Actively Recruiting
Efficacy and Safety of CD19-CAR.p40-T in Patients With Relapsed/Refractory CD19-Positive Hematologic Malignancies
Led by Shenzhen University General Hospital · Updated on 2026-05-13
10
Participants Needed
1
Research Sites
260 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Efficacy and Safety of CD19-CAR.p40-T in Patients With Relapsed/Refractory CD19-Positive Hematologic Malignancies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 to 75 years, male or female
- Diagnosed with relapsed or refractory CD19-positive hematologic malignancy per 2022 WHO criteria
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- Life expectancy of at least 3 months
- No contraindications to peripheral blood leukapheresis
- CD19 expression on tumor cells confirmed by flow cytometry or immunohistochemistry
- No severe cardiac, pulmonary, hepatic, or renal dysfunction
- Able to understand and willing to provide written informed consent
You will not qualify if you...
- Allergy to any component of the cellular product
- Abnormal blood counts: WBC ≤1 x 10⁹/L, ANC ≤0.5 x 10⁹/L, ALC ≤0.5 x 10⁹/L, or platelet count ≤25 x 10⁹/L
- Laboratory abnormalities including serum total bilirubin ≥1.5 mg/dL, ALT or AST >2.5 times upper limit of normal, or serum creatinine ≥2.0 mg/dL
- Class III or IV heart failure or left ventricular ejection fraction <50%
- Low oxygen saturation (<92%) on room air due to lung problems
- Recent severe cardiac events within 12 months prior to enrollment
- Grade 3 hypertension poorly controlled by medication
- History of severe brain injury or neurological disorders
- Autoimmune disease, immunodeficiency, or treatment with immunosuppressive agents
- Uncontrolled active infection
- Prior treatment with any CAR-T or genetically modified T-cell therapy
- Receipt of live vaccine within 4 weeks prior to enrollment
- Positive tests for HIV, HBV, HCV, or syphilis, or HBV carrier status
- History of alcohol or drug abuse, or psychiatric illness
- Participation in any other clinical study within 3 months prior to enrollment
- Female participants who are pregnant, breastfeeding, planning pregnancy, or unwilling/unable to use effective contraception
- Any other condition making the participant unsuitable as judged by the investigator
AI-Screening
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Trial Site Locations
Total: 1 location
1
Shenzhen University General Hospital
Shenzhen, Other (Non U.s.), China, 518055
Actively Recruiting
Research Team
L
lixin wang, PHD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
HEALTH_SERVICES_RESEARCH
Number of Arms
1
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