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New treatment option for Diffuse Large B-cell Lymphoma
Official title CD19 CAR-T Expressing IL-7 and CCL19 Combined With Anti-PD1 in RR-DLBCL
ClinicalTrials.gov ID: NCT05659628
What this study is testing
What is CD19-7×19 CAR-T combined with Tislelizumab?
CD19-7×19 CAR-T combined with Tislelizumab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for diffuse large b-cell lymphoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 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...
You likely can't join if
- Have a history of other tumors;
- 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;
- Active autoimmune diseases;
See the full eligibility criteria
- 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...
- 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...
- 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.
- Have a history of other tumors;
- 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;
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Hangzhou, Zhejiang, China
- Ningbo, Zhejiang, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hangzhou, Zhejiang, China; Ningbo, Zhejiang, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.