A Study of ET-02 in Patients With Relapsed or Refractory B-cell Malignancy(NHL/ALL)
NCT ID: NCT04933825
Last Updated: 2023-02-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
18 participants
INTERVENTIONAL
2021-07-20
2024-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Four escalating dose-levels of ET-02 will be evaluated using a "3+3" design.
ET-02
A conditioning therapy with cyclophosphamide and fludarabine will be conducted before ET-02 injection.
Interventions
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ET-02
A conditioning therapy with cyclophosphamide and fludarabine will be conducted before ET-02 injection.
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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The First Affiliated Hospital of Henan University of Science and Technology
OTHER
EdiGene (GuangZhou) Inc.
INDUSTRY
Responsible Party
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Locations
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•The First Affiliated Hospital of Henan University of Science and Technology
Luoyang, Henan, China
Countries
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Other Identifiers
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EDI-002
Identifier Type: -
Identifier Source: org_study_id
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