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
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults aged 18 to 75 whose CD19-positive blood cancer has come back or has not responded to treatment. They get CAR-T cells made with an added p40 protein.
- Age
- 18 to 75 years
- Sex
- Men and women can join.
- Disease stage
- Relapsed or refractory (returned or not responding) CD19-positive blood cancer, confirmed by the 2022 WHO diagnostic criteria. CD19 on the tumour cells must be confirmed by a lab test. Daily-life ability (ECOG) of 0-2. Life expectancy of at least 3 months.
- Earlier treatment
- People who have had any CAR-T cell product or other genetically modified T-cell therapy cannot join. A live vaccine within 4 weeks before enrolment and joining another clinical study within 3 months before enrolment are also not allowed.
- Biomarker or test result
- CD19 on the tumour cells, confirmed by flow cytometry and/or immunohistochemistry.
Main reasons for not taking part
- Severe heart, lung, liver or kidney problems
- Autoimmune disease, immune deficiency or need for immune-suppressing drugs
- Uncontrolled active infection
- Positive test for HIV, HBV, HCV or syphilis
- Pregnant or breastfeeding, or planning pregnancy
Read by machine on 9 November 2026.
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?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial 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.