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NCT05860036

A Study of VRd-based Regimen Followed by BCMA CAR-T Therapy in Transplant-Ineligible Patients With New-diagnosed Multiple Myeloma

Active, enrolled Phase 2 Last updated 3 August 2025
What this trial tests

Phase 2 trial testing anti-BCMA CAR-T in Multiple Myeloma in 40 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline
4 April 2023
Primary endpoint
1 June 2025
10 March 2028

Quick facts

Lead sponsorInstitute of Hematology & Blood Diseases Hospital, China
PhasePhase 2
StatusActive, enrolled
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment40
Start date4 April 2023
Primary completion1 June 2025
Estimated completion10 March 2028
Sites1 location across China

Drugs / interventions tested

Conditions studied

Sponsor

Institute of Hematology & Blood Diseases Hospital, China

Who can join

Adults 18 to 75, any sex, with Multiple Myeloma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a single-arm, open-label study to evaluate the efficacy and safety of VRd(Bortezomib, Lenalidomide and Dexamethasone)-based regimen combined with BCMA CAR-T in Chinese transplant-ineligible patients with newly diagnosed multiple myeloma

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. CAR-T-Cell Therapy in Multiple Myeloma: B-Cell Maturation Antigen (BCMA) and Beyond.
    Mishra AK, Gupta A, Dagar G, Das D, et al · · 2023 · cited 29× · PMID 38006053 · DOI 10.3390/vaccines11111721
  2. Multiple myeloma: clinical characteristics, current therapies and emerging innovative treatments targeting ribosome biogenesis dynamics.
    Elbahoty MH, Papineni B, Samant RS. · · 2024 · cited 10× · PMID 39162964 · DOI 10.1007/s10585-024-10305-2
  3. Mechanisms of Resistance to CAR T-Cells and How to Overcome Them.
    Legato L, Bisio M, Fasano F, Benevolo Savelli C, et al · · 2025 · cited 3× · PMID 40981226 · DOI 10.3390/mps8050108
  4. Chimeric Antigen Receptor T Cells in the Treatment of Multiple Myeloma.
    Hasanali ZS, Razzo B, Susanibar-Adaniya SP, Garfall AL, et al · · 2024 · cited 3× · PMID 38158242 · DOI 10.1016/j.hoc.2023.12.004
  5. Feasibility of post-induction consolidation with BCMA CAR-T cell therapy in newly diagnosed multiple myeloma not proceeding to ASCT: A preliminary case series.
    Wu J, Zheng R, Ming X, Zhu X, et al · · 2026 · PMID 42179323 · DOI 10.1177/09636897261449972
  6. Combining Small-Molecular Compounds With CAR T-Cell Therapy: Novel Strategies for Enhanced Cancer Immunotherapy.
    Yi R, Zhang Z, Yang Y, Zhu H. · · 2026 · PMID 41978748 · DOI 10.1002/cai2.70053
  7. CAR-T therapy moving to first-line in multiple myeloma: latest updates from the 2025 ASH annual meeting.
    Geng C, Chen W, Zhu HH. · · 2026 · PMID 41975476 · DOI 10.1186/s13045-026-01793-8
  8. Phase II Study of BCMA Chimeric Antigen Receptor T-Cell Therapy in Patients With Newly Diagnosed Multiple Myeloma Ineligible for or Not Proceeding to Autologous Stem-Cell Transplantation (CAREMM-001).
    Yan W, Du C, Lv R, Zou H, et al · · 2026 · PMID 41759038 · DOI 10.1200/jco-25-01969

Verify or expand the search:

Other trials of anti-BCMA CAR-T

Trials testing the same drug.

Other recruiting trials for Multiple Myeloma

Currently open trials in the same condition.

Other Institute of Hematology & Blood Diseases Hospital, China trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05860036.

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