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Single-arm, Open-label, Dose-escalating Phase I Clinical Study of PA3-17 Injection in Children and Adolescents With Relapsed/Refractory T-lymphoblastic Leukemia/Lymphoma

NCT07623681 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2026-06-03

No results posted yet for this study

Summary

This is a phase I, open-label, dose-escalation clinical trial. The primary objectives are to assess the safety of PA3-17 injection in pediatric and adolescent participants with relapsed/refractory T-lymphoblastic leukemia/lymphoma, and determine the recommended phase II dose of PA3-17 injection for this patient population.

Secondary objectives include evaluating the pharmacokinetics/pharmacodynamics, preliminarily assessing clinical efficacy, and evaluating the immunogenicity of the injection.

Conditions

  • CD7+ T-ALL/LBL

Interventions

BIOLOGICAL

T cell injection targeting CD7 chimeric antigen receptor

PA3-17 injection The subjects,who sign the informed consent forms and been screened by inclusion/exclusion criteria,will be assigned into 1.0\*10\^6,2.0\*10\^6 and 4.0\*10\^6 CAR-T/kg groups in order of sequence.And the subjects will be administered once.

Sponsors & Collaborators

  • PersonGen BioTherapeutics (Suzhou) Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Xiuli Ju, Doctor · Qilu Hospital of Shandong University

  • Xiaojun Xu, Doctor · The Children's Hospital of Zhejiang University School of Medicine

  • Fen Zhou, Doctor · Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
3 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-10
Primary Completion
2026-06-30
Completion
2028-07-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07623681 on ClinicalTrials.gov