FDA approved subcutaneous isatuximab-irfc for multiple myeloma. Phase 3 EMN24 trial showed 77% MRD negativity with Isa-KRd quadruplet therapy. Phase 2 study showed 77% hematologic response rate in relapsed/refractory AL amyloidosis.
Updated data from the phase I CaMMouflage trial showed CB-011, the first allogeneic anti-BCMA CAR-T therapy with immune cloaking, achieved an approximately 92% overall response rate in relapsed/refractory multiple myeloma. The 2026 Tandem Meetings also highlighted advances in EB-103, KITE-753, and LV20.19 CAR-T constructs across lymphoma and CLL. Separately, NXC-201 reported a 95% complete response rate in AL amyloidosis.
The FDA has accepted an NDA for iberdomide in combination with anti-CD38 antibodies for relapsed or refractory multiple myeloma. A phase 2 study reports a 39% near complete response rate for the DaraKPd quadruplet therapy with durable MRD negativity. Preclinical research shows the RXR agonist IRX4204 sensitizes myeloma cells to ferroptosis and enhances lenalidomide efficacy.
BMS's mezigdomide doubled progression-free survival in relapsed/refractory multiple myeloma at ASCO, while the FDA reviews iberdomide with a decision due by August 17. C4 Therapeutics has dosed the first patient in its Phase 2 MOMENTUM trial of cemsidomide.
Cellectar Biosciences expanded its global IP estate and announced oversubscribed financing of up to $140 million. The funding supports iopofosine I 131 regulatory filings and a confirmatory study in Waldenström macroglobulinemia.
ALX Oncology has multiple 2026 catalysts for Evorpacept and ALX2004. Interim ASPEN-09 data are expected in Q3 2026, while an initial safety update from the phase 1 ALX2004 trial is expected in 1H 2026.
CAR T-cell therapy demonstrates near-98% response rates in multiple myeloma trials, but only 2.6% of eligible patients receive treatment. Black patients face substantially lower access, with structural and institutional barriers limiting availability of the specialized therapy.
MajesTEC-9 trial demonstrates teclistamab's superiority over standard care in second-line multiple myeloma treatment, with significant progression-free survival and overall survival benefits supporting earlier use of the BCMA-targeting bispecific antibody.
The FDA has granted fast track designation to QRX003 for Netherton Syndrome and IBI3003 for relapsed or refractory multiple myeloma, while also accepting regulatory applications for other therapies addressing serious conditions with unmet medical needs.
The FDA approved Tecvayli plus Darzalex Faspro for relapsed or refractory multiple myeloma after at least one prior therapy, and accepted a new drug application for iberdomide plus daratumumab and dexamethasone with a PDUFA date of August 17, 2026.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07369895 |
Clinical Study of O&D-001 Injection in the Treatment of Relapsed or Refractory Multiple Myeloma |
RECRUITING | PHASE1 |
| NCT07312188 |
A Study of F182112 in the Treatment of Patients With Relapsed or Refractory Multiple Myeloma |
RECRUITING | PHASE2 |
| NCT07138209 |
A Study Comparing QLS32015 Monotherapy Versus Pomalidomide, Dexamethasone (Pd) or Selinexor, Dexamethasone (Sd) in Participants With Relapsed or Refractory Multiple Myeloma |
RECRUITING | PHASE3 |
| NCT07116616 |
A Study of mRNA-2808 in Participants With Relapsed or Refractory Multiple Myeloma |
RECRUITING | PHASE1/PHASE2 |
| NCT07018050 |
Phase II Study of QLS32015 Combination Therapy in the Treatment of Multiple Myeloma |
RECRUITING | PHASE2 |
| NCT06825845 |
Long Term Follow-up Observational Study in Patients Treated with Gene-Modified T-Cell Therapy |
NOT_YET_RECRUITING | |
| NCT06604715 |
A Study of JNJ-87562761 in Participants With Relapsed or Refractory Multiple Myeloma |
RECRUITING | PHASE1 |
| NCT06574568 |
A Study of YKST02 in Participants With Relapsed or Refractory Multiple Myeloma |
RECRUITING | PHASE1 |
| NCT06500507 |
A Study of QLS4131 in Patients With Recurrent or Refractory Multiple Myeloma |
NOT_YET_RECRUITING | PHASE1 |
| NCT06425991 |
A Study Comparing Pre- and Post-Change Teclistamab in Participants With Relapsed or Refractory Multiple Myeloma |
ACTIVE_NOT_RECRUITING | PHASE1 |
