ASCT Combined With BCMA CAR-T and GPRC5D/CD3 BiTEs Maintenance for Transplant-Eligible Ultra-High-Risk Multiple Myeloma

NCT07106710 | Recruiting Phase 2

• 1 other identifier: IIT2025049
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Multiple Myeloma, Newly Diagnosed

Keywords

Multiple myeloma; Ultra-high-risk; CAR-T; BiTEs; ASCT

Outcome Measures

Primary Outcomes (2)

• Sustained MRD-negative rate

  Rate of patients achieving sustained MRD negativity for more than 12 months

  Up to 2 year

• MRD negativity rate

  Rate of patients achieving MRD negativity

  Up to 2 years

Secondary Outcomes (4)

• Safety and Tolerability

  Up to 2 year

• Complete response rate (CRR)

  Up to 2 years

• Progression free survival (PFS)

  Up to 3 year

• Overall survival (OS)

  Up to 5 year

Study Arms (1)

ASCT Combined With BCMA CAR-T and GPRC5D/CD3 BiTEs Maintenance

EXPERIMENTAL

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 for ≥2 years.

Procedure: Autologous Hematopoietic Stem Cell Transplantation; Biological: BCMA CAR-T; Drug: GPRC5D/CD3 BiTEs

Interventions

Autologous Hematopoietic Stem Cell Transplantation PROCEDURE

Patients receive transplantation conditioning followed by autologous hematopoietic stem cell transplantation after successful stem cell mobilization and collection.

ASCT Combined With BCMA CAR-T and GPRC5D/CD3 BiTEs Maintenance

BCMA CAR-T BIOLOGICAL

Patients will receive BCMA CAR-T single dose (3.0 x 10\^6 cells /kg) infusion 3 days after ASCT.

ASCT Combined With BCMA CAR-T and GPRC5D/CD3 BiTEs Maintenance

GPRC5D/CD3 BiTEs DRUG

Patients will receive GPRC5D/CD3 BiTEs maintenance therapy at a dose of 54 μg/kg every 4 weeks, starting 3 months after BCMA CAR-T infusion and continuing for at least 2 years

ASCT Combined With BCMA CAR-T and GPRC5D/CD3 BiTEs Maintenance

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

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.

Sponsors & Collaborators

• Institute of Hematology & Blood Diseases Hospital, China: lead

Study Sites (1)

Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical Sciences

Tianjin, Tianjin Municipality, 300020, China

RECRUITING

MeSH Terms

Conditions

Multiple Myeloma; Bites and Stings

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases; Poisoning; Chemically-Induced Disorders; Wounds and Injuries

Central Study Contacts

Gang An, PhD&MD

CONTACT

86-022-23909171; angang@ihcams.ac.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2025
• First Posted: August 6, 2025
• Study Start: August 10, 2025
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2028
• Last Updated: August 6, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)