Drugs / GC007F
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 0 | NCT03825718 | Jan 2019 → Sep 2020 | B-cell acute lymphoblastic leukemia | Hebei Yanda Ludaopei Hospital | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 3
| Date | Issuer | Release |
|---|---|---|
| 2019-12-09 | Gracell Biotechnologies (Shanghai) Co., Ltd. | Results Gracell Announces Progressive Outcomes from Multiple Human Clinical Trials to Investigate FasTCAR and Dual CAR Cell Platform Technologies gracellbio.com ↗
FasTCAR-19 (GC007F) shows a high response rate, with 34 of 35 evaluable r/r B-ALL patients achieving CR on Day 28, where 32 patients achieving MRD negative CR |
| 2019-09-11 | Gracell Biotechnologies (Shanghai) Co., Ltd. | Results Gracell Announces Interim Readout of Investigation for First-in-class FasT CAR-19 in patients with Relapsed or Refractory B-cell Acute Lymphoblastic Leukemia and Extension in Use of FasT CAR to Other Immune Cell Programs gracellbio.com ↗
The study shows a high response rate, with 23 of 24 treated patients achieving complete remission and 21 of 24 treated patients achieving undetectable minimal residual disease on 28 days of follow-up |
| 2019-06-20 | Gracell Biotechnologies (Shanghai) Co., Ltd. | Results Gracell Data on Multi-center Investigation of FasT CAR-19 Therapy Shows Positive First Impact in Patients with Relapsed or Refractory B-cell Acute Lymphoblastic Leukemia gracellbio.com ↗
Preliminary data shows a high response rate, with 16 of 16 patients achieving complete remission and 14 of 16 patients achieving undetectable minimal residual disease with mild side effect observed |
All press releases naming this drug 3 releases
| Date | Issuer | Release |
|---|---|---|
| 2019-12-09 | Gracell Biotechnologies (Shanghai) Co., Ltd. | Gracell Announces Progressive Outcomes from Multiple Human Clinical Trials to Investigate FasTCAR and Dual CAR Cell Platform Technologies gracellbio.com ↗ |
| 2019-09-11 | Gracell Biotechnologies (Shanghai) Co., Ltd. | Gracell Announces Interim Readout of Investigation for First-in-class FasT CAR-19 in patients with Relapsed or Refractory B-cell Acute Lymphoblastic Leukemia and Extension in Use of FasT CAR to Other Immune Cell Programs gracellbio.com ↗ |
| 2019-06-20 | Gracell Biotechnologies (Shanghai) Co., Ltd. | Gracell Data on Multi-center Investigation of FasT CAR-19 Therapy Shows Positive First Impact in Patients with Relapsed or Refractory B-cell Acute Lymphoblastic Leukemia gracellbio.com ↗ |
Evidence & citations 2 cited values
Every value below carries the sentence it was read from. 1 source stands behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | GC007F | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03825718 ↗ |
| Modality | Cell therapy | “CAR-T cell immunotherapy” NCT03825718 ↗ |