A Study of ET-02 in Patients With Relapsed or Refractory B-cell Malignancy(NHL/ALL)
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 |
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N/A |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: Four escalating dose-levels of ET-02 will be evaluated using a "3+3" design.
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Biological: ET-02
A conditioning therapy with cyclophosphamide and fludarabine will be conducted before ET-02 injection.
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Outcome Measures
Primary Outcome Measures
- Incidence of adverse events [up to 2 years after lymphodepleting chemotherapy]
Adverse events assessed according to NCI-CTCAE v5.0 criteria
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patients volunteer to participate in the study and sign the ICF;
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Male or female aged≥18 years old;
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Patient with relapsed or refractory CD19 positive B-ALL orNHL,as evidenced by 2 or more lines of prior therapy ;
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Estimated life expectancy≥12 weeks ;
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ECOG performance status ≤1;
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Adequate organ function.
Exclusion Criteria:
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Patients with graft-versus-host disease (GVHD) or requiring immunosuppressive therapy;
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History of central nervous system (CNS) involvement by malignancy;
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Women who are pregnant or breastfeeding;
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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 | |
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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.- EDI002