A Study of Automated Axicabtagene Ciloleucel for R/R Large B-cell Lymphoma.
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorShenzhen Fosun Kairos Biotechnology Co., Ltd.
About this trial
This study is a single-arm, multicenter, open-label clinical study evaluating the efficacy and safety of axicabtagene ciloleucel injection manufactured by an automated cell preparation process in adult subjects with relapsed or refractory large B-cell lymphoma (r/r LBCL) as second-line therapy.
Eligibility criteria
Qualifiers
Age 18 years or older at the time of informed consent
Has signed the informed consent form (ICF)
Histologically proven large B-cell lymphoma
Relapsed or refractory disease after first-line chemoimmunotherapy
Disqualifiers
Prior history of other malignancies, with the exception of non-melanoma skin tumors, carcinoma in situ , or follicular lymphoma that have been free of recurrence for more than 3 years.
History of Richter's transformation of CLL or PMBCL
History of autologous or allogeneic stem cell transplant
Received more than one line of therapy for DLBCL
Trial design
Treatments tested in this trial
- FKC876 injection
Treatment groups
12 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov