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.
Plain-language title generated from the registry record
Registry title: ASCT Combined With BCMA CAR-T and GPRC5D/CD3 BiTEs Maintenance for Transplant-Eligible Primary Plasma Cell Leukemia
Key facts
- Where
- Tianjin, ChinaSee the site
- Phase
- Phase 2
Could this be for you?
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?
Source: NCT07106684, who can take part
Where in China
- Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical SciencesTianjin, ChinaTaking people
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?
Trial details
- Who runs it
- Institute of Hematology & Blood Diseases Hospital, China
- Trial code
- NCT07106684
- Record updated
- 27 October 2026
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: 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.
Exclusion: 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.