Relapsed or Refractory B-cell Malignancy(NHL/ALL)
Conditions
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.
Interventions
BIOLOGICALET-02
A conditioning therapy with cyclophosphamide and fludarabine will be conducted before ET-02 injection.
Sponsors
The First Affiliated Hospital of Henan University of Science and Technology
EdiGene (GuangZhou) Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of adverse events | up to 2 years after lymphodepleting chemotherapy | Adverse events assessed according to NCI-CTCAE v5.0 criteria |
Countries
China
Outcome results
None listed