Clinical trial · Interventional
Clinical Research of ROBO1 Specific BiCAR-NK Cells on Patients With Pancreatic Cancer
NCT03941457CI-TRIAL-00038521unknownPhase 1 / Phase 2ClinicalTrials.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)
Immunotherapy has become the major breakthrough and the most promising treatment, with the host of development of tumor biology, molecular biology and immunology. ROBO1 is a potential target and spectacular paradigm in the treatment of solid tumors. This study is for evaluation of the safety and efficacy of ROBO1 CAR-NK cell immunotherapy for pancreatic cancer.
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 |
|---|---|---|---|
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BiCAR-NK cells (ROBO1 CAR-NK cells) | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- anti-tumor response of BiCAR-NK cells (ROBO1 CAR-NK cells)
- description
- Patients with relapsed and refractory pancreatic cancer of ROBO1 expression will be treated with BiCAR-NK cells (ROBO1 CAR-NK cells).
- interventionNames
- Biological: BiCAR-NK cells (ROBO1 CAR-NK cells)
Primary outcomes (1)
- measure
- Occurrence of treatment related adverse events as assessed by CTCAE v4.03
- timeFrame
- 1 year
- description
- Defined as \>= Grade 3 signs/symptoms, laboratory toxicities, and clinical events) that are possibly, likely, or definitely related to study treatment.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Histologically confirmed metastatic pancreatic adenocarcinoma 2. Patients aged between 18 and 75 3. ROBO1 expression in malignancy tissues detected by immuno-histochemistry (IHC) 4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 5. Life expectancy greater than 3 months 6. Subjects must have measurable disease as defined by RECIST 1.1 criteria 7. Satisfactory organ and bone marrow function: White blood cell count (WBC) ≥ 3.0×10\^9/L, Platelets ≥ 70×10\^9/L, Hb ≥ 9.0g/dL, lymphocyte (LY) ≥ 0.7×10\^9/L, LY% ≥ 15%, Alb ≥ 2.8g/dL, serum lipase and amylase \< 1.5 × upper limit of normal, serum creatinine ≤ 2.5mg/dL, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 5×upper limit of normal, serum total bilirubin ≤ 2.0mg/dL. These tests must be conducted within 7 days prior to registration 8. Karnofsky score ≥ 60 9. Ability to give informed consent Exclusion Criteria: 1. Previously treated with any gene therapy products 2. Patients who are receiving any other investigational agents 3. Women of child-bearing potential who are pregnant or breastfeeding because of the potentially dangerous effects of the treatment on the fetus or infant 4. Active systemic infections (e.g.: requiring anti-infective treatment), coagulation disorders or any other major medical illnesses 5. Any form of primary immunodeficiency (such as Severe Combined Immunodeficiency Disease) 6. Concurrent opportunistic infections
References
Publications (0)
Data not yet available
No reference posted for this study.