RecruitingPhase 4NCT06609304

Axicabtagene Ciloleucel for Consolidation After First-line Treatment of High-risk Large B-cell Lymphoma

Prospective Clinical Study of Axicabtagene Ciloleucel for Consolidation After First-line Treatment of High-risk Large B-cell Lymphoma

Sponsor

Zhengzhou University

Enrollment

20 participants

Start Date

Sep 30, 2024

Study Type

INTERVENTIONAL

Conditions

Lymphoma, B-Cell

Summary

The goal of this clinical trial is to learn if Axicabtagene Ciloleucel (axi-cel) works for consolidation after first-line treatment of high-risk Large B-cell Lymphoma (LBCL). It will also learn about the safety of axi-cel treatment. The main questions it aims to answer are: * Does axi-cel treatment result in prolonged clinical benefit to patients with high-risk LBCL after first-line treatment? * What medical problems do participants have when receiving axi-cel treatment? In this investigator-initiated, single-arm clinical trial, participants will: * Receive atezolizumab treatment at 2.0×10\^6 cells/Kg as a one-time therapy. * Visit the clinic as instructed for checkups and tests.

Eligibility

Min Age: 18 YearsMax Age: 70 Years

Inclusion Criteria8

Understand and voluntarily sign the informed consent form;
years of age (inclusive);
Previously untreated CD19-positive large B-cell lymphoma;
Anticipated survival ≥12 weeks;
Adequate bone marrow reserve prior to apheresis
Appropriate organ function:
Eastern Cooperative Oncology Group (ECOG) Physical Status Score of 0 or 1; 8. Absence of CNS lymphoma;
\. Negative blood/urine pregnancy test in women of childbearing age.

Exclusion Criteria11

History of allergy to any of the components of the cell product;
History of stem cell transplantation;
History of organ transplantation;
Presence of active infections;
Current or history of central nervous system disorders;
Previous treatment with other modified T-cell therapy;
Previous treatment with anti-CD19/CD3 or other anti-CD19 therapies;
Malignancies other than those indicated for this trial;
History of any prior systemic immune checkpoint therapy;
History of short-acting cell growth factors or haematopoietic agonists/stimulants ;
History of a live vaccine within 3 months prior to screening;.