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.
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: | Recruiting |
| Lead Sponsor: | EdiGene (GuangZhou) Inc. |
September 1, 2021