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

EdiGene

Status: Active, not recruiting

Conditions: Relapsed or Refractory B-cell Malignancy(NHL/ALL)

Treatments: Biological: ET-02

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04933825

EDI-002

Details and patient eligibility

About

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

Enrollment: 18 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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18 participants in 1 patient group

Four escalating dose-levels of ET-02 will be evaluated using a "3+3" design.

Experimental group

Treatment:

Biological: ET-02