Clinical trial · Interventional
Clinical Study of ET019002-T Cell Therapy for Refractory/Relapsed B-Cell Malignancies
The Clinical Study of Structurally Optimized ET019002-T Cell Therapy for Refractory/Relapsed B-Cell Malignancies
NCT03642496CI-TRIAL-00034548unknownEarly Phase 1ClinicalTrials.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)
This study is to determine the safety, including potential dose limiting toxicities, and efficiency of ET019002-T cells and the duration of in vivo survival of ET019002-T cells in patients with relapsed/refractory B-Cell 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 |
|---|---|---|---|
| B-Cell Malignancies | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| High dose ET019002- T Cells | Biological | — | UNRESOLVED |
| Low dose ET019002- T Cells | Biological | — | UNRESOLVED |
| Middle dose ET019002- T Cells | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- The low dose group
- interventionNames
- Biological: Low dose ET019002- T Cells
- type
- EXPERIMENTAL
- label
- The middle dose group
- interventionNames
- Biological: Middle dose ET019002- T Cells
- type
- EXPERIMENTAL
- label
- The high dose group
- interventionNames
- Biological: High dose ET019002- T Cells
Primary outcomes (4)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 6 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Diagnosed B cell malignancies including: B-cell Acute Lymphoblastic Leukemia (B-ALL) and B cell lymphomas (DLBCL、FL、MZL、LPL、HCL、CLL、BL、MCL) * Refractory/Relapsed B cell malignancies: * Age 6-80 years, male or female * Nidus could be evaluated: minimum diameter of single nidus ≥10mm, and/or tumor cells in bone marrow ≥ 5% * ECOG≤2 points * Function of main organs or tissues were functional: Liver - ALT/AST≤3 normal upper limit, Serum total bilirubin (TBIL) ≤2 normal upper limit; Kidney - glomerular filtration rate (GFR) \> 60 mL/min/1.73 m2 or serum creatinine in normal range; Lunge - carbon monoxide diffusion capacity (DLCO) or forced expiratory volume in 1s (FEV) \>45% estimate; Heart - left ventricular ejection fraction (LVEF) ≥50% * Expecting life span ≥3 months * No chemotherapy, radiation therapy or immunotherapy in 2 weeks before enrollment * Fertile females/males consented to use contraceptives during participation of the trial * Patient or his/her custodia could understand and is willing to sign the written consent Exclusion Criteria: * Pregnancy or lactation * Couldn't use contraceptives during participation of the trial * Couldn't collect enough monocyte * Active and/or severe infection * HIV infection, active Hepatitis B or Hepatitis C infection * Had active autoimmune disease * Had non-melanoma skin carcinoma (NMSC) or Carcinoma in situ (e.g. cervix, bladder, galactophore) * Obvious clinical encephalopathy or novel neuron function damage * Organ failure: Heart - upper than NYHA level III or had uncontrolled malignant arrhythmia; Liver - upper than level III of Wuhan conference classification; Kidney - kidney failure stage3 or worse * Using immunosuppressive drugs or adreno-cortical hormone (ACH) within two weeks of enrollment * Insufficient T cell number or T cell transfection rate * Needed urgent disease controlling due to tumor load * Patients had biological treatment, immunotherapy or radiation therapy within 6 weeks prior to enrollment or are currently under these treatment * Substance abuse or drug addiction * lack of compliance, communication deficit or other unaccommodated situations
References
Publications (1)
- DERIVEDHe P, Liu H, Zimdahl B, Wang J, Luo M, Chang Q, Tian F, Ni F, Yu D, Liu H, Chen L, Wang H, Zhang M, Grupp SA, Liu C. A novel antibody-TCR (AbTCR) T-cell therapy is safe and effective against CD19-positive relapsed/refractory B-cell lymphoma. J Cancer Res Clin Oncol. 2023 Jul;149(7):2757-2769. doi: 10.1007/s00432-022-04132-9. Epub 2022 Jul 1. PMID 35776199