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

February 15, 2023 updated by: EdiGene (GuangZhou) Inc.

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

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

18

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: up to 2 years after lymphodepleting chemotherapy
Adverse events assessed according to NCI-CTCAE v5.0 criteria
up to 2 years after lymphodepleting chemotherapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

EdiGene (GuangZhou) Inc.

Collaborators

The First Affiliated Hospital of Henan University of Science and Technology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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