Lymphoma, B-Cell
Conditions
Brief 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.
Interventions
BIOLOGICALAxicabtagene Ciloleucel
Axicabtagene Ciloleucel at 2.0×10\^6/Kg
Sponsors
Zhengzhou University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Understand and voluntarily sign the informed consent form; 2. 18-70 years of age (inclusive); 3. Previously untreated CD19-positive large B-cell lymphoma; 4. Anticipated survival ≥12 weeks; 5. Adequate bone marrow reserve prior to apheresis 6. Appropriate organ function: 7. Eastern Cooperative Oncology Group (ECOG) Physical Status Score of 0 or 1; 8. Absence of CNS lymphoma; 9\. Negative blood/urine pregnancy test in women of childbearing age.
Exclusion criteria
1. History of allergy to any of the components of the cell product; 2. History of stem cell transplantation; 3. History of organ transplantation; 4. Presence of active infections; 5. Current or history of central nervous system disorders; 6. Previous treatment with other modified T-cell therapy; 7. Previous treatment with anti-CD19/CD3 or other anti-CD19 therapies; 8. Malignancies other than those indicated for this trial; 9. History of any prior systemic immune checkpoint therapy; 10. History of short-acting cell growth factors or haematopoietic agonists/stimulants ; 11. History of a live vaccine within 3 months prior to screening;.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| one year PFS | From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months |
Countries
China
Contacts
Primary ContactZhang, PhD
Outcome results
None listed