NCT05840107

Study of FasT CAR-T GC012F Injection NDMM Patients

CAR-T Injection in Transplant In-Eligible Newly Diagnosed Multiple Myeloma Patients

• Status: Unknown
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 18 (estimated)
• Sponsor: Shanghai Changzheng Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

9-18 evaluable subjects are planned to be enrolled in this study. Apheresis will be carried out in subjects who meet eligible criteria, and total 2 cycles of induction therapy (three-drug combination regimen based on bortezomib with details determined by the investigator according to the patient's condition) will be selectively given to subjects before or after apheresis. Next, subjects will receive a single infusion of CAR-T, and the efficacy assessments will be performed at 1st month, 3rd months, and every 3 months within 2 years until the end of the trial (MRD testing is required for each efficacy assessment) 1.Efficacy assessments performed at the 1st month after infusion: 1. \<PR: Protocol change or follow-up decided by the investigator. 2. ≥PR: Follow-up. 2.Efficacy assessments performed at the 3rd month after infusion and every 3 months thereafter: 1. \<VGPR: Protocol change or follow-up decided by the investigator. 2. ≥VGPR: Maintenance treatment using lenalidomide until progress disease or clinical trial intolerance or termination of trial. After signing the informed consent form (ICF), subjects will be followed up for efficacy and safety until 2 years after CAR-T infusion, or disease progression, or death, or withdrawal of consent, or any intolerable toxicity, whichever comes first. All AEs in subjects, especially infection related symptoms and signs, will be closely monitored during follow-up, and prophylactic treatment will be administered according to clinical practice when necessary. In case of disease progression within 2 years after CAR-T infusion, treatment will be administered according to clinical practice, and the survival follow-up (only for the survival status) will be performed every 12 weeks±14 days (2 weeks) until 2 years after infusion, or death, or withdrawal of consent, whichever comes first. For subjects who have undergone transportation or any other clinical routine treatments after CAR-T infusion, survival follow-up will be also performed as described above.

Conditions

• Multiple Myeloma

Interventions

Type	Name	Description
BIOLOGICAL	GC012F injection	GC012F injection is an autologous dual CAR-T targeted BCMA and CD19. A single infusion of CAR-T cells will be administered intravenously

Timeline

• Start date: 2023-05-04
• Primary completion: 2025-09-30
• Completion: 2025-09-30
• First posted: 2023-05-03
• Last updated: 2024-02-13

Locations

1 site across 1 country: China