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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
FKC876 injection
DrugCD19 CAR-T
Treatment groups
12 Participants
are divided into 1 treatment groupGroup A: FKC876 injectionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Objective response rate (ORR)
Proportion of subjects with a best overall response of complete remission (CR) or partial remission (PR), as assessed by the Lugano 2014 classification (Cheson 2014)
Time frame
Up to 24 monthsSecondary outcomes
1
Complete response rate (CRR)
Proportion of subjects achieving hematologic complete response (CR) according to the NCCN 2023
Time frame
Within 6 months,12 months, and 24 months after FKC876 infusion2
Duriation of response (DOR)
The time from the first objective response to disease progression (per Cheson 2014) or death due to any cause, whichever occurs first, in subjects who achieve an objective response.
Time frame
Up to 24 months3
Progression-frees survival (PFS)
The time from the date of axicabtagene ciloleucel infusion to disease progression or death due to any cause, whichever occurs first
Time frame
Up to 24 months4
Overall survival(OS)
The time from the date of axicabtagene ciloleucel infusion to death due to any cause.
Time frame
Up to 24 monthsSponsors and contacts
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Source ClinicalTrials.gov