Efficacy and Safety of CD19-CAR.p40-T in Patients With Relapsed/Refractory CD19-Positive Hematologic Malignancies

NCT07584889 | Recruiting Phase 1

• 1 other identifier: 114
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

1. 1.Study Title:
2. 2.Study Objectives:
3. 3.Participant Intervention:

Conditions

B Cell Lymphoma; Acute Lymphoblastic Leukemia; Acute Myeloid Leukemia

Outcome Measures

Primary Outcomes (1)

• TEAEs

  Treatment-emergent adverse events will be evaluated and graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0

  From date of initial treatment to the 30 days after treatment

Secondary Outcomes (1)

• Disease-related clinical responses

  From date of enrollment until the date of clinical responses,up to 2 years

Study Arms (1)

CART group

EXPERIMENTAL

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.

Combination Product: CAR-T cell

Interventions

CAR-T cell COMBINATION_PRODUCT

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.

CART group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• Shenzhen University General Hospital: lead

Study Sites (1)

Shenzhen University General Hospital

Shenzhen, Other (Non U.s.), 518055, China

RECRUITING

MeSH Terms

Conditions

Lymphoma, B-Cell; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Myeloid, Acute

Interventions

Immunotherapy, Adoptive

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Leukemia, Lymphoid; Leukemia; Hematologic Diseases; Leukemia, Myeloid

Intervention Hierarchy (Ancestors)

Adoptive Transfer; Immunization, Passive; Immunization; Immunotherapy; Immunomodulation; Biological Therapy; Therapeutics; Immunologic Techniques; Investigative Techniques

Study Officials

• lixin wang, PHD

  Shenzhen University General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

lixin wang, PHD

CONTACT

0755-21839999; wanglixin1991@sohu.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single Group Assignment

Study Record Dates

• First Submitted: April 29, 2026
• First Posted: May 13, 2026
• Study Start: April 20, 2024
• Primary Completion (Estimated): April 19, 2029
• Study Completion (Estimated): April 19, 2029
• Last Updated: May 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)