Posted: Tuesday, September 5, 2023
According to Carlos Fernández de Larrea, MD, PhD, of the Hospital Clínic de Barcelona, and colleagues, in patients with relapsed or refractory multiple myeloma, the B-cell maturation antigen (BCMA)-targeted chimeric antigen receptor (CAR) T-cell therapy ARI0002h may provide deep and sustained responses when administered in a fractioned manner with a booster dose after 3 months. The results of an interim analysis from the multicenter CARTBCMA-HCB-01 trial, which were published in The Lancet Oncology, highlighted the treatment’s low neurologic toxicity and potential for point-of-care manufacturing.
“CAR T-cell therapy is a promising option for patients with heavily treated multiple myeloma,” the investigators remarked. “Point-of-care manufacturing can increase the availability of these treatments worldwide.”
A total of 30 patients who received at least two prior lines of therapy (including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody) were administered a fractionated infusion of 3 x 106/kg CAR-positive cells in three aliquots. After at least 100 days, they received a nonfractionated booster dose of up to 3 x 106/kg CAR-positive cells. Follow-up data were provided for a median of 12.1 months.
The investigators reported an overall response rate of 100% during the first 100 days after infusion, including a complete response rate of 50%, a very good partial response rate of 30% , and a partial response rate of 20%. Cytokine-release syndrome was observed in the majority of patients (80%; all grade 1 or 2). No cases of neurotoxic events were reported. A total of 67% of patients experienced persistent cytopenias of grade 3 or 4. Infections were reported in approximately two-thirds of the study population (67%). Three patients died during therapy: one from disease progression, one from a head injury, and one from COVID-19.
Disclosure: For full disclosures of the study authors, visit thelancet.com.