a Study of CT0596 in Relapsed/Refractory Multiple Myeloma and Relapsed/Refractory Plasma Cell Leukemia
Trial Parameters
Brief Summary
This study is a single-arm, open-label, exploratory dose-escalation and dose-finding clinical trial to evaluate the safety, efficacy, cellular pharmacokinetics and pharmacodynamics of CT0596 cells in patients with R/R MM and PCL.RRMM and RRpPCL
Eligibility Criteria
Inclusion Criteria: Participants must meet all of the following criteria to be enrolled: 1. Patients must voluntarily sign the informed consent form (ICF) and must be willing and be able to adhere to the trial visit schedule and other protocol requirements and agree to be in long term follow-up (LTFU) for up to 15 years as mandated by the regulatory guidelines. 2. Age ≥ 18 years; 3. Patients with R/RMM who have received at least 3 prior lines of therapy, including at least 1 proteasome inhibitor and at least 1 immunomodulator (IMiD). Patients with RRpPCL had received at least 1 prior line of therapy. Number of lines of therapy was defined according to the guidelines provided in Rajkuma\[1\]r 2015 . Patients must have received at least 1 complete cycle of therapy for each line of therapy. 4. According to multiple myeloma IMWG 2016 and plasma cell leukemia IMWG 2013, patients must have progressive disease following or during the last treatment. 5. Patients must have measurable disease ba