Stem cell transplant, CAR-T and antibody maintenance for primary plasma cell leukemia
Tests transplant, CAR-T and antibody therapy in adults with primary plasma cell leukemia.
Key facts
- Who runs it
- Institute of Hematology & Blood Diseases Hospital, China
- Where
- Tianjin, ChinaSee the site
- Trial code
- Registry title
- ASCT Combined With BCMA CAR-T and GPRC5D/CD3 BiTEs Maintenance for Transplant-Eligible Primary Plasma Cell Leukemia
- Status
- Recruiting
- Phase
- Phase 2
- People taking part
- 20 people, planned
- Started
- 9 Aug 2025
- Expected to end
- 1 Aug 2029
- Type of study
- Interventional
- Treatments tested
- Autologous hematopoietic stem cell transplantation
- BCMA CAR-T
- GPRC5D/CD3 BiTEs
- Record updated
- 27 October 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults aged 18 to 70 with newly diagnosed primary plasma cell leukemia who can have high-dose chemotherapy with an autologous stem cell transplant.
- Age
- 18 to 70 years
- Sex
- All sexes can join.
- Disease stage
- Newly diagnosed primary plasma cell leukemia with measurable disease (serum M-protein ≥1.0 g/dL, or urine M-protein ≥200 mg/24 hours, or serum free light chain ≥10 mg/dL with an abnormal kappa/lambda ratio).
- Earlier treatment
- People who had earlier BCMA-targeted therapy or CAR-T therapy cannot join.
- Biomarker or test result
- Tumor cells must be BCMA positive and GPRC5D positive.
Main reasons for not taking part
- Active amyloidosis
- Central nervous system involvement
- Prior BCMA-targeted therapy or CAR-T therapy
- Active hepatitis B or hepatitis C infection, or known HIV infection
- Pregnant or breastfeeding women
The registry criteria, word for word
Show all 16 criteriaShow less
Who can take part
- Age ≥ 18 years and ≤ 70 years
- Participants with documented newly-diagnosed primary plasma cell leukemia according to IMWG diagnostic criteria
- Measurable disease at screening, defined as: Serum M-protein level ≥1.0 g/dL or urine M-protein level ≥200 mg/24 hours; or Light chain MM without measurable disease in serum or urine: serum Ig free-light chain (FLC) ≥10 mg/dL and abnormal serum Ig kappa lambda FLC ratio
- Patients deemed eligible for high-dose chemotherapy with ASCT
- Tumor cells were BCMA and GPRC5D positive
- Serum total bilirubin <2 x upper limit of normal (ULN), serum AST and ALT <3 x ULN, creatinine clearance ≥ 30mL/min (Cockroft-Gault formula)
- Informed Consent/Assent: All subjects have the ability to understand and the willingness to sign a written informed consent
Who cannot take part
- Prior BCMA-targeted therapy or CAR-T therapy
- Active hepatitis B or hepatitis C virus infection
- Known HIV infection
- Evidence of uncontrolled dysfunction of heart, lung, brain, and other important organs
- Any other conditions that are not eligible for the trial in the judgement of the principal investigator
- Active amyloidosis
- Central nervous system involvement
- Life expectancy <6 months
- Woman who are pregnant or breastfeeding
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 70 years old?
Where in China
- Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical SciencesTianjin, ChinaContact: Gang AnTaking people
About the trial
What the trial wants to find out
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.
The group in the trial
- ASCT Combined With BCMA CAR-T and GPRC5D/CD3 BiTEs MaintenanceTreatment being tested
Patients will receive induction therapy, undergo ASCT followed by BCMA CAR-T infusion. Three month after CAR-T cell infusion, patients will begin GPRC5D/CD3 BiTEs maintenance therapy.
Treatment: Autologous hematopoietic stem cell transplantation, BCMA CAR-T, and GPRC5D/CD3 BiTEs
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- A Prospective, Single-Arm, Phase II Study 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
- Plain-language title
- Stem cell transplant, CAR-T and antibody maintenance for primary plasma cell leukemiaGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Fit questions
- Built from NCT07106684, who can take part
- Record updated
- 27 October 2026