A Study of Automated Axicabtagene Ciloleucel for R/R Large B-cell Lymphoma.

NCT07606937 | Recruiting Early Phase 1 DMC

• 1 other identifier: FKC876-1
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 6

Brief Summary

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.

Conditions

Relapsed/Refractory Large B-cell Lymphoma

Outcome Measures

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)

  Up to 24 months

Secondary Outcomes (4)

• Complete response rate (CRR)

  Within 6 months,12 months, and 24 months after FKC876 infusion

• Duriation of response (DOR)

  Up to 24 months

• Progression-frees survival (PFS)

  Up to 24 months

• Overall survival(OS)

  Up to 24 months

Study Arms (1)

FKC876 injection

EXPERIMENTAL

Drug: FKC876 injection

Interventions

FKC876 injection DRUG

CD19 CAR-T

FKC876 injection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• The subject has at least one measurable lesion on imaging
• No clinical or historical evidence suggestive of lymphoma involvement of the central nervous system (CNS)
• A washout period of at least 2 weeks or 5 half-lives (whichever is shorter) from the last prior systemic therapy to the signing of the informed consent form.
• Toxicities due to prior therapy must be stable or recovered to ≤ Grade 1
• ECOG performance status of 0 or 1
• Adequate bone marrow, renal, hepatic, pulmonary and cardiac function
• Female subjects of childbearing potential must have a negative serum pregnancy test . Male and female subjects of childbearing potential must agree to use highly effective contraception during the study and for 6 months post-infusion.

You may not qualify if:

• 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
• Treatment with systemic immunostimulatory agents within 6 weeks or 5 half-lives of the drug, whichever is shorter, prior to the first dose of axicabtagene ciloleucel
• Prior chimeric antigen receptor therapy or other genetically modified T-cell therapy
• History of severe, immediate hypersensitivity reaction attributed to aminoglycosides or Tocilizumab
• Presence of fungal, bacterial, viral, or other infection that is uncontrolled or requiring intravenous (IV) antimicrobials for management
• Known history of infection with human immunodeficiency virus (HIV) or Positive test result for anti-Treponema pallidum antibody (TP-Ab) or hepatitis B(HBsAg positive) or hepatitis C virus (anti-HCV positive)
• Active tuberculosis
• Presence of any indwelling line or drain
• Subjects with detectable malignant cells in the cerebrospinal fluid (CSF) or known brain metastases or with a history of cerebrospinal fluid malignant cells or brain metastases
• History or presence of non-malignant CNS disorder
• Subjects with cardiac atrial or cardiac ventricular lymphoma involvement
• History of clinically significant cardiac disease within 12 months of enrollment

Sponsors & Collaborators

• Shenzhen Fosun Kairos Biotechnology Co., Ltd.: lead

Study Sites (6)

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100142, China

NOT YET RECRUITING

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510700, China

NOT YET RECRUITING

The Frist Affiliated Hospital of Soochow University

Suzhou, Jiangsu, 215006, China

NOT YET RECRUITING

Shanghai Jiaotong University School of Medicine Ruijin Hospital

Shanghai, Shanghai Municipality, 200025, China

RECRUITING

West China Hospotal Sichuan University

Chengdu, Sichuan, 610041, China

RECRUITING

Tianjin Medical University Cancer Institute & Hospital

Tianjin, Tianjin Municipality, 300000, China

RECRUITING

MeSH Terms

Conditions

Recurrence

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Wen Shi

  FosunKarios

  STUDY CHAIR

Central Study Contacts

Zhizhong Geng

CONTACT

8616601956551; eric.geng@fosunkairos.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2026
• First Posted: May 26, 2026
• Study Start: June 12, 2026
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: June 5, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (6)