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Taking people in ChinaPhase 2

Tests stem cell transplant with CAR-T and maintenance treatment in multiple myeloma

Tests transplant, CAR-T cell therapy and follow-up drugs in adults with high-risk myeloma.

Key facts

Who runs it
Institute of Hematology & Blood Diseases Hospital, China
Where
Tianjin, ChinaSee the site
Trial code
Registry title
ASCT Combined With BCMA CAR-T and GPRC5D/CD3 BiTEs Maintenance for Transplant-Eligible Ultra-High-Risk Multiple Myeloma
Status
Recruiting
Phase
Phase 2
People taking part
30 people, planned
Started
15 Aug 2025
Expected to end
1 Aug 2028
Type of study
Interventional
Treatments tested
  • Autologous Hematopoietic Stem Cell Transplantation
  • 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 70 with newly diagnosed multiple myeloma at ultra-high risk, who can have a stem cell transplant using their own cells.

Age
18 to 70 years
Sex
All sexes can join.
Disease stage
Newly diagnosed multiple myeloma with measurable disease and at least one ultra-high-risk feature: two or more high-risk gene changes, soft tissue tumors outside the bone marrow, or 2% or more circulating plasma cells in the blood.
Earlier treatment
No earlier BCMA-targeted therapy or CAR-T therapy.
Biomarker or test result
The tumor cells must be positive for BCMA and GPRC5D.

Main reasons for not taking part

  • Active amyloidosis
  • Cancer in the central nervous system
  • Active hepatitis B or hepatitis C infection
  • Known HIV infection
  • Pregnant or breastfeeding women

The registry criteria, word for word

Show all 17 criteriaShow less

Who can take part

  • Age ≥ 18 years and ≤ 70 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 eligible for high-dose chemotherapy with ASCT
  • 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
  • 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 70 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-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.

The group in the trial

  • ASCT Combined With BCMA CAR-T and GPRC5D/CD3 BiTEs MaintenanceTreatment being tested

    Patients will undergo ASCT followed by BCMA CAR-T infusion. Three month after CAR-T cell infusion, patients will begin GPRC5D/CD3 BiTEs maintenance therapy.

    Treatment: Autologous Hematopoietic Stem Cell Transplantation, BCMA CAR-T, and GPRC5D/CD3 BiTEs

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
A Prospective, Single-Arm, Phase II Study 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
Plain-language title
Tests stem cell transplant with CAR-T and maintenance treatment in multiple 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 NCT07106710, who can take part
Record updated
27 October 2026