Actively Recruiting
ASCT Combined With BCMA CAR-T and GPRC5D/CD3 BiTEs Maintenance for Transplant-Eligible Primary Plasma Cell Leukemia
Led by Institute of Hematology & Blood Diseases Hospital, China · Updated on 2025-08-06
20
Participants Needed
1
Research Sites
207 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 primary plasma cell leukemia.
CONDITIONS
Official Title
ASCT Combined With BCMA CAR-T and GPRC5D/CD3 BiTEs Maintenance for Transplant-Eligible Primary Plasma Cell Leukemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 70 years
- Newly diagnosed primary plasma cell leukemia based on IMWG criteria
- Measurable disease with serum M-protein ≥1.0 g/dL, urine M-protein ≥200 mg/24 hours, or specific light chain markers
- Eligible for high-dose chemotherapy with autologous stem cell transplantation
- Tumor cells positive for BCMA and GPRC5D
- Liver function: bilirubin less than 2 times upper limit of normal; AST and ALT less than 3 times upper limit of normal
- Kidney function: creatinine clearance at least 30 mL/min
- Ability and willingness to provide written informed consent
You will not qualify if you...
- Active amyloidosis
- Involvement of the central nervous system
- Previous treatment with 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 condition judged by the principal investigator as unsuitable for the study
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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