Actively Recruiting
ASCT Combined With BCMA CAR-T and GPRC5D/CD3 BiTEs Maintenance for Transplant-Eligible Ultra-High-Risk Multiple Myeloma
Led by Institute of Hematology & Blood Diseases Hospital, China · Updated on 2025-08-06
30
Participants Needed
1
Research Sites
155 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a prospective, single-arm, phase II study to evaluate the efficacy and safety of autologous stem cell transplantation combined with BCMA CAR-T therapy followed by GPRC5D/CD3 bispecific antibody maintenance in transplant-eligible patients with ultra-high-risk multiple myeloma.
CONDITIONS
Official Title
ASCT Combined With BCMA CAR-T and GPRC5D/CD3 BiTEs Maintenance for Transplant-Eligible Ultra-High-Risk Multiple Myeloma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 70 years.
- Newly diagnosed multiple myeloma according to IMWG criteria.
- Measurable disease defined by serum or urine M-protein levels or abnormal serum free-light chain levels.
- Eligible for high-dose chemotherapy with autologous stem cell transplantation.
- Presence of at least one ultra-high-risk feature: double-hit multiple myeloma (with specified cytogenetic abnormalities), extramedullary soft tissue plasmacytomas, or circulating plasma cells 2% or higher.
- Tumor cells positive for BCMA and GPRC5D.
- Serum total bilirubin less than 2 times upper limit of normal, AST and ALT less than 3 times upper limit of normal, and creatinine clearance 30 mL/min or higher.
- Ability and willingness to provide written informed consent.
You will not qualify if you...
- Active amyloidosis.
- Central nervous system involvement.
- Prior BCMA-targeted therapy or CAR-T therapy.
- Active hepatitis B or C infection.
- Known HIV infection.
- Life expectancy less than 6 months.
- Pregnant or breastfeeding women.
- Uncontrolled dysfunction of heart, lung, brain, or other important organs.
- Any other conditions deemed unsuitable for the trial by the principal investigator.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical Sciences
Tianjin, Tianjin Municipality, China, 300020
Actively Recruiting
Research Team
G
Gang An, PhD&MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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