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NCT05979363: CAREMM-002
A Study of Bortezomib, Lenalidomide and Dexamethasone (VRd)-Based Regimen Followed by BCMA CAR-T Therapy in Transplant-Ineligible Patients With Primary Plasma Cell Leukemia
Phase 2 trial testing anti-BCMA CAR-T in Plasma Cell Leukemia in 20 participants. Currently enrolling.
1 July 2026
Quick facts
| Lead sponsor | Institute of Hematology & Blood Diseases Hospital, China |
|---|---|
| Phase | Phase 2 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 20 |
| Start date | 14 August 2023 |
| Primary completion | 1 July 2026 |
| Estimated completion | 1 July 2028 |
| Sites | 1 location across China |
Drugs / interventions tested
- anti-BCMA CAR-T — full drug profile →
- VRD-based regimen — full drug profile →
Conditions studied
- Plasma Cell Leukemia — all drugs for Plasma Cell Leukemia →
Sponsor
Institute of Hematology & Blood Diseases Hospital, China
Who can join
Adults 18 to 75, any sex, with Plasma Cell Leukemia. 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-based regimen combined with BCMA CAR-T in transplant-ineligible patients with primary plasma cell leukemia
Publications & conference data
6 peer-reviewed publications reference this trial (live from Europe PMC):
-
Immunosenescence: signaling pathways, diseases and therapeutic targets.
Fu Y, Wang B, Alu A, Hong W, et al · · 2025 · cited 28× · PMID 40769978 · DOI 10.1038/s41392-025-02371-z -
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 -
Changing lanes: extending CAR T-cell therapy to high-risk plasma cell dyscrasias.
Morgan HT, Derman BA, Ma H, Kumar SK. · · 2025 · cited 4× · PMID 40264764 · DOI 10.3389/fimmu.2025.1558275 -
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 -
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 -
Primary Plasma Cell Leukemia: Recent Advances in Molecular Understanding and Treatment Approaches.
Hanamura I, Karnan S, Ota A, Takami A. · · 2025 · PMID 40649944 · DOI 10.3390/ijms26136166
Verify or expand the search:
- PubMed search for NCT05979363
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of anti-BCMA CAR-T
Trials testing the same drug.
- NCT05846737 — BCMA CAR-T Cell Therapy in High-risk NDMM Patients With Positive MRD After First-line ASCT · Phase 2 · recruiting
- NCT05860036 — A Study of VRd-based Regimen Followed by BCMA CAR-T Therapy in Transplant-Ineligible Patients With New-diagnosed Multipl · Phase 2 · active not recruiting
- NCT04637269 — Anti-BCMA CAR-T Cell Therapy for the R/R Multiple Myeloma · EARLY_PHASE1 · unknown
Other recruiting trials for Plasma Cell Leukemia
Currently open trials in the same condition.
- NCT06988059 — A Study of CT0596 in Plasma Cell Leukemia · EARLY_PHASE1 · recruiting
- NCT07109323 — Autologous Transplantation Combined With BCMA CAR-T in the Treatment of UHR-MM · Phase 1, PHASE2 · recruiting
- NCT06045091 — To Evaluate the Safety and Efficacy of Human BCMA Targeted CAR-NK Cells Injection for Subjects With R/R MM or PCL · EARLY_PHASE1 · recruiting
- NCT05805605 — Allo HSCT Using RIC and PTCy for Hematological Diseases · Phase 2 · recruiting
- NCT05822037 — CT0594CP CAR-T Cells in Patients With Relapsed/Refractory Multiple Myeloma or Plasma Cell Leukemia · NA · recruiting
Other Institute of Hematology & Blood Diseases Hospital, China trials
Trials by the same sponsor.
- NCT06991920 — Immune-targeted Combination With Chemotherapy for Acute Leukemia of Ambiguous Lineage · NA · not yet recruiting
- NCT07407010 — BCMA/CD3 Bispecific Antibody as Bridging Therapy Before CAR-T Cell Infusion in RRMM · Phase 1 · not yet recruiting
- NCT07407140 — VAG Versus Standard Chemotherapy With FLT3 Inhibitor in Adult Patients With FLT3-Mutated AML · Phase 3 · not yet recruiting
- NCT07454226 — ABL/JAK Inhibitors With Chemotherapy and Venetoclax for Ph-like ALL · NA · not yet recruiting
- NCT07490288 — Venetoclax, Azacitidine and Liposomal Mitoxantrone for Newly Diagnosed AML · NA · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05979363 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Institute of Hematology & Blood Diseases Hospital, China
- Last refreshed: 3 August 2025
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/NCT05979363.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing