LCAR-F33S in Treatment of Relapsed/Refractory Multiple Myeloma
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorNanjing Legend Biotech Co.
About this trial
A prospective, single-arm, open-label dose-exploration and expansion study to evaluate the safety, tolerability, pharmacokinetics, and antitumor efficacy characteristics of LCAR-F33S in patients with relapsed/refractory multiple myeloma(Investigator-initiated Study).
Eligibility criteria
Qualifiers
Subjects voluntarily participate in clinical research.
Age ≥18 years old.
Eastern Cooperative Oncology Group (ECOG) score 0-2.
Examination evidence of initial diagnosis of MM according to IMWG diagnostic criteria.
Disqualifiers
Received previous therapy targeting FcRH5 targets.
Prior antineoplastic therapy and meet exclusion criteria (before apheresis);
Subjects had Plasma cell leukemia, Waldenstrom macroglobulinemia, POEMS syndrome, or primary AL amyloidosis at the time of screening.
Subjects who were positive for any of HBsAg, HBV DNA, HCV-Ab, HCV RNA, and HIV-Ab;
Trial design
Treatments tested in this trial
- LCAR- F33S cells intravenous infusion
Treatment groups
35 Participants
are divided into 1 treatment groupSponsors and collaborators
Nanjing Legend Biotech Co.
Lead sponsor
Institute of Hematology & Blood Diseases Hospital, China
Collaborator
Source ClinicalTrials.gov