Ignite Creation Date:
2024-05-06 @ 6:58 PM
Last Modification Date:
2024-10-26 @ 2:57 PM
Study NCT ID:
NCT05840107
Status:
RECRUITING
Last Update Posted:
2024-02-13
First Post:
2023-04-22
Brief Title:
Study of FasT CAR-T GC012F Injection NDMM Patients
Sponsor:
Shanghai Changzheng Hospital
Organization:
Shanghai Changzheng Hospital
Study Overview
Official Title:
CAR-T Injection in Transplant In-Eligible Newly Diagnosed Multiple Myeloma Patients
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 patients 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
1Efficacy assessments performed at the 1st month after infusion
1 PR Protocol change or follow-up decided by the investigator
2 PR Follow-up
2Efficacy 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 weeks14 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
1Efficacy assessments performed at the 1st month after infusion
1 PR Protocol change or follow-up decided by the investigator
2 PR Follow-up
2Efficacy 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 weeks14 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None