PA3-17 Injection Treatment of Adult Patients With CD7-positive Relapsed/Refractory Lymphoid Hematologic Malignancies

Summary

This is a Phase I, open-label, dose-escalation clinical study with the primary objective of evaluating the safety and tolerability of PA3-17 injection in adult subjects with CD7-positive relapsed/refractory lymphoid hematologic malignancies. The secondary objectives are as follows: to evaluate the proliferation and in vivo persistence of CD7-targeted chimeric antigen receptor T (CAR-T) cells after injection of PA3-17; to evaluate the proportion of CD7-positive cells in peripheral blood after injection of PA3-17; to preliminarily evaluate the efficacy of PA3-17 injection in adult subjects with CD7-positive relapsed/refractory lymphoid hematologic malignancies; to evaluate the immunogenicity of PA3-17 injection; and to explore the applicable dose in Phase II trial.

Conditions

• CD7-positive Relapsed/Refractory Lymphoid Hematologic Malignancies

Interventions

BIOLOGICAL

T cell injection targeting CD7 chimeric antigen receptor

The subjects, who sign the informed consent forms and been screened by inclusion/exclusion criteria, will be assigned into 0.5 × 106, 2.0 × 106 and 4.0 × 106 CAR-T/kg groups in order of sequence. And the subjects will be administered once.

Sponsors & Collaborators

• The First Affiliated Hospital of Zhengzhou University

  collaborator OTHER

• Peking University People's Hospital

  collaborator OTHER

• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

  collaborator OTHER

• Hematology Hospital of Chinese Academy of Medical Sciences (Hematology Research Center of Chinese Academy of Medical Sciences)

  collaborator UNKNOWN

• Zhejiang University

  collaborator OTHER

• PersonGen BioTherapeutics (Suzhou) Co., Ltd.

  lead INDUSTRY

Principal Investigators

• Mingzhi Zhang, Doctor · The First Affiliated Hospital of Zhengzhou University

• Xiaojun Huang, Doctor · Peking University People's Hospital

• Heng Mei, Doctor · Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

• Dehui Zou, Doctor · Hematology Hospital of Chinese Academy of Medical Sciences (Hematology Research Center of Chinese Academy of Medical Sciences)

• He Huang, Doctor · Zhejiang University

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-12-01

Primary Completion

2022-12-01

Completion

2024-12-01

Countries

• China

Study Locations