Automated CAR-T Cell Therapy for Relapsed or Refractory Large B-Cell Lymphoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a single-arm, multicenter, open-label early-phase trial evaluating the safety and activity of an automated axicabtagene ciloleucel-like product (FKC876) in adults with relapsed or refractory large B-cell lymphoma after first-line therapy. Twelve participants will receive leukapheresis, bridging therapy, conditioning chemotherapy, and a single infusion of the study product. The study aims to determine whether the automated manufacturing process can produce effective CAR-T cells with manageable safety in this population. Patients must meet specific eligibility criteria including measurable disease, good performance status, and no CNS involvement. Primary endpoints typically focus on safety and preliminary efficacy, with ongoing monitoring for adverse events and responses.

Why it matters

Who can join: the full rules

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

Where it's running

• Shanghai Jiaotong University School of Medicine Ruijin Hospital
  Shanghai, Shanghai Municipality, China Recruiting
• West China Hospotal Sichuan University
  Chengdu, Sichuan, China Recruiting
• Tianjin Medical University Cancer Institute & Hospital
  Tianjin, Tianjin Municipality, China Recruiting
• Beijing Cancer Hospital
  Beijing, Beijing Municipality, China Not yet recruiting
• Sun Yat-sen University Cancer Center
  Guangzhou, Guangdong, China Not yet recruiting
• The Frist Affiliated Hospital of Soochow University
  Suzhou, Jiangsu, China Not yet recruiting

Study contacts

• Study coordinator: Zhizhong Geng
• Email: eric.geng@fosunkairos.com
• Phone: 8616601956551

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Linperlisib with immunochemotherapy for relapsed large B-cell lymphoma

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• Epcoritamab treatment for patients with large B-cell lymphoma after CAR T-cell therapy

  This study is testing if a new treatment called Epcoritamab, either on its own or with two other drugs, can help patients with large B-cell lymphoma who haven't responded well after CAR T-cell therapy.

  Recruiting at 3 sites Phase 2 Peter MacCallum Cancer Centre, Australia · Camperdown, New South Wales and 5 other locations · NCT06414148

• Evaluating Prizloncabtagene Autoleucel for patients with relapsed/refractory large B-cell lymphoma

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  Recruiting at 14 sites Phase 1/2 Shanghai AbelZeta Ltd. · Beijing and 14 other locations · NCT05800977

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.