Study design and oversight
This is an investigator-initiated, open-label, single-arm, phase 1 study, which is conducted at Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, China. The study was registered at ClinicalTrials.gov, NCT04561557, and the protocol was approved by the Institutional Review Board of Tongji Hospital. All patients provided written informed consents before screening.A detailed treatment plan is provided in the study protocol (To allow CAR T-cell expansion, all patients were given lymphodepletion therapy, consisted of cyclophosphamide 500 mg/mThe sample size was based on a traditional 3 + 3 dose-escalation design and clinical considerations based on our previous study on CT103A in MM.