Actively Recruiting
Efficacy and Safety of Autocrine p40-Expressing CD19-Targeted CAR-T Cells 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
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the safety and effectiveness of autocrine p40-expressing CD19-targeted chimeric antigen receptor T cells (CD19-CAR.p40-T) in patients with relapsed or refractory CD19-positive blood cancers such as B cell lymphoma, acute lymphoblastic leukemia, and acute myeloid leukemia. These cancers have shown resistance or relapse after prior treatments, and this investigational therapy is designed to improve T-cell persistence and antitumor activity by genetically modifying the patient's own T cells. Participants will first receive lymphodepleting chemotherapy with fludarabine and cyclophosphamide on three consecutive days before the CAR-T cell infusion. Then, 72 hours after chemotherapy, a single intravenous infusion of the CD19-CAR.p40-T cells will be given. This study is a Phase I/II, single-arm trial that includes initial screening, leukapheresis to collect T cells, cell manufacturing, treatment, and follow-up. Throughout the study, participants will be closely monitored for safety concerns including cytokine release syndrome, neurotoxicity, infections, and blood-related toxicities. Disease response will be assessed using disease-specific criteria, and blood samples will be collected to track the expansion and persistence of the infused CAR-T cells. The primary safety evaluation will cover 30 days after treatment, with secondary assessments of clinical responses up to 2 years. The total study duration allows detailed observation of treatment effects and adverse events.
CONDITIONS
Brief 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/refractory CD19-positive hematologic malignancy based on 2022 WHO criteria
- ECOG performance status of 0 to 2
- Life expectancy of at least 3 months
- No contraindications to peripheral blood leukapheresis
- Confirmed CD19 expression on tumor cells 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
- White blood cell count less than or equal to 1 x 10^9/L, neutrophil count less than or equal to 0.5 x 10^9/L, lymphocyte count less than or equal to 0.5 x 10^9/L, or platelet count less than or equal to 25 x 10^9/L
- Liver or kidney lab abnormalities beyond defined limits
- Severe heart failure (NYHA class III or IV) or left ventricular ejection fraction below 50%
- Low oxygen saturation below 92% on room air
- Recent severe cardiac events within the past 12 months
- Poorly controlled severe hypertension
- History of serious brain injury, epilepsy, or cerebral hemorrhagic disease
- Autoimmune disease, immunodeficiency, or need for immunosuppressive treatment
- Active uncontrolled infection
- Prior CAR-T or other genetically modified T-cell therapy
- Recent live vaccine within 4 weeks
- Positive tests for HIV, HBV, HCV, or syphilis, or HBV carrier status
- History of alcohol or drug abuse, or psychiatric illness
- Participation in another clinical trial within 3 months
- Female participants who are pregnant, breastfeeding, planning pregnancy, or unwilling/unable to use contraception
- Any other condition making participation unsuitable as judged by the investigator
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Time required for cell manufacturing (variable)
Participants undergo leukapheresis to collect cells for manufacturing the autologous CD19-CAR.p40-T cell therapy.
1 visit for leukapheresis
Duration - 3 days
Participants receive lymphodepleting chemotherapy with fludarabine and cyclophosphamide over 3 days to prepare for CAR-T cell infusion.
3 visits (in-person) on Days -5, -4, and -3
Duration - Single day
Participants receive a single intravenous infusion of CD19-CAR.p40-T cells.
1 infusion visit (in-person)
Duration - Up to 2 years
Participants are closely monitored for safety, including adverse events, and undergo disease assessments according to response criteria. Blood samples are collected to evaluate pharmacokinetics and cellular kinetics of the CAR-T cells.
Frequent visits during first month post-infusion, then periodic visits up to 2 years
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
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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