Actively Recruiting
CD19 CAR-T Expressing IL-7 and CCL19 Combined With Anti-PD1 in RR-DLBCL
Led by Ningbo No. 1 Hospital · Updated on 2022-12-21
24
Participants Needed
2
Research Sites
208 weeks
Total Duration
On this page
Sponsors
N
Ningbo No. 1 Hospital
Lead Sponsor
Z
Zhejiang University
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
CD19 CAR-T Expressing IL-7 and CCL19 Combined With Anti-PD1 in RR-DLBCL
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years, male or female
- ECOG performance score between 0 and 3
- Histologically confirmed diffuse large B-cell lymphoma (DLBCL) according to WHO 2008 criteria
- CD19 positive lymphoma confirmed by immunohistochemistry or flow cytometry
- Relapsed or refractory DLBCL defined by lack of complete remission after 2 lines of treatment, disease progression during treatment, or relapse within 12 months after autologous stem cell transplant
- Previous treatment must include rituximab (CD20 monoclonal antibody) and anthracyclines
- At least one measurable lesion with specific size and PET-CT uptake criteria
- Peripheral blood neutrophils ≥ 1000/μl and platelets ≥ 45000/μl
- Adequate heart, liver, and kidney function (creatinine < 1.5mg/dL, ALT/AST ≤ 2.5 times upper limit, total bilirubin < 1.5mg/dL, cardiac ejection fraction ≥ 50%)
- Ability to understand and sign informed consent
- Willingness to use contraception if of reproductive potential
- Expected survival of at least 4 months as judged by researcher
- Willingness to comply with visit schedules and test procedures
You will not qualify if you...
- History of other tumors
- Autologous hematopoietic stem cell transplantation within 6 weeks
- CAR-T cell therapy within 3 months prior to this treatment
- Previous use of any commercially available PD-1 monoclonal antibody
- Use of cytotoxic drugs, glucocorticoids, or targeted therapies within 2 weeks before cell collection
- Active autoimmune diseases
- Uncontrolled active bacterial or fungal infections
- HIV, syphilis infection, active hepatitis B (HBV-DNA ≥ 1000 IU/mL), or active hepatitis C with abnormal liver function
- Known central nervous system lymphoma
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
The Second Affiliated Hospital of Zhejiang University, Ningbo First Hospital
Hangzhou, Zhejiang, China, 310009
Actively Recruiting
2
Ningbo First Hospital
Ningbo, Zhejiang, China, 315010
Actively Recruiting
Research Team
L
Lixia Sheng, doctor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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