Actively Recruiting
Safety and Efficiency of VRd Combining BCMA CAR-T Regimen for Transplant-ineligible Patients With Primary Plasma Cell Leukemia: a Prospective, Single-arm, Single-center, Phase II Study
Led by Institute of Hematology & Blood Diseases Hospital, China · Updated on 2025-08-03
20
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of a combination treatment involving a VRD-based regimen and BCMA CAR-T therapy for patients with primary plasma cell leukemia who are not eligible for transplant. This phase II, single-arm, open-label study aims to assess outcomes in this specific patient group at a single center, focusing on key measures such as safety and the rate of minimal residual disease negativity after consolidation treatment. Participants receive three courses of induction therapy with the VRD-based regimen, consisting of Bortezomib, Lenalidomide, and Dexamethasone administered in a 28-day cycle. This is followed by an intravenous infusion of autologous BCMA-directed CAR-T cells at a targeted dose. After the CAR-T infusion, patients undergo three courses of VR consolidation therapy and then continue with VR maintenance therapy. Throughout the study, participants will be closely monitored with evaluations including safety and tolerability assessments up to two years, and measurement of minimal residual disease negativity shortly after consolidation therapy. Additional outcomes include complete response rates at various time points, progression-free survival up to two years, overall survival up to five years, and duration of remission. The total study duration and follow-up periods allow for comprehensive assessment of treatment effects and patient outcomes.
CONDITIONS
Brief Title
A Study of Bortezomib, Lenalidomide and Dexamethasone (VRd)-Based Regimen Followed by BCMA CAR-T Therapy in Transplant-Ineligible Patients With Primary Plasma Cell Leukemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years and older, up to 75 years.
- Documented primary plasma cell leukemia per IMWG criteria.
- Measurable disease defined by specified protein levels in serum or urine.
- Not eligible for high-dose chemotherapy with stem cell transplant due to age, health status, or other factors.
- Bone marrow sample confirmed BCMA-positive.
- Screening blood tests within protocol limits including liver, kidney, and blood cell counts.
- Able to take recommended prophylactic anticoagulant therapy.
- Women must not be breastfeeding or pregnant and agree to avoid pregnancy during and 12 months after the study; men agree that their partners avoid pregnancy during this time.
You will not qualify if you...
- Active amyloidosis.
- Central nervous system involvement.
- Prior BCMA-targeted or CAR-T therapy.
- Peripheral neuropathy greater than grade 2 or with pain.
- Known intolerance or allergy to study drugs or CAR-T products.
- HIV positive.
- Hepatitis B or C infection.
- Life expectancy less than 6 months.
- Pregnant or breastfeeding women.
- Active gastrointestinal problems affecting medication intake.
- Recent major surgery or not fully recovered.
- Live attenuated vaccine within 4 weeks prior to treatment.
- Serious mental or medical illness affecting consent or participation.
- Contraindicated medications or therapies.
- Other diseases or complications interfering with the study.
- Unwilling or unable to comply with the study protocol.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
screening and enrollment visit
Duration - Approximately several months over multiple treatment cycles
Participants receive 3 courses of induction therapy with the VRD-based regimen followed by infusion of BCMA CAR-T cells, then 3 courses of VR consolidation therapy, and finally VR maintenance therapy.
Multiple visits for induction, CAR-T infusion, consolidation, and maintenance therapy
Trial Site Locations
Total: 1 location
1
Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical Sciences
Tianjin, China
Actively Recruiting
Research Team
G
Gang An, PhD&MD
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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