CD19-CAR.p40-T cells for relapsed or treatment-resistant B cell blood cancers
Tests CD19-CAR.p40-T cells in adults whose CD19-positive blood cancers returned or resisted treatment.
Plain-language title generated from the registry record
Registry title: Efficacy and Safety of CD19-CAR.p40-T in Patients With Relapsed/Refractory CD19-Positive Hematologic Malignancies
Key facts
- Where
- Shenzhen, ChinaSee the site
- Phase
- Phase 1/2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Source: NCT07584889, who can take part
Where in China
- Shenzhen university General HospitalShenzhen, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Shenzhen University General Hospital
- Trial code
- NCT07584889
- Record updated
- 13 May 2026
- Original description
1. Study Title:Read full original descriptionShow less
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
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.
Inclusion: 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.