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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04933825
Recruitment Status : Recruiting
First Posted : June 22, 2021
Last Update Posted : September 1, 2021
Sponsor:
Collaborator:
The First Affiliated Hospital of Henan University of Science and Technology
Information provided by (Responsible Party):
EdiGene (GuangZhou) Inc.

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
Relapsed or Refractory B-cell Malignancy(NHL/ALL) Biological: ET-02 Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : July 20, 2021
Estimated Primary Completion Date : September 30, 2024
Estimated Study Completion Date : September 30, 2024

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.




Primary Outcome Measures :
  1. Incidence of adverse events [ Time Frame: up to 2 years after lymphodepleting chemotherapy ]
    Adverse events assessed according to NCI-CTCAE v5.0 criteria



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04933825


Contacts
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Contact: Ling Qin, Ph.D +8613838837729 zzqq777@126.com

Locations
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China, Henan
•The First Affiliated Hospital of Henan University of Science and Technology Recruiting
Luoyang, Henan, China, 471003
Sponsors and Collaborators
EdiGene (GuangZhou) Inc.
The First Affiliated Hospital of Henan University of Science and Technology
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Responsible Party: EdiGene (GuangZhou) Inc.
ClinicalTrials.gov Identifier: NCT04933825    
Other Study ID Numbers: EDI002
First Posted: June 22, 2021    Key Record Dates
Last Update Posted: September 1, 2021
Last Verified: June 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neoplasms