MRD-Adaptive Guided Immunotherapy With CAR-T for Transplant-Ineligible Patients With Multiple Myeloma

Recruiting now · Phase 2

Conditions studied: Multiple Myeloma, Newly Diagnosed

In brief

This is a prospective, single-center, clinical study to evaluate the efficacy and safety of a fully immunotherapy-based strategy guided by MRD-driven dynamic risk stratification in transplant-ineligible patients with newly diagnosed multiple myeloma.

Key facts

Study ID

NCT07106736

Run by

Institute of Hematology & Blood Diseases Hospital, China

People needed

60

Starts

2025-08-10

Expected to finish

2029-08-01

Last updated by the study team

2025-08-06

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age ≥ 18 years and ≤ 75 years.
• Participants with documented newly-diagnosed multiple myeloma 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 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.
• 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.

You may not qualify if…

• Active amyloidosis.
• Central nervous system involvement.
• Prior BCMA-targeted therapy or CAR-T therapy.
• Active hepatitis B or hepatitis C virus infection.
• Known HIV infection.
• Life expectancy <6 months.
• Woman who are pregnant or breastfeeding.
• 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.

Where it is running

• Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical Sciences — Tianjin, Tianjin Municipality, China (enrolling)

Full record on ClinicalTrials.gov

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