Safety and efficacy results of GC027: The first-in-human, universal CART cell therapy for adult relapsed/refractory T-cell acute lymphoblastic leukemia (r/r T-ALL).
Abstract No : 3013
Abstract Type : Poster Discussion Session
Indication : T-ALL
Intervention : GC027
Company : Gracell Biotechnologies Co., Ltd
Technology : CAR T cell therapy
Results:
As of Feb. 6, 2020, 5 pts had received a single dose of GC027, including 1 at 0.6x107/kg, 3 at 1x107/kg, 1 at 1.5x107/kg. 3 pts achieved MRD negative complete responses (MRD- CR) at D28 evaluation and remained MRD- at follow-up re-evaluations (161, D118, 61, respectively) without bridging to HSCT. 1 pt just achieved D28 MRD- CR at time of submission. 1 pt achieved MRD+ CR at D14, but his disease progressed at D29 and deceased due to relapse. In all 4 pts with MRD- CR, peak expansions of GC027 in peripheral blood were observed between week 1-2, analyzed by flow cytometry and Q-PCR. Grade 3 cytokine release syndrome (CRS) occurred in 4 pts and Grade 4 CRS occurred in 1 pt (ASBMT Consensus Grading). CRS symptoms were manageable and resolved after treatment and supportive care. None developed neurotoxicity or GvHD. One had prolonged cytopenia due to fungal infection and required anti-fungal therapy.
Conclusion:
With a single infusion of GC027, 80% of the patients had robust CAR-T cell expansion and achieved persistent MRD- CR without using any biologics as part of the preconditioning therapy or bridging to HSCT. The first-in-human, universal CAR-T therapy for r/r T-ALL, GC027 has demonstrated superior clinical efficacy and induced deep response in patients with acceptable safety profile. The trial enrollment is ongoing and updated data will be presented at the meeting.
Commentary:
GC027 T cell therapy shows encouraging early efficacy results with 100% response in first 5 patients.
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