MRD‑guided BCMA CAR-T with optional GPRC5D/CD3 BiTE consolidation for transplant‑ineligible 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

All participants receive up to four cycles of standard induction therapy, followed by response assessment and enrollment if they meet eligibility. Patients are stratified by predefined clinical and molecular features into standard‑risk and ultra‑high‑risk groups. Both groups receive BCMA‑directed CAR‑T; standard‑risk patients proceed to standard consolidation and maintenance while ultra‑high‑risk patients receive additional GPRC5D/CD3 bispecific antibody consolidation and maintenance. Those who achieve and sustain MRD negativity and stringent complete response may enter a treatment‑free observation phase, and any MRD resurgence prompts resumption of maintenance.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age ≥ 18 years and ≤ 75 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 ineligible for high-dose chemotherapy with ASCT due to any of the following: Age ≥65 years; Investigator assessment of ineligibility; ECOG performance status 3-4; Repeated failure of hematopoietic stem cell mobilization; Patient's decision to defer 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.

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.