A Clinical Study of Allogenic CD19-CAR-T in the Treatment of R/R B-Cell Hematologic Malignancies

Sponsor
YANRU WANG
Study ID
NCT07316907
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • 19UCART injection — BIOLOGICAL
    19UCART injection is a CD19-targeted allogenic CAR-T. A single infusion of CAR-T cells will be administered intravenously.

Study Details

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.

Key Dates

First listed
Jan 5, 2026
Start date
Dec 22, 2025
Status verified
Dec 2025
Primary completion
Jun 30, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
12 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: relapsed/refractory B-cell hematologic malignancies
    relapsed/refractory B-cell hematologic malignancies patients to be treated with 19UCART cells

Primary Outcome Measure

Toxicity and adverse-event grading after 19UCART treatment [ Time Frame: up to 12 months after infusion ]

Central Contacts

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