To Evaluate the Safety and Efficacy of Human CD19 Targeted DASH CAR-T Cells Injection for Subjects With R/R B-ALL

NCT05651191 · Status: UNKNOWN · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2022-12-14

No results posted yet for this study

Summary

This study is a single-arm, open-label, dose-escalation trial to explore the safety, tolerability and pharmacokinetic/pharmacodynamics characteristics of human CD19 targeted DASH CAR-T Cells injection, and to preliminarily observe the efficacy of the trial drug in patients with relapsed/refractory B-cell acute lymphoblastic leukemia.

Conditions

Interventions

DRUG

Human CD19 Targeted DASH CAR-T Cells Injection

Autologous genetically modified anti-CD19 CAR transduced T cells

Sponsors & Collaborators

  • Second Affiliated Hospital of Nanchang University

    collaborator OTHER
  • Hrain Biotechnology Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Qingming Wang, M.D. · Second Affiliated Hospital of Nanchang 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
2022-10-21
Primary Completion
2024-09-30
Completion
2025-09-30

Countries

  • China

Study Locations

More Related Trials

Entities

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 NCT05651191 on ClinicalTrials.gov