Tecvayli (teclistamab-cqyv)

P4, N=200, Not yet recruiting, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences; Peking Union Medical College Hospital, Chinese Academy of Medical Sciences

P2, N=194, Active, not recruiting, Janssen Research & Development, LLC | Trial primary completion date: Nov 2025 --> Aug 2025

We furthermore discuss genetically engineered CD38 knock-out multitarget natural killer cells, expressing anti-B cell maturation antigen (BCMA) CAR, IL-15RF and hnCD16, administered in combination with daratumumab (anti-CD38) in this context...Likewise, we hypothesize the use of bi-specific T cell engagers such as CD19 blinatumomab or BCMA teclistamab for the treatment of AMR...In summary, anti-CD38 antibodies currently constitute the drug class with the strongest evidence for AMR treatment. To date, most CD38 antibodies have been shown to be safe, even after several years of administration in patients with multiple myeloma.

P2, N=100, Recruiting, SCRI Development Innovations, LLC | N=75 --> 100

We then summarize the clinical development and distinguishing features of currently approved BCMA-targeted modalities-CAR T-cell therapies (ide-cel, cilta-cel), bispecific T-cell engagers (teclistamab, elranatamab, linvoseltamab), and the antibody-drug conjugate (belantamab mafodotin)-highlighting their efficacy, toxicity profiles, and practical positioning in relapsed/refractory MM. Finally, we review emerging resistance mechanisms, including γ-secretase-driven sBCMA elevation, ligand-rich APRIL/BAFF niches, and therapy-induced TNFRSF17 lesions, ranging from biallelic deletions to epitope-altering missense mutations and in-frame deletions within the BCMA extracellular domain. These insights inform rational strategies such as γ-secretase inhibition, dual-target CAR T-cells and bispecific T-cell engagers.

P1, N=30, Not yet recruiting, National Cancer Institute (NCI)

P2, N=160, Recruiting, University of Heidelberg Medical Center | Trial completion date: Aug 2028 --> Sep 2029 | Trial primary completion date: Feb 2027 --> Sep 2028

P2, N=80, Not yet recruiting, National Cancer Institute (NCI) | Initiation date: Oct 2025 --> Jan 2026

IEC-HS is a rare but potentially fatal complication. Our disproportionality analysis identifies significant reporting signals for tisa-cel and cilta-cel. The high absolute number of cases observed for products like axi-cel appears to reflect high utilization rather than a disproportionate risk, underscoring the necessity of using statistical signal detection methods when interpreting spontaneous reports.

P4, N=15, Recruiting, University Health Network, Toronto | Not yet recruiting --> Recruiting | Trial completion date: Sep 2025 --> Oct 2026 | Trial primary completion date: Apr 2025 --> Jun 2026

P3, N=400, Not yet recruiting, Janssen Research & Development, LLC

P3, N=614, Active, not recruiting, Janssen Research & Development, LLC | Recruiting --> Active, not recruiting