Clinical trial · Interventional
ASCT Combined With BCMA CAR-T and GPRC5D/CD3 BiTEs Maintenance for Transplant-Eligible Primary Plasma Cell Leukemia
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Multiple Myeloma, Plasma Cell Leukemia | Multiple Myeloma | CURATED_EXACT | 0.85 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Autologous hematopoietic stem cell transplantation | Procedure | — | UNRESOLVED |
| BCMA CAR-T | Biological | — | UNRESOLVED |
| GPRC5D/CD3 BiTEs | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- ASCT Combined With BCMA CAR-T and GPRC5D/CD3 BiTEs Maintenance
- description
- 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 for ≥2 years.
- interventionNames
- Procedure: Autologous hematopoietic stem cell transplantation
- Biological: BCMA CAR-T
- Drug: GPRC5D/CD3 BiTEs
Primary outcomes (2)
- measure
- Sustained MRD-negative rate
- timeFrame
- Up to 2 year
- description
- Rate of patients achieving sustained MRD negativity for more than 12 months
- measure
- MRD negativity rate
- timeFrame
- Up to 2 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age ≥ 18 years and ≤ 70 years. 2. Participants with documented newly-diagnosed primary plasma cell leukemia according to IMWG diagnostic criteria. 3. 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. 4. Patients deemed eligible for high-dose chemotherapy with ASCT. 5. Tumor cells were BCMA and GPRC5D positive. 6. Serum total bilirubin \<2 x upper limit of normal (ULN), serum AST and ALT \<3 x ULN, creatinine clearance ≥ 30mL/min (Cockroft-Gault formula). 7. Informed Consent/Assent: All subjects have the ability to understand and the willingness to sign a written informed consent. Exclusion Criteria: 1. Active amyloidosis. 2. Central nervous system involvement. 3. Prior BCMA-targeted therapy or CAR-T therapy. 4. Active hepatitis B or hepatitis C virus infection. 5. Known HIV infection. 6. Life expectancy \<6 months. 7. Woman who are pregnant or breastfeeding 8. Evidence of uncontrolled dysfunction of heart, lung, brain, and other important organs. 9. Any other conditions that are not eligible for the trial in the judgement of the principal investigator.
References
Publications (0)
Data not yet available