NCT05659628RecruitingPhase 1
CD19 CAR-T Expressing IL-7 and CCL19 Combined With Anti-PD1 in RR-DLBCL
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
Source: ClinicalTrials.gov · Last updated 21 Dec 2022 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 24 (estimated)
- First submitted
- 26 Nov 2022
- Start date
- Dec 2022
- Primary completion date
- Dec 2024
- Lead sponsor
- Ningbo No. 1 Hospital
- Diseases
- Diffuse large B-cell lymphoma
- NCT number
- NCT05659628
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 24
- From Dec 2022 to the primary completion date, Dec 2024
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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;
Other illness
- 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.
Other
- Known central nervous system lymphoma.
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The Second Affiliated Hospital of Zhejiang University, Ningbo First Hospital Coordinator of this site? Confirm its status | Hangzhou | China | Recruiting |
| Ningbo First Hospital Coordinator of this site? Confirm its status | Ningbo | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.