Ignite Creation Date:
2025-12-25 @ 2:17 AM
Ignite Modification Date:
2025-12-30 @ 7:50 AM
Study NCT ID:
NCT07070960
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-07-17
First Post:
2025-07-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of Anti-BCMA CAR-T Therapy in Newly Diagnosed Myeloma Patients Who Are Transplant-ineligible
Sponsor:
Xuzhou Medical University
Organization:
Study Overview
Official Title:
A Multicenter, Open-label, Single-arm Clinical Study of Anti-BCMA CAR-T Cell Therapy in Transplant-ineligible Patients With Newly Diagnosed Multiple Myeloma
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-07
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:
CAR-T
Brief Summary:
This is a prospective study of anti-BCMA CAR-T in transplant-ineligible patients with newly diagnosed multiple myeloma.
Detailed Description:
After the diagnosis of multiple myeloma (MM), patients were stratified by frailty status. Frail patients received 4 cycles of VRd regimen (bortezomib, lenalidomide, and dexamethasone), while non-frail patients received 4 cycles of DVRd regimen (daratumumab, bortezomib, lenalidomide, and dexamethasone). Following induction therapy, peripheral blood lymphocytes were collected to manufacture anti-BCMA CAR-T cells. After lymphodepletion with the FC regimen (fludarabine and cyclophosphamide), patients received a single infusion of anti-BCMA CAR-T cells at a target dose of 2.0 × 10\^6 CAR-positive cells per kilogram of body weight. Peripheral blood samples were collected at regular intervals to assess treatment efficacy, safety, and CAR-T cell expansion and persistence. Patients were closely monitored for 6 months post-infusion. Thereafter, disease assessments, physical examinations, and hematologic tests were conducted every 3 months for a total follow-up duration of 2 years.
Study Oversight
Has Oversight DMC:
False
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?: