A Study of ET-02 in Patients With Relapsed or Refractory B-cell Malignancy(NHL/ALL)
Not Applicable
Active, not recruiting
- Conditions
- Relapsed or Refractory B-cell Malignancy(NHL/ALL)
- Interventions
- Biological: ET-02
- Registration Number
- NCT04933825
- Lead Sponsor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 18
Inclusion Criteria
- Patients volunteer to participate in the study and sign the ICF;
- Male or female aged≥18 years old；
- Patient with relapsed or refractory CD19 positive B-ALL orNHL，as evidenced by 2 or more lines of prior therapy ;
- Estimated life expectancy≥12 weeks ;
- ECOG performance status ≤1;
- Adequate organ function.
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Exclusion Criteria
- Patients with graft-versus-host disease (GVHD) or requiring immunosuppressive therapy；
- History of central nervous system (CNS) involvement by malignancy；
- Women who are pregnant or breastfeeding；
- Any situations that may increase the risk of patients or interfere with the results of study，which judged by investigator.
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Four escalating dose-levels of ET-02 will be evaluated using a "3+3" design. ET-02 -
- Primary Outcome Measures
Name Time Method Incidence of adverse events up to 2 years after lymphodepleting chemotherapy Adverse events assessed according to NCI-CTCAE v5.0 criteria
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
•The First Affiliated Hospital of Henan University of Science and Technology
🇨🇳Luoyang, Henan, China