CAR-T cell therapy with tislelizumab for relapsed or refractory large B-cell lymphoma
Tests CD19 CAR-T cells plus tislelizumab in adults with returned or non-responding large B-cell lymphoma.
Plain-language title generated from the registry record
Registry title: CD19 CAR-T Expressing IL-7 and CCL19 Combined With Anti-PD1 in RR-DLBCL
Key facts
- Where
- Hangzhou and Ningbo, ChinaSee the 2 sites
- Phase
- Phase 1
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Source: NCT05659628, who can take part
Where in China
- The Second Affiliated Hospital of Zhejiang University, Ningbo First HospitalHangzhou, ChinaTaking people
- Ningbo First HospitalNingbo, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Ningbo No. 1 Hospital
- Trial code
- NCT05659628
- Record updated
- 21 December 2022
- Original description
The goal of this clinical trial is to test CD19-7×19 CAR-T cells combined with Tislelizumab in refractory and relapsed diffuse large B lymphoma. The main question[s] it aims to answer are:Read full original descriptionShow less
Phase Ib Clinical Study of CD19 CAR-T Expressing IL-7 and CCL19 Combined With Tislelizumab in the Treatment of Relapsed/Refractory Diffuse Large B-cell Lymphoma
The goal of this clinical trial is to test CD19-7×19 CAR-T cells combined with Tislelizumab in refractory and relapsed diffuse large B lymphoma. The main question[s] it aims to answer are:
question 1：What is the safety of CD19-7×19 CAR-T cells combined with Tislelizumab in the treatment of relapsed or refractory diffuse large B-cell lymphoma.
question 2：What is the efficacy of CD19-7×19 CAR-T cells combined with Tislelizumab in the treatment of relapsed or refractory diffuse large B-cell lymphoma.
Participants will be asked to receive clinical evaluation before CAR-T, including physical examination, blood routine test, biochemical test, imaging test, etc.Peripheral blood lymphocytes will be collected for preparation of CAR-T cells after enrollment. Pretreatment chemotherapy with fludarabine and cyclophosphamide will be used before CAR-T infusion. On the 31st day after CAR-T infusion, Tislelizumab 200mg was given once every 21 days for 6 cycles. Participants will be required to report concomitant medication and adverse events, and their disease was evaluated throughout the study.
Inclusion: Age ≥ 18, upper limit 75, male or female; ECOG score 0-3; Histologically confirmed diffuse large B-cell lymphoma (DLBCL) [diagnostic criteria according to WHO 2008]; CD19 positive (immunohistochemistry or flow cytometry); DLBCL refractory or relapse is defined as: complete remission is not achieved after 2-line treatment; let What disease progress occurs during treatment, or the disease stability time is equal to or less than 6 months; Or autologous hematopoietic stem Disease progression or recurrence within 12 months after cell transplantation; Previous treatment for patients with diffuse large B cell lymphoma must include rituximab (CD20 monoclonal antibody) and anthracyclines; At least one measurable lesion is required, and any lymph node lesion with a length greater than 1.5cm or extranodal lesion is required If any length diameter is greater than 1.0 cm, the lesions on PET-CT scan have uptake (SUV is larger than liver blood pool); Absolute value of peripheral blood neutrophils ≥ 1000/ μ l. Platelets ≥ 45000/ μ l; Heart, liver and kidney functions: creatinine < 1.5mg/dL; ALT/AST Less than 2.5 times of normal upper limit; Total bilirubin < 1.5mg/dL; Cardiac ejection fraction (EF) ≥ 50%; Have sufficient understanding and voluntarily sign the informed consent form; People with fertility must be willing to use contraceptive methods; According to the judgment of the researcher, the expected survival period is at least 4 months; Willing to follow the visit schedule, administration plan, laboratory inspection and other test steps.
Exclusion: Autologous hematopoietic stem cell transplantation was performed within 6 weeks; Any target CAR-T treatment was performed within 3 months before this CAR-T treatment; Previously used any commercially available PD-1 monoclonal antibody; Cytotoxic drugs, glucocorticoids and other targeted drugs were received within 2 weeks before cell collection; Have a history of other tumors; Active autoimmune diseases; Uncontrollable active bacterial and fungal infections; HIV infection and syphilis infection; Active hepatitis B or hepatitis C: hepatitis B: HBV-DNA ≥ 1000 IU/mL; Hepatitis C: HCV RNA is positive and liver function is abnormal; Known central nervous system lymphoma.