A Phase 1 Study to Evaluate the Safety of a Novel, In Vivo Gene Therapy to Create Anti-BCMA CAR-T Cells in Patients with Relapsed and Refractory Multiple Myeloma (NCT07075185)

KLN-1010 is a one-time treatment for Relapsed and Refractory Multiple Myeloma. KLN-1010 is a third generation, self-inactivating (SIN), replication incompetent, recombinant lentivirus (LVV) that contains modified envelope proteins to enable specific cell targeting and gene transfer of a fully human anti-B cell maturation antigen (BCMA) chimeric antigen receptor (CAR) in vivo.

Trial phase

Phase 1

Trial participation type

This trial has been designed for the Clinical Research of a Drug.

Principal investigator

Prof Andrew Spencer

Key inclusion data

Known central nervous system (CNS) involvement with myeloma; Ongoing toxicity from a prior therapy that has not resolved to ≤ Grade 1 or baseline, except alopecia and Grade 2 peripheral neuropathy; History of pulmonary embolism (PE) in the past 6 months or deep vein thrombosis (DVT) within 1 month of KLN-1010 infusion. Therapeutic dosing of anticoagulants (eg, warfarin, low molecular weight heparin (LMWH), Factor Xa inhibitors) is allowed for history of PE/DVT if greater than 1 month from the time of KLN-1010 infusion and should be on a stable dose.