NCT07316907
Not yet recruiting
Phase 1
An Exploratory Clinical Study of the Safety and Efficacy of Allogenic CD19-Targeted Chimeric Antigen Receptor T-Cell Injection in the Treatment of Relapsed/Refractory B-Cell Hematologic Malignancies
YANRU WANG1 site in 1 country12 target enrollmentStarted: December 22, 2025Last updated:
Interventions19UCART injection
Overview
- Phase
- Phase 1
- Status
- Not yet recruiting
- Sponsor
- YANRU WANG
- Enrollment
- 12
- Locations
- 1
- Primary Endpoint
- Toxicity and adverse-event grading after 19UCART treatment
Overview
Brief Summary
This is a single-arm, open-label pilot study to evaluate the safety and efficacy of CD19-targeted allogenic CAR-T cells (19UCART) in patients with relapsed/refractory B-cell hematologic malignancies. 12 patients are planned to be enrolled in the dose-escalation trial. The primary objective of the study is to evaluation of the safety and feasibility of 19UCART for the treatment of relapsed/refractory B-cell hematologic malignancies. The secondary objective is to evaluate the efficacy of 19UCART for the treatment of relapsed/refractory B-cell hematologic malignancies. The exploratory objective is to evaluate expansion, persistence and ability of 19UCART to deplete CD19 positive cells in patients with relapsed/refractory B-cell hematologic malignancies.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Voluntary participation in this trial with signed informed consent.
- •Diagnosis of B-cell hematologic malignancy according to the 2017 WHO classification, including B-acute lymphoblastic leukemia (B-ALL) and mature B-cell lymphomas such as diffuse large B-cell lymphoma (DLBCL), follicular lymphoma (FL), marginal-zone lymphoma (MZL), small lymphocytic lymphoma/chronic lymphocytic leukemia (SLL/CLL), mantle-cell lymphoma (MCL), etc.
- •Refractory or relapsed B-cell malignancy defined as failure to achieve complete remission after standard therapy, or relapse after achieving remission with first-line or salvage therapy.
- •Persistence of minimal residual disease (MRD) positivity despite hematologic remission in B-cell acute lymphoblastic leukemia (ALL).
- •At least one measurable lesion ≥1.5 cm in longest diameter by IWG revised criteria for relapsed/refractory lymphoma.
- •Age 18-70 years; both sexes eligible.
- •Expected survival ≥12 weeks.
- •Adequate organ function as follows (no blood products or growth factors within 14 days before first infusion):
- •. Hematology: A. White blood cell count (WBC) ≥3.0×10⁹/L B. Absolute neutrophil count (ANC) ≥1.5×10⁹/L C. Platelet count (PLT) ≥100×10⁹/L D. Hemoglobin (Hb) ≥90 g/L 2). Renal: A. Serum creatinine ≤1.5×ULN or calculated creatinine clearance ≥60 mL/min 3). Cardiac: A. Left ventricular ejection fraction (LVEF) ≥50 % B. QTc (Fridericia) ≤450 ms (men) or ≤470 ms (women) 4). Hepatic: A. Total bilirubin ≤1.5×ULN B. Alanine aminotransferase (ALT) and Aspartate aminotransferase (AST) ≤2.5×ULN (≤5×ULN if liver involvement) 5). Coagulation: A. International normalized ratio (INR) or Prothrombin time (PT) ≤1.5×ULN B. Activated partial thromboplastin time (APTT) ≤1.5×ULN 6). Pulmonary: Diffusing capacity of the lung (DLCO) ≥50 % of predicted (with or without correction for anemia/alveolar volume).
- •9\. ECOG performance status 0-2 at screening.
Exclusion Criteria
- •Subjects with any of the following conditions are ineligible for this trial:
- •Known hypersensitivity, allergic reaction, intolerance, or contraindication to 19UCART or any study-drug component (including fludarabine, cyclophosphamide, or tocilizumab), or history of severe anaphylaxis.
- •Post-allo-HSCT relapse with active graft-versus-host disease requiring systemic corticosteroids or other immunosuppressants.
- •Uncontrolled active infection of any etiology.
- •Active hepatitis B, hepatitis C, or tuberculosis.
- •HIV or syphilis infection.
- •Active autoimmune disease or history of severe autoimmune disorder (as judged by the PI) requiring prolonged immunosuppressive therapy.
- •Congenital or acquired immunodeficiency syndromes.
- •New York Heart Association (NYHA) class III or IV heart failure, unstable angina, myocardial infarction within 6 months, or sustained (\>30 s) ventricular arrhythmia.
- •History of epilepsy or other significant central nervous system disorders.
Arms & Interventions
relapsed/refractory B-cell hematologic malignancies
Experimental
relapsed/refractory B-cell hematologic malignancies patients to be treated with 19UCART cells
Intervention: 19UCART injection (Biological)
Outcomes
Primary Outcomes
Toxicity and adverse-event grading after 19UCART treatment
Time Frame: up to 12 months after infusion
all toxicities and AEs will be assessed according to the National Cancer Institute CTCAE v5.0
CRS grading after 19UCART treatment
Time Frame: up to 12 months after infusion
CRS will be graded using the Lee DW et al. CRS grading scale
Secondary Outcomes
- Overall response rate (ORR = CR + PR) of patients receive 19UCART treatment(1, 3, 6, and 12 months after infusion)
- CAR copies and cell count of CAR-T in blood after 19UCART treatment(Day 0, 1, 3, 5, 7, 9, 11, 14, 21, 28, and month 2, 3, 6, 9, 12 after infusion)
- Disease control rate (DCR = CR + PR + SD) of patients receive 19UCART treatment(1, 3, 6, and 12 months after infusion)
- PET-CT Response Criteria according to Lugano metabolic response categories(1, 3, 6, and 12 months after infusion)
Investigators
YANRU WANG
Clinical Professor
Affiliated Hospital of Jiangsu University
Study Sites (1)
Loading locations...
Similar Trials
Not yet recruiting
Not Applicable
An Exploratory Clinical Study on the Safety and Efficacy of CD19/BCMA CAR-NK in the Treatment of Relapsed and Refractory IgG4-related DiseaseNCT07298590Changhai Hospital18
Recruiting
Not Applicable
Safety and Efficacy of CD19 Chimeric Antigen Receptor T-Cell (CAR-T) in the Treatment of Refractory Membranous NephropathyNCT07266181The First Affiliated Hospital of Air Force Medicial University5
Not yet recruiting
Not Applicable
CD19/BCMA CAR-T for SLENCT07266337Chengdu Ucello Biotechnology Co., Ltd.24
Not yet recruiting
Phase 1/2
CARLA-M19 : “Prospective non-randomized phase I/II study investigating the safety of CD19 CAR-T cells in patients with refractory/relapsed AML (Acute Myeloïd Leukemia) expressing CD19.”2023-509212-29-01Centre Hospitalier Universitaire De Lille5
Recruiting
Phase 1
A Study of AZD0120 in Autoimmune DiseasesNCT07295847AstraZeneca27