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

Sponsor
EdiGene (GuangZhou) Inc. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04933825
Collaborator
The First Affiliated Hospital of Henan University of Science and Technology (Other)
18
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Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Biological: ET-02
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
18 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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).
Actual Study Start Date :
Jul 20, 2021
Anticipated Primary Completion Date :
Sep 30, 2024
Anticipated Study Completion Date :
Sep 30, 2024

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Incidence of adverse events [up to 2 years after lymphodepleting chemotherapy]

    Adverse events assessed according to NCI-CTCAE v5.0 criteria

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 •The First Affiliated Hospital of Henan University of Science and Technology Luoyang Henan China 471003

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
EdiGene (GuangZhou) Inc.
ClinicalTrials.gov Identifier:
NCT04933825
Other Study ID Numbers:
  • EDI002
First Posted:
Jun 22, 2021
Last Update Posted:
Sep 1, 2021
Last Verified:
Jun 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 1, 2021