NCT04303520

Anti-CD19/CD22 Bispecific CAR-T Cell Therapy for CD19-positive ALL

A Phase I Clinical Trial of T-Cells Targeting CD19 and CD22 for Subjects With CD19-positive Acute Lymphoblastic Leukemia

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: The Second Affiliated Hospital of Henan University of Traditional Chinese Medicine · Academic / Other
• Sex: All
• Age: 13 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to study the feasibility and efficacy of anti-CD19/CD22 bispecific chimeric antigen receptors (CARs) T cell therapy for CD19-positive Acute Lymphoblastic Leukemia.

Detailed description

Primary Objectives 1\. To determine the feasibility ad safety of anti-CD19/ CD22 CAR-T cells in treating patients with CD19-positive Acute Lymphoblastic Leukemia. Secondary Objectives 1. To determine in vivo expression, dynamics and persistency of anti-CD19/CD22 CAR-T cells. 2. To determine in vivo expression of CD19-positive B cells. 3. To access the complete remission rate (ORR) in patients with ALL with 3 months after CD19/CD22 CAR-T cells infusion. 4. To investigate the favorable CD19/CD22 CAR-T cells dose and dosage regimen for the Phase II Clinical Trial.

Conditions

• CD19-positive ALL

Interventions

Type	Name	Description
BIOLOGICAL	anti-CD19/CD22 CAR-T cells	Retroviral vector-transduced autologous T cells to express anti-CD19 and anti-CD22 CARs
DRUG	Fludarabine	30mg/m2/d
DRUG	Cyclophosphamide	500mg/m2/d

Timeline

• Start date: 2018-05-03
• Primary completion: 2020-09-01
• Completion: 2021-02-01
• First posted: 2020-03-11
• Last updated: 2020-03-11

Locations

1 site across 1 country: China