditioning regimen of fludarabine and cyclophosphamide intravenously for 3 consecutive days with doses of 30 mg/m2/day and 250 mg/m2/day, respectively before a single infusion of CAR-T cells...A low toxicity with dose-dependent high CR rate including pts who previously treated with CD19 CAR-T cells were observed. Longer observation time and more patients are needed to evaluate a beneficial advantage of the CD19/CD22 dual CAR-T over CD19 CAR-T product.
IO biomarker
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IFNG (Interferon, gamma) • IL6 (Interleukin 6) • IL2RA (Interleukin 2 receptor, alpha) • IL10 (Interleukin 10)
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fludarabine IV • GC007F • SENL-B19