Clinical trial · Interventional
A Study of ET-02 in Patients With Relapsed or Refractory B-cell Malignancy(NHL/ALL)
An Exploratory,Open-label,and Single Center Study to Evaluate the Safety and Efficacy of ET-02 in Patients With Relapsed or Refractory B-cell Malignancies(NHL/ALL).
NCT04933825CI-TRIAL-00064041unknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to evaluate the safety and efficacy of CD19-UCART in patients with r/r B-cell hematological malignancies.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Relapsed or Refractory B-cell Malignancy(NHL/ALL) | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ET-02 | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Four escalating dose-levels of ET-02 will be evaluated using a "3+3" design.
- interventionNames
- Biological: ET-02
Primary outcomes (1)
- measure
- Incidence of adverse events
- timeFrame
- up to 2 years after lymphodepleting chemotherapy
- description
- Adverse events assessed according to NCI-CTCAE v5.0 criteria
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.