P=N/A, N=20, Not yet recruiting, Institute of Hematology & Blood Diseases Hospital, China

Median number of prior lines was 4 (range 1-13), 19.4% had received CAR-T previously, and 12.9% had been previously exposed to another TCE.Twenty-three pts (74.2%) were enrolled in clinical trials (7 with teclistamab, Tec, 6 with talquetamab, Tal, and 10 with investigational agents). Twelve of these pts received TCE in combination with daratumumab and/or pomalidomide...MRD- seems to translate into long PFS, regardless of HR disease. Prospective studies on fixed duration treatment with TCE based on baseline risk and treatment response are needed.

P2, N=194, Active, not recruiting, Janssen Research & Development, LLC | Trial completion date: Sep 2025 --> Jun 2026

P1/2, N=228, Active, not recruiting, Janssen Research & Development, LLC | Recruiting --> Active, not recruiting

P=N/A, N=100, Recruiting, Universitaire Ziekenhuizen KU Leuven | Not yet recruiting --> Recruiting | Initiation date: Sep 2024 --> Dec 2024

P2, N=33, Not yet recruiting, University of California, San Diego

P2, N=75, Recruiting, SCRI Development Innovations, LLC | Trial completion date: Feb 2025 --> Aug 2025 | Trial primary completion date: Jan 2025 --> Jul 2025

P=N/A, N=150, Not yet recruiting, Pfizer | Trial completion date: Jan 2030 --> May 2030 | Initiation date: Oct 2024 --> Mar 2025 | Trial primary completion date: Jan 2030 --> May 2030

P1, N=20, Recruiting, University of Washington | Not yet recruiting --> Recruiting

Teclistamab (Tec), a bispecific antibody (BsAb) targeting BCMA, shows promise in refractory MM and, when combined with daratumumab (Tec-Dara), may help eliminate residual disease...Prior therapy exclusions apply, except for limited doses of dexamethasone, bortezomib, cyclophosphamide, lenalidomide, or daratumumab...The study seeks to determine if AHCT can be deferred in patients achieving MRD negativity after Dara-VRd without compromising the chance of reaching and sustaining MRD negativity, and whether post-AHCT Tec-Dara can enhance sustained MRD negativity rates compared to post-AHCT Dara-R in MRD-positive patients. The study is currently open for enrollment at multiple sites in the US.

P=N/A, N=20, Recruiting, Peking University People's Hospital

P1, N=48, Recruiting, GlaxoSmithKline | N=124 --> 48 | Trial completion date: Feb 2028 --> Sep 2028 | Trial primary completion date: Sep 2027 --> Sep 2028

P1/2, N=49, Recruiting, Brigham and Women's Hospital | Not yet recruiting --> Recruiting

P1, N=9, Terminated, Cartesian Therapeutics | Active, not recruiting --> Terminated; Phase 1 enrollment completed. Further clinical development terminated.

Currently, two BCMA-targeting BsAbs (teclistamab and elranatamab) and one GPRC5D-targeting BsAb (talquetamab) have regulatory approval for the treatment of patients (pts) with RRMM. Conclusions : CMMC counts through serial peripheral blood sampling can be used to assess disease burden and early kinetics of response to BsAb therapy. Further follow-up and additional cohorts are planned to confirm performance of this assay as a biomarker in predicting response and long-term outcomes in patients receiving BsAb and other therapies, as well as interrogating mechanisms of resistance through targeted sequencing and analysis of tumor-associated antigens of enumerated cells.

These retrospective clinical analyses show that teclistamab treatment can be restarted with minimal risk of CRS after prolonged treatment interruption when repeat SUD is implemented for interruptions of >62 days. These analyses were successfully informed using popPK modeling to recommend the appropriate intervals to repeat SUD when restarting teclistamab treatment, consistent with the European Medicines Agency–approved product label : if maintenance doses are delayed 8–62 days, continue teclistamab at the last maintenance dose and schedule; if delayed 63–111 days, restart teclistamab at SUD 2; if delayed >111 days, restart teclistamab at SUD 1.

B-cell maturation antigen (BCMA)-targeting bispecific T-cell engagers (BiTEs), Teclistimab and Elranatamab have shown rapid and durable responses in RRMM with a lower incidence and severity of cytokine release syndrome (CRS) compared to chimeric antigen receptor T-cell therapies...CRS occurred within 24 hours of the first priming dose, lasted two days, and resolved with IV fluids, tocilizumab, and dexamethasone without recurrence...Elranatamab was well-tolerated with no added toxicity and acceptable safety profile. These data support Elranatamab's use in relapsed/refractory AL amyloidosis and prospective studies using BCMA-targeting BiTEs in this high-risk, high-need population.

Conclusions : Tal-DP exhibits a deep, long-term impact on efficacy through complementary mechanisms of action and may be especially beneficial in pts with prior BsAb exposure, who typically have unfavorable BL immune profiles. Ongoing analyses of tec-DP from MajesTEC-2 (NCT04722146) will be presented.

P1/2, N=111, Recruiting, Sanofi | Trial primary completion date: Apr 2026 --> Mar 2027

P1/2, N=186, Not yet recruiting, Regeneron Pharmaceuticals

P2, N=300, Recruiting, Multiple Myeloma Research Consortium | Not yet recruiting --> Recruiting | Initiation date: Jul 2024 --> Nov 2024

P3, N=650, Recruiting, Janssen Research & Development, LLC | Trial primary completion date: Oct 2025 --> Feb 2026

P2, N=130, Recruiting, University of Heidelberg Medical Center | N=70 --> 130 | Trial completion date: Oct 2027 --> Aug 2028 | Trial primary completion date: Oct 2026 --> Feb 2027

P2, N=65, Not yet recruiting, Washington University School of Medicine | Trial completion date: Sep 2031 --> Dec 2031 | Initiation date: Sep 2024 --> Dec 2024 | Trial primary completion date: Sep 2031 --> Dec 2031

P1, N=156, Active, not recruiting, Celgene | Phase classification: P1/2 --> P1 | Trial primary completion date: Aug 2025 --> May 2025

P1, N=18, Not yet recruiting, Luminary Therapeutics | Initiation date: Jun 2024 --> Jan 2025 | Trial primary completion date: Oct 2025 --> Jan 2026

P1, N=174, Terminated, Amgen | Phase classification: P1/2 --> P1

P2, N=30, Not yet recruiting, European Myeloma Network B.V.

P2, N=40, Not yet recruiting, Ontario Clinical Oncology Group (OCOG) | Initiation date: Jul 2024 --> Nov 2024

P1, N=100, Active, not recruiting, Harpoon Therapeutics, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) | Trial primary completion date: Dec 2024 --> Jun 2025

P1/2, N=48, Recruiting, Keymed Biosciences Co.Ltd | Not yet recruiting --> Recruiting

"With the longest follow-up of any BsAb in MM, tec continues to demonstrate deep and durable responses, including in pts switching to less frequent dosing. The tec safety profile remains consistent with BCMA-targeted BsAb, with a notable decrease in new-onset severe infections with time."

P3, N=761, Recruiting, Pfizer | Active, not recruiting --> Recruiting

P1, N=74, Active, not recruiting, Janssen Research & Development, LLC | Trial primary completion date: Sep 2024 --> Feb 2025

P=N/A, N=0, Temporarily Not Available, Regeneron Pharmaceuticals

P=N/A, N=1, Active, not recruiting, Pfizer | N=700 --> 1

P=N/A, N=1, Active, not recruiting, Pfizer | Not yet recruiting --> Active, not recruiting | N=430 --> 1

P1, N=4, Completed, Pfizer | Active, not recruiting --> Completed

P1, N=180, Recruiting, Janssen Research & Development, LLC | Trial completion date: Apr 2026 --> Apr 2027

P1, N=302, Active, not recruiting, Janssen Research & Development, LLC | Recruiting --> Active, not recruiting

P1/2, N=38, Active, not recruiting, Pfizer | Phase classification: P2 --> P1/2

P1, N=180, Recruiting, TeneoOne Inc. | N=120 --> 180 | Trial completion date: Jul 2026 --> Mar 2027 | Trial primary completion date: Jul 2026 --> Mar 2027