NCT05659628Toboroz1. fázis
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
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2022. dec. 21. · Több mint 12 hónapja nem frissült - kérdezd meg a helyszínt, nyitott-e még
Rövid összefoglaló (regiszter, angolul)
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.
- Állapot (regiszter)
- Toboroz
- Fázis (regiszter)
- 1. fázis
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 24 (tervezett)
- Első benyújtás
- 2022. nov. 26.
- Kezdés
- 2022. dec.
- Elsődleges befejezés
- 2024. dec.
- Fő szponzor
- Ningbo No. 1 Hospital
- Betegségek
- Diffúz nagy B-sejtes limfóma (DLBCL)
- NCT-szám
- NCT05659628
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó · 1. fázis
- Tervezett résztvevők: 24
- 2022. dec. és az elsődleges befejezés (2024. dec.) között
- 2 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.
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Korábbi kezelés
- 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;
Más betegség
- 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.
Egyéb
- Known central nervous system lymphoma.
Kiket keres a vizsgálat
- 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.
Életkor a regiszterben: 18 év – 75 év · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Helyszínek (2)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| The Second Affiliated Hospital of Zhejiang University, Ningbo First Hospital | Hangzhou | Kína | Toboroz |
| Ningbo First Hospital | Ningbo | Kína | Toboroz |
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