NCT07584889Toboroz1/2. fázis
Efficacy and Safety of CD19-CAR.p40-T in Patients With Relapsed/Refractory CD19-Positive Hematologic Malignancies
Efficacy and Safety of Autocrine p40-Expressing CD19-Targeted Chimeric Antigen Receptor T Cells (CD19-CAR.p40-T) in Patients With Relapsed/Refractory CD19-Positive Hematologic Malignancies
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. máj. 13.
Rövid összefoglaló (regiszter, angolul)
1. Study Title: A Study on the Efficacy and safety of Autocrine p40-Expressing CD19-Targeted Chimeric Antigen Receptor T Cells (CD19-CAR.p40-T) in Patients With Relapsed/Refractory CD19-Positive Hematologic Malignancies 2. Study Objectives: 2.1.1 Primary Objective To evaluate the safety of autocrine p40-expressing CD19-targeted chimeric antigen receptor T cells (CD19-CAR.p40-T) in the treatment of patients with relapsed/refractory CD19-positive hematologic malignancies. 2.1.2 Secondary Objective To evaluate the efficacy of autocrine p40-expressing CD19-targeted chimeric antigen receptor T cells (CD19-CAR.p40-T) in the treatment of patients with relapsed/refractory CD19-positive hematologic malignancies. 2.1.3 Exploratory Objective To evaluate the in vivo expansion and persistence of CD19-CAR.p40-T cells. 3. Participant Intervention: Participants will receive lymphodepleting chemotherapy (FC regimen: Fludarabine + Cyclophosphamide) on Days -5, -4, and -3 relative to the planned CD19-CAR.p40-T cell infusion. The CD19-CAR.p40-T cell infusion will be administered 72 hours after the completion of the FC chemotherapy.
- Állapot (regiszter)
- Toboroz
- Fázis (regiszter)
- 1/2. fázis
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 10 (tervezett)
- Első benyújtás
- 2026. ápr. 29.
- Kezdés
- 2024. ápr. 20.
- Elsődleges befejezés
- 2029. ápr. 19.
- Fő szponzor
- Shenzhen University General Hospital
- NCT-szám
- NCT07584889
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó · 1/2. fázis
- Tervezett résztvevők: 10
- 2024. ápr. 20. és az elsődleges befejezés (2029. ápr. 19.) között
- 1 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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Kiket keres a vizsgálat
- Subjects must meet all of the following criteria to be enrolled:
- • Aged 18 to 75 years, male or female;
- • Histologically or cytologically diagnosed with relapsed/refractory CD19-positive hematologic malignancy according to the 2022 World Health Organization (WHO) diagnostic criteria;
- • Eastern Cooperative Oncology Group (ECOG) performance status of 0-2;
- • Life expectancy of at least 3 months;
- • No contraindications to peripheral blood leukapheresis;
- • CD19 expression on tumor cells confirmed by flow cytometry and/or immunohistochemistry;
- • No severe cardiac, pulmonary, hepatic, or renal dysfunction;
- • Able to understand and willing to provide written informed consent. Exclusion Criteria
- Subjects who meet any of the following criteria should be excluded from enrollment:
- History of allergy to any component of the cellular product;
- Complete blood count meeting any of the following criteria: white blood cell count (WBC) ≤1 × 10⁹/L, absolute neutrophil count (ANC) ≤0.5 × 10⁹/L, absolute lymphocyte count (ALC) ≤0.5 × 10⁹/L, or platelet count (PLT) ≤25 × 10⁹/L;
- Laboratory abnormalities including, but not limited to, serum total bilirubin ≥1.5 mg/dL; serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >2.5 times the upper limit of normal; or serum creatinine ≥2.0 mg/dL;
- Class III or IV cardiac insufficiency according to the New York Heart Association (NYHA) functional classification, or left ventricular ejection fraction (LVEF) <50% by echocardiography;
- Abnormal pulmonary function, with oxygen saturation <92% on room air;
- History of myocardial infarction, cardiac angioplasty or stent placement, unstable angina, or other clinically significant severe cardiac disease within 12 months prior to enrollment;
- Grade 3 hypertension with poor blood pressure control despite medication;
- History of traumatic brain injury, disturbance of consciousness, epilepsy, severe cerebral ischemia, or cerebral hemorrhagic disease;
- Autoimmune disease, immunodeficiency, or other conditions requiring treatment with immunosuppressive agents;
- Uncontrolled active infection;
- Prior treatment with any CAR-T cell product or other genetically modified T-cell therapy;
- Receipt of a live vaccine within 4 weeks prior to enrollment;
- Positive test results for HIV, HBV, HCV, or TPPA/RPR, or HBV carrier status;
- History of alcohol abuse, drug abuse, or psychiatric illness;
- Participation in any other clinical study within 3 months prior to enrollment in this clinical study;
- Female subjects who meet any of the following conditions:
- Pregnant or breastfeeding;
- Planning to become pregnant during the study; or
- Of childbearing potential and unwilling or unable to use effective contraception;
- Any other condition that, in the investigator's opinion, makes the subject unsuitable for participation in this study.
Életkor a regiszterben: 18 év – 75 év · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Helyszínek (1)
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| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| Shenzhen university General Hospital | Shenzhen | Kína | Toboroz |
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