High‑dose transplant with BCMA CAR‑T followed by GPRC5D/CD3 bispecific antibody maintenance for ultra‑high‑risk newly diagnosed multiple myeloma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, single‑arm phase II protocol for transplant‑eligible adults with newly diagnosed ultra‑high‑risk multiple myeloma. After up to four cycles of standard induction and screening, enrolled patients receive high‑dose chemotherapy with autologous stem cell transplantation combined with BCMA‑targeted CAR‑T infusion, followed by GPRC5D/CD3 bispecific antibody maintenance. Maintenance duration is guided by depth of response and MRD: patients with sCR and sustained MRD negativity (≥12 months) receive 24 months of maintenance then observation, with reinitiation if MRD resurges, while others continue bispecific therapy until progression or unacceptable toxicity. The study is conducted at the Institute of Hematology & Blood Diseases Hospital in Tianjin, China, and requires on‑site procedures and follow‑up.

Why it matters

Who can join: the full rules

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.

Where it's running

• Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical Sciences
  Tianjin, Tianjin Municipality, China Recruiting

Study contacts

• Study coordinator: Gang An, PhD&MD
• Email: angang@ihcams.ac.cn
• Phone: 86-022-23909171

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.