A single-center phase I clinical trial is being conducted at the Department of Bone Marrow Transplantation and Cancer Immunotherapy, Hadassah Medical Center (HMO). The aim is to explore the safety and efficacy of the HBI0101 CAR T-cell product that we manufactured in-house. Enrolled R/R MM patients had previously undergone at least three lines of treatment including a PI, an IMiD, and an anti-CD38 antibody. Details of the complete study protocol, eligibility criteria, and study design are to be found in the Online Supplementary Table S1, Online Supplementary Figures S2 and S3. This study was authorized by the HMO institutional review board and by the Israeli Ministry of Health. The study was registered at clinicaltrials.gov (NCT04720313).
The phase I part of the trial was initiated in February 2021.
Enrolled patients underwent lymphopheresis, and collected cells were delivered to the Good Manufacturing Practice (GMP) facility for further stimulation, transduction, and expansion (Online Supplementary Figure S4). Bridging with local radiotherapy was allowed according to the physician's discretion. Patients' lymphodepletion before HBI0101 infusion was achieved by the administration of fludarabine 25 mg/m2 (link) and cyclophosphamide 250 mg/m2 (link) on days -5 to -3 (Online Supplementary Figure S2). Patients with creatinine clearance <30 mL/min received 90 mg/m2 (link) bendamustine on days -4 and -3. Fresh HBI0101 cells were administered at escalating doses of 150- (cohort 1), 450- (cohort 2), and 800x106 (cohort 3) CAR+ cells. In accordance with the study protocol, patients remained hospitalized for at least 10 days post infusion. During hospitalization, patients were followed daily for adverse events (AE), and according to a pre-defined schedule for safety and efficacy. (See Online Supplementary Figure S2 for details.)
The phase I part of the trial was initiated in February 2021.
Enrolled patients underwent lymphopheresis, and collected cells were delivered to the Good Manufacturing Practice (GMP) facility for further stimulation, transduction, and expansion (Online Supplementary Figure S4). Bridging with local radiotherapy was allowed according to the physician's discretion. Patients' lymphodepletion before HBI0101 infusion was achieved by the administration of fludarabine 25 mg/m2 (link) and cyclophosphamide 250 mg/m2 (link) on days -5 to -3 (Online Supplementary Figure S2). Patients with creatinine clearance <30 mL/min received 90 mg/m2 (link) bendamustine on days -4 and -3. Fresh HBI0101 cells were administered at escalating doses of 150- (cohort 1), 450- (cohort 2), and 800x106 (cohort 3) CAR+ cells. In accordance with the study protocol, patients remained hospitalized for at least 10 days post infusion. During hospitalization, patients were followed daily for adverse events (AE), and according to a pre-defined schedule for safety and efficacy. (See Online Supplementary Figure S2 for details.)
