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NCT07584889RecruitingPhase 1/2

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

Source: ClinicalTrials.gov · Last updated 13 May 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Phase 1/2
Study type
Interventional
Enrollment
10 (estimated)
First submitted
29 Apr 2026
Start date
20 Apr 2024
Primary completion date
19 Apr 2029
Lead sponsor
Shenzhen University General Hospital
NCT number
NCT07584889

What you commit to

  • Study type: Interventional · Phase 1/2
  • Planned participants: 10
  • From 20 Apr 2024 to the primary completion date, 19 Apr 2029
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Who the study is looking for

  • 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.

Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Shenzhen university General Hospital
Coordinator of this site? Confirm its status		ShenzhenChinaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.