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Recruiting Phase 2

ASCT Combined With BCMA CAR-T and GPRC5D/CD3 BiTEs Maintenance for Transplant-Eligible Ultra-High-Risk Multiple Myeloma

NCT07106710 · tracked via the Priya Life Science China tracker
Phase
Phase 2
Started
2025-08-15
Last updated
2026-10-27

Condition(s) studied

Multiple Myeloma, Newly Diagnosed

Investigational drug(s) / intervention(s)

Autologous Hematopoietic Stem Cell TransplantationBCMA CAR-T →GPRC5D/CD3 BiTEs →

Autologous Hematopoietic Stem Cell Transplantation: Patients receive transplantation conditioning followed by autologous hematopoietic stem cell transplantation after successful stem cell mobilization and collection.

BCMA CAR-T: Patients will receive BCMA CAR-T single dose infusion 3 days after ASCT.

GPRC5D/CD3 BiTEs: Patients will receive GPRC5D/CD3 BiTEs maintenance therapy at a dose of 54 μg/kg every 4 weeks, starting 3 months after BCMA CAR-T infusion.

Study summary

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 ultra-high-risk multiple myeloma.

Eligibility

Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
Inclusion Criteria: 1. Age ≥ 18 years and ≤ 70 years. 2. Participants with documented newly-diagnosed multiple myeloma 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. Presence of at least one of the following ultra-high-risk features: a. Double-hit multiple myeloma, defined as the presence of at least two of the following high-risk cytogenetic abnormalities: t(4;14), t(14;16), deletion 1p, gain 1q, MYC rearrangement, deletion 17p, or TP53 mutation; b. Presence of extramedullary soft tissue plasmacytomas; c. Circulating plasma cells ≥2% in peripheral blood. 6. Tumor cells were BCMA and GPRC5D positive. 7. Serum total bilirubin \<2 x upper limit of normal (ULN), serum AST and ALT \<3 x ULN, creatinine clearance ≥ 30mL/min (Cockroft-Gault formula). 8. 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.

Primary outcome measure(s)

  • Sustained MRD-negative rate — Up to 2 year
    Rate of patients achieving sustained MRD negativity for more than 12 months
  • MRD negativity rate — Up to 2 years
    Rate of patients achieving MRD negativity

Trial sites (1)

FacilityCityRegionStatus
Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical Sciences Tianjin Tianjin Municipality Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07106710 on ClinicalTrials.gov ↗ ← All trials in China