Description:
The purpose of this study is to evaluate the safety and efficacy of CD19-UCART in patients with r/r B-cell hematological malignancies.
The purpose of this study is to evaluate the safety and efficacy of CD19-UCART in patients with r/r B-cell hematological malignancies.
Not yet recruiting
N/A
Drug | Synonyms | Arms |
---|---|---|
ET-02 | Four escalating dose-levels of ET-02 will be evaluated using a "3+3" design. |
Name | Type | Description | Interventions |
---|---|---|---|
Four escalating dose-levels of ET-02 will be evaluated using a "3+3" design. | Experimental |
|
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.
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Measure: | Incidence of adverse events |
Time Frame: | up to 2 years after lymphodepleting chemotherapy |
Safety Issue: | |
Description: | Adverse events assessed according to NCI-CTCAE v5.0 criteria |
Phase: | N/A |
Primary Purpose: | Interventional |
Overall Status: | Not yet recruiting |
Lead Sponsor: | EdiGene (GuangZhou) Inc. |
June 22, 2021