A Study of ET-02 in Patients With Relapsed or Refractory B-cell Malignancy(NHL/ALL)

An Exploratory,Open-label,and Single Center Study to Evaluate the Safety and Efficacy of ET-02 in Patients With Relapsed or Refractory B-cell Malignancies(NHL/ALL).

The purpose of this study is to evaluate the safety and efficacy of CD19-UCART in patients with r/r B-cell hematological malignancies.

Study Overview

• Status: Active, not recruiting
• Conditions: Relapsed or Refractory B-cell Malignancy(NHL/ALL)
• Intervention / Treatment: Biological: ET-02

• Study Type: Interventional
• Enrollment (Anticipated): 18
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Henan
    • Luoyang, Henan, China, 471003
      • •The First Affiliated Hospital of Henan University of Science and Technology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Patients volunteer to participate in the study and sign the ICF;
2. Male or female aged≥18 years old；
3. Patient with relapsed or refractory CD19 positive B-ALL orNHL，as evidenced by 2 or more lines of prior therapy ;
4. Estimated life expectancy≥12 weeks ;
5. ECOG performance status ≤1;
6. Adequate organ function.

Exclusion Criteria:

1. Patients with graft-versus-host disease (GVHD) or requiring immunosuppressive therapy；
2. History of central nervous system (CNS) involvement by malignancy；
3. Women who are pregnant or breastfeeding；
4. Any situations that may increase the risk of patients or interfere with the results of study，which judged by investigator.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Four escalating dose-levels of ET-02 will be evaluated using a "3+3" design.	Biological: ET-02; A conditioning therapy with cyclophosphamide and fludarabine will be conducted before ET-02 injection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of adverse events	Adverse events assessed according to NCI-CTCAE v5.0 criteria	up to 2 years after lymphodepleting chemotherapy

Collaborators and Investigators

• Sponsor: EdiGene (GuangZhou) Inc.
• Collaborators: The First Affiliated Hospital of Henan University of Science and Technology

Study record dates

Study Major Dates

• Study Start (Actual): July 20, 2021
• Primary Completion (Anticipated): September 30, 2024
• Study Completion (Anticipated): September 30, 2024

Study Registration Dates

• First Submitted: June 9, 2021
• First Submitted That Met QC Criteria: June 14, 2021
• First Posted (Actual): June 22, 2021

Study Record Updates

• Last Update Posted (Actual): February 17, 2023
• Last Update Submitted That Met QC Criteria: February 15, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: EDI-002

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No