NCT07106710RecruitingPhase 2
ASCT Combined With BCMA CAR-T and GPRC5D/CD3 BiTEs Maintenance for Transplant-Eligible Ultra-High-Risk Multiple Myeloma
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
Source: ClinicalTrials.gov · Last updated 27 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 30 Jul 2025
- Start date
- 15 Aug 2025
- Primary completion date
- 1 Aug 2027
- Lead sponsor
- Institute of Hematology & Blood Diseases Hospital, China
- Diseases
- Multiple myeloma
- NCT number
- NCT07106710
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 30
- From 15 Aug 2025 to the primary completion date, 1 Aug 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior BCMA-targeted therapy or CAR-T therapy.
Other illness
- 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.
Other
- Active amyloidosis.
- Central nervous system involvement.
- Life expectancy \<6 months.
- Woman who are pregnant or breastfeeding.
Who the study is looking for
- 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.
Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical Sciences Coordinator of this site? Confirm its status | Tianjin | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.