Tests CAR-T and bispecific immunotherapy in newly diagnosed myeloma
Tests immune-based treatments in adults with newly diagnosed multiple myeloma who cannot have transplants.
Key facts
- Who runs it
- Institute of Hematology & Blood Diseases Hospital, China
- Where
- Tianjin, ChinaSee the site
- Trial code
- Registry title
- MRD-Adaptive Guided Immunotherapy With CAR-T for Transplant-Ineligible Patients With Multiple Myeloma
- Status
- Recruiting
- Phase
- Phase 2
- People taking part
- 60 people, planned
- Started
- 12 Aug 2025
- Expected to end
- 1 Aug 2029
- Type of study
- Interventional, 2 groups
- Treatments tested
- BCMA CAR-T
- GPRC5D/CD3 BiTEs
- Record updated
- 27 October 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults aged 18 to 75 with newly diagnosed multiple myeloma who cannot have a stem cell transplant with high-dose chemotherapy. Their tumor cells must be BCMA and GPRC5D positive.
- Age
- 18 to 75 years
- Sex
- All sexes can join.
- Disease stage
- Newly diagnosed multiple myeloma that can be measured by M-protein or free light chain blood or urine tests. People cannot have a stem cell transplant with high-dose chemotherapy because of age 65 or older, the investigator's assessment, ECOG performance status 3-4, repeated failure of stem cell collection, or their own decision to put the transplant off.
- Earlier treatment
- People cannot join if they had BCMA-targeted therapy or CAR-T therapy before.
- Biomarker or test result
- Tumor cells must be BCMA and GPRC5D positive.
Main reasons for not taking part
- Active amyloidosis
- Central nervous system involvement
- Prior BCMA-targeted therapy or CAR-T therapy
- Active hepatitis B or hepatitis C infection, or known HIV infection
- Pregnant or breastfeeding women
The registry criteria, word for word
Show all 16 criteriaShow less
Who can take part
- 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
Who cannot take part
- Prior BCMA-targeted therapy or CAR-T therapy
- Active hepatitis B or hepatitis C virus infection
- Known HIV infection
- 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
- Active amyloidosis
- Central nervous system involvement
- Life expectancy <6 months
- Woman who are pregnant or breastfeeding
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Where in China
- Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical SciencesTianjin, ChinaContact: Gang AnTaking people
About the trial
What the trial wants to find out
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.
The 2 groups in the trial
- Standard-riskTreatment being tested
Enrolled patients will be stratified into standard-risk group based on the absence of ultra-high-risk features, defined as: (1) double-hit cytogenetics, (2) presence of extramedullary disease, or (3) circulating tumor cells (CTCs) ≥2%. Patients in the standard-risk group will receive BCMA CAR-T therapy after standard induction, followed by standard consolidation and maintenance. Patients achieving sustained MRD negativity and stringent complete response (sCR) on two consecutive assessments may enter a treatment-free observation phase. Patients who experience MRD resurgence or loss of response will resume maintenance therapy.
Treatment: BCMA CAR-T
- Ultra high riskTreatment being tested
Enrolled patients will be stratified into an ultra-high-risk group based on the presence of ultra-high-risk features, defined as: (1) double-hit cytogenetics, (2) presence of extramedullary disease, or (3) circulating tumor cells (CTCs) ≥2%. Patients in the ultra-high-risk group will also receive BCMA CAR-T therapy after induction, followed by GPRC5D/CD3 bispecific antibody consolidation and maintenance. Patients achieving sCR and sustained MRD negativity (≥12 months) may enter treatment-free observation, while those with MRD resurgence or loss of response will resume maintenance therapy.
Treatment: BCMA CAR-T and GPRC5D/CD3 BiTEs
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- A Prospective, Open-Label, Single-Center Clinical Study of a Fully Immunotherapy-Based Strategy Driven by MRD-Guided Dynamic Risk Stratification in Transplant-Ineligible Newly Diagnosed Multiple Myeloma
- Plain-language title
- Tests CAR-T and bispecific immunotherapy in newly diagnosed myelomaGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Fit questions
- Built from NCT07106736, who can take part
- Record updated
- 27 October 2026