drugset

drugset / Trial / NCT05840107

Study of FasT CAR-T GC012F Injection NDMM Patients

NCT05840107 ↗

Phase 0 Unknown 18 enrolled Shanghai Changzheng Hospital Gracell Biotechnologies (Shanghai) Co., Ltd. · collab

NaSingle-groupOpen-labelTreatment

Summary

This is a single-arm, single-center, open-label clinical study to evaluate the safety and efficacy of CAR-T in patients with NDMM.

Timeline

Start: 2023-05-04
Primary completion: 2025-09-30
Completion: 2025-09-30

Publications

Liu J, Fan X, Peng L, Liu J, He H, Qiang W, Jin L, Shi L, Lu J, Guo P, Shah N, Zhang Q, Shen L, Du J. BCMA/CD19 dual-targeting CAR T-cell therapy in older patients with newly diagnosed multiple myeloma: a phase 1 study. Blood Adv. 2026 Jun 23;10(12):4134-4143. doi: 10.1182/bloodadvances.2025019036.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	GC012F	Cell therapy	0.6 cells/kg	Intravenous
Subject	GC012F	Cell therapy	1.5 cells/kg	Intravenous
Subject	GC012F	Cell therapy	3 cells/kg	Intravenous

Indications