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
- FasT CAR-19 (GC007F) can be manufactured overnight with 100% success
- FasT CAR-19 is expected to be a best-in-class therapy for relapsed or refractory B-ALL.
Gracell Biotechnologies Co., Ltd. ("Gracell"), a clinical-stage cellular immunotherapy company, today announced preliminary results of a multi-center pilot study designed for evaluating the safety and efficacy of Gracell's patented FasT CAR-19 (GC007F) investigational cell gene therapy. The customized treatment which genetically modifies patient's T-cells to express CD19-specific chimeric antigen receptor (CAR), showed a clinically meaningful and positive result in the treatment of B-cell acute lymphoblastic leukemia (B-ALL). The results of the study were announced during the CAR-TCR Summit Asia, held June 18-20, 2019 in Shanghai.
B-ALL is a sub-type of ALL, a cancer of the lymphoid line of blood cells. For a vast number of patients, B-ALL can be treated by chemotherapy and stem cell transplant. However, for the many patients who develop relapsed or refractory (r/r) B-ALL, significant complications in treatment remain. With characteristically low life expectancy, r/r B-ALL is one of the most devastating forms of malignancies. Anti-CD19 CAR-T products have been developed specifically for these late-stage patients.
Currently approved anti-CD19 CAR-T bioprocessing takes on average two weeks to manufacture and seven days to pass quality test. With Gracell's FasT CAR solution, preparation time can be cut to 24 hours, significantly reducing production cost and waiting time. In addition, FasT CAR can be administered vein-to-vein (time from when cells are extracted to when they are infused back into the patient) within seven days after leukapheresis, providing substantial meaning and significant benefitto physicians and patients.
With a manufacturing success rate of 19/19 (100%) without patient loss, FasT CAR-19 cells are considered much more potent and durable in comparison to currently available alternatives. With these advantages, FasT CAR-19 is highly cost-effective and has considerable potential to establish a new standard in CAR-T treatment for r/r B-ALL.
The multi-center investigational study enrolled 19 adolescent and adult patients aged from 14 to 70 years, who suffered from relapsed or refractory B-ALL and had failed to respond to multiple prior lines of therapy. As of June 12, all patients received a single infusion of FasT CAR-19 following lymphodepleting chemotherapy. FasT CAR-19 was administered at three dose levels from low to high, equivalent to 1/30-1/10 of the standard CAR-T therapy dose, respectively.
The treatment efficacy was assessed in 16 patients, of which:
- 16 (100%) achieved complete remission with or without complete blood count recovery (CR/CRi);
- 14 (87%) achieved undetectable minimal residual disease (uMRD) (< 10-4 detectable leukemic cells in bone marrow);
- 15 (94%) experienced an ongoing response by June 12. Notably, one adolescent patient achieved CR and uMRD after 28 days of regular follow-up treatment, turned MRD positive at week 12, and converted back to uMRD again at week 20 with the ongoing response status remaining up to June 12.
During the over six month-durable remission period, FasT CAR-19 demonstrated a good level of persistence. In terms of safety, all 19 patients tolerated the single infusion of FasT CAR-19 at different dose levels, with no dose-limiting toxicities observed. The most common safety concerns were cyt...
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