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

June 2, 2026 updated by: Shenzhen Fosun Kairos Biotechnology Co., Ltd.

A Single-arm, Multicenter Clinical Study Evaluating the Efficacy and Safety of Axicabtagene Ciloleucel Injection Manufactured by an Automated Process in Patients With Relapsed/Refractory Large B-cell Lymphoma.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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. A total of 12 adult subjects with r/r LBCL who are refractory to first-line immunochemotherapy or who relapse within 12 months after first-line immunochemotherapy will be enrolled. All subjects will undergo leukapheresis, bridging therapy, conditioning chemotherapy, and a single study drug infusion.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
12

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100142
        • Not yet recruiting
        • Beijing Cancer Hospital
        • Contact:
          • Beijing Cancer Hospital
          • Phone Number: +8601088196023
        • Principal Investigator:
          • Yuqin Song, Professor
    • Guangdong
      • Guangzhou, Guangdong, China, 510700
        • Not yet recruiting
        • Sun Yat-sen University Cancer Center
        • Contact:
          • Sun Yat-sen University Cancer Center
          • Phone Number: +8613926015016
        • Principal Investigator:
          • Huiqiang Huang, Professor
    • Jiangsu
      • Suzhou, Jiangsu, China, 215006
        • Not yet recruiting
        • The Frist Affiliated Hospital of Soochow University
        • Contact:
          • The Frist Affiliated Hospital of Soochow University
          • Phone Number: +86051267972858
        • Principal Investigator:
          • Yang Xu, Professor
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200025
        • Recruiting
        • Shanghai Jiaotong University School of Medicine Ruijin Hospital
        • Principal Investigator:
          • Weili Zhao, Professor
        • Contact:
          • Shanghai Jiaotong University School of Medicine Ruijin Hospita
          • Phone Number: +8602164150275
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • Recruiting
        • West China Hospotal Sichuan University
        • Contact:
          • West China Hospotal Sichuan University
          • Phone Number: +8618980601950
        • Principal Investigator:
          • Ting Niu, Professor
    • Tianjin Municipality
      • Tianjin, Tianjin Municipality, China, 300000
        • Recruiting
        • Tianjin Medical University Cancer Institute & Hospital
        • Contact:
          • Tianjin Medical University Cancer Institute & Hospital
          • Phone Number: +8613667005599
        • Principal Investigator:
          • Huilai Zhang, Professor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age 18 years or older at the time of informed consent
  2. Has signed the informed consent form (ICF)
  3. Histologically proven large B-cell lymphoma
  4. Relapsed or refractory disease after first-line chemoimmunotherapy
  5. The subject has at least one measurable lesion on imaging
  6. No clinical or historical evidence suggestive of lymphoma involvement of the central nervous system (CNS)
  7. 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.
  8. Toxicities due to prior therapy must be stable or recovered to ≤ Grade 1
  9. ECOG performance status of 0 or 1
  10. Adequate bone marrow, renal, hepatic, pulmonary and cardiac function
  11. 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.

Exclusion Criteria:

  1. 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.
  2. History of Richter's transformation of CLL or PMBCL
  3. History of autologous or allogeneic stem cell transplant
  4. Received more than one line of therapy for DLBCL
  5. 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
  6. Prior chimeric antigen receptor therapy or other genetically modified T-cell therapy
  7. History of severe, immediate hypersensitivity reaction attributed to aminoglycosides or Tocilizumab
  8. Presence of fungal, bacterial, viral, or other infection that is uncontrolled or requiring intravenous (IV) antimicrobials for management
  9. 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)
  10. Active tuberculosis
  11. Presence of any indwelling line or drain
  12. 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
  13. History or presence of non-malignant CNS disorder
  14. Subjects with cardiac atrial or cardiac ventricular lymphoma involvement
  15. History of clinically significant cardiac disease within 12 months of enrollment
  16. Requirement for urgent therapy within 6 weeks due to tumor mass effects, such as bowel obstruction or blood vessel compression or airway obstruction
  17. Patients with idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on chest CT are excluded.
  18. History of symptomatic deep vein thrombosis or pulmonary embolism within 6 months of enrollment
  19. Women of childbearing potential who are pregnant or breastfeeding
  20. In the investigator's judgment, the subject is unlikely to complete all protocol-required study visits or procedures, including follow-up visits, or comply with the study requirements for participation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: FKC876 injection
Drug: FKC876 injection
CD19 CAR-T

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Objective response rate (ORR)
Time Frame: Up to 24 months
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Complete response rate (CRR)
Time Frame: Within 6 months,12 months, and 24 months after FKC876 infusion
Proportion of subjects achieving hematologic complete response (CR) according to the NCCN 2023
Within 6 months,12 months, and 24 months after FKC876 infusion
Duriation of response (DOR)
Time Frame: Up to 24 months
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.
Up to 24 months
Progression-frees survival (PFS)
Time Frame: Up to 24 months
The time from the date of axicabtagene ciloleucel infusion to disease progression or death due to any cause, whichever occurs first
Up to 24 months
Overall survival(OS)
Time Frame: Up to 24 months
The time from the date of axicabtagene ciloleucel infusion to death due to any cause.
Up to 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Shenzhen Fosun Kairos Biotechnology Co., Ltd.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Wen Shi, FosunKarios

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 12, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 30, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 19, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 19, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 26, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 5, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 2, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • FKC876-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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