Study of FasT CAR-T GC012F Injection in High Risk TE NDMM Patients

Multiple Myeloma Clinical Trial

Official title: Frontline Therapy of GC012F Injection in Transplant Eligible Newly Diagnosed Multiple Myeloma Patients With High-Risk Profile

Status Recruiting

Clinical Trial Summary

This is a single-arm, single-center, open-label clinical study to evaluate the safety and efficacy of GC012F in high-risk, transplant eligible patients with NDMM.

Clinical Trial Description

Twenty 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 GC012F, and the efficacy assessments will be performed at 1 month, 3 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 and 3rd months after infusion:

1. <PR: Protocol change or transplantation or follow-up decided by the investigator.

2. ≥PR: MRD positive: Protocol change or transplantation or follow-up decided by the investigator.

MRD negative: Wait for next follow-up.

2.Efficacy assessments performed at the 6th month after infusion and every 3 months thereafter:

1. MRD positive: Protocol change or transplantation or follow-up decided by the investigator.

2. MRD negative: Whether to carry out maintenance treatment using lenalidomide until the end of the trial will be determined by the investigator.

After signing the informed consent form (ICF), subjects will be followed up for efficacy and safety until 2 years after GC012F 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 GC012F 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 GC012F infusion, survival follow-up will be also performed as described above. ;

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

• NCT number: NCT04935580
• Study type: Interventional
• Source: Shanghai Changzheng Hospital
• Contact: Juan Du, MD
• Phone: +86-21-81885423
• Email: changzheng_pg@163.com
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: June 28, 2021
• Completion date: July 1, 2023