Posted: Tuesday, July 12, 2022
According to Carlos Fernandez De Larrea, MD, PhD, of the University of Barcelona, and colleagues, the lentiviral autologous chimeric antigen receptor (CAR) T-cell product ARI0002h seems to be safe and active in patients with relapsed or refractory multiple myeloma. The results of the multicenter CARTBCMA-HCB-01 trial, which were presented during the European Hematology Association (EHA) 2022 Congress (Abstract S103), highlighted the absence of neurotoxicity and the feasibility of a second booster dose.
A total of 35 patients were enrolled and allowed bridging therapy between apheresis and lymphodepletion with cyclophosphamide plus fludarabine. Of this population, 30 were administered 3 x 106/kg CAR-positive cells in a fractionated manner. Patients who achieved any response and had not experienced serious complications were eligible to receive a second dose after at least 4 months.
The overall response rate was 100%, with a stringent complete remission plus a very good partial response rate of 90%. The median time to first response was 1 month. Of the 26 patients who were evaluable for measurable residual disease (MRD) after 100 days, 92% achieved MRD negativity in the bone marrow. A total of 53% of patients were alive and without disease progression at 16 months. The median duration of overall survival was not reached, and the 16-month overall survival rate was 80%.
Cytokine-release syndrome (87%), neutropenia (97%), anemia (85%), and thrombocytopenia (79%) were the most frequently reported adverse events. No cases of CAR T-cell–related neurotoxicity were reported. A total of 76% and 12% of patients were administered tocilizumab and corticosteroids, respectively. ARI0002h cells exhibited peak expansion on day 14.
Most eligible patients (86%) received a second dose. The median duration of time after the first infusion was 4 months, and 38% of patients received a second lymphodepletion regimen. After the second infusions, no relevant toxicities were reported. A total of 29% of patients had an improved response after reinfusion.
Disclosure: For full disclosures of the study authors, visit library.ehaweb.org.