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Relapsed/Refractory Large B-cell LymphomaEarly Phase 1NCT07606937

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

A Early Phase 1 study testing FKC876 injection in people with Relapsed/Refractory Large B-cell Lymphoma, run by Shenzhen Fosun Kairos Biotechnology Co., Ltd. at 6 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
FKC876 injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
6 sitesChina
Study dates
12 Jun 2026to 31 Dec 2026
Phase
Early Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)
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  • 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.

Who cannot join

  • 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
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  • 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
  • Requirement for urgent therapy within 6 weeks due to tumor mass effects, such as bowel obstruction or blood vessel compression or airway obstruction
  • 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.
  • History of symptomatic deep vein thrombosis or pulmonary embolism within 6 months of enrollment
  • Women of childbearing potential who are pregnant or breastfeeding
  • 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

Trial locations and contacts

6 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Zhizhong Geng contact

8616601956551

eric.geng@fosunkairos.com

6 sites in 1 country

China6 sites, 6 recruiting

  • Beijing Cancer Hospital

    Beijing, Beijing Municipality, 100142

    Beijing Cancer Hospital, +8601088196023

    Yuqin Song, Professor

    Not yet recruiting

  • West China Hospotal Sichuan University

    Chengdu, Sichuan, 610041

    West China Hospotal Sichuan University, +8618980601950

    Ting Niu, Professor

    Recruiting

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong, 510700

    Sun Yat-sen University Cancer Center, +8613926015016

    Huiqiang Huang, Professor

    Not yet recruiting

  • Shanghai Jiaotong University School of Medicine Ruijin Hospital

    Shanghai, Shanghai Municipality, 200025

    Shanghai Jiaotong University School of Medicine Ruijin Hospita, +8602164150275

    Weili Zhao, Professor

    Recruiting

  • The Frist Affiliated Hospital of Soochow University

    Suzhou, Jiangsu, 215006

    The Frist Affiliated Hospital of Soochow University, +86051267972858

    Yang Xu, Professor

    Not yet recruiting

  • Tianjin Medical University Cancer Institute & Hospital

    Tianjin, Tianjin Municipality, 300000

    Tianjin Medical University Cancer Institute & Hospital, +8613667005599

    Huilai Zhang, Professor

    Recruiting

Other trials in China

About this study

Official title: 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.

Read the 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.

Being tested
FKC876 injection
Medical subject headings
Recurrence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FKC876 injectionDrug

    CD19 CAR-T

Study groups in NCT07606937
Study groupRoleWhat they receive
FKC876 injectionExperimentalNot described
Receives: Drug: FKC876 injection

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

    Measured: Up to 24 months

Secondary outcomes (4)

  1. Complete response rate (CRR)

    Proportion of subjects achieving hematologic complete response (CR) according to the NCCN 2023

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

  2. 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.

    Measured: Up to 24 months

  3. 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

    Measured: Up to 24 months

  4. Overall survival(OS)

    The time from the date of axicabtagene ciloleucel infusion to death due to any cause.

    Measured: Up to 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 May 2026
  2. Study start12 Jun 2026 (estimated)
  3. Primary completion30 Nov 2026 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
12 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07606937
Sponsor's protocol ID
FKC876-1
Status last verified
Jun 2026
First submitted
19 May 2026
Last updated
5 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing FKC876 injection in people with Relapsed/Refractory Large B-cell Lymphoma, run by Shenzhen Fosun Kairos Biotechnology Co., Ltd. at 6 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 5 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Zhizhong Geng (8616601956551, eric.geng@fosunkairos.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective response rate (ORR) (time frame: Up to 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07606937.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2026.

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