Clinical Trials /

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

NCT04933825

Description:

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

Related Conditions:
  • B-Cell Acute Lymphoblastic Leukemia
  • B-Cell Non-Hodgkin Lymphoma
Recruiting Status:

Not yet recruiting

Phase:

N/A

Trial Eligibility

Document

Title

  • Brief Title: A Study of ET-02 in Patients With Relapsed or Refractory B-cell Malignancy(NHL/ALL)
  • Official Title: 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).

Clinical Trial IDs

  • ORG STUDY ID: EDI002
  • NCT ID: NCT04933825

Conditions

  • Relapsed or Refractory B-cell Malignancy(NHL/ALL)

Interventions

DrugSynonymsArms
ET-02Four escalating dose-levels of ET-02 will be evaluated using a "3+3" design.

Purpose

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

Trial Arms

NameTypeDescriptionInterventions
Four escalating dose-levels of ET-02 will be evaluated using a "3+3" design.Experimental
  • ET-02

Eligibility Criteria

        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.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

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

Details

Phase:N/A
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:EdiGene (GuangZhou) Inc.

Last Updated

June 22, 2021