Clinical trial · Interventional
Clinical Research of ROBO1 Specific BiCAR-NK/T Cells on Patients With Malignant Tumor
NCT03931720CI-TRIAL-00038370unknownPhase 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 diagnosis and treatment of solid tumors. This study is for evaluation of the safety and efficacy of ROBO1 CAR-NK/T cell immunotherapy for malignant tumors.
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 |
|---|---|---|---|
| Malignant Tumor | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BiCAR-NK/T cells (ROBO1 CAR-NK/T cells) | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- anti-tumor response of BiCAR-NK/T cells (ROBO1 CAR-NK/T cells)
- description
- Patients with relapsed and refractory cancer of ROBO1 expression will be treated with BiCAR-NK/T cells (ROBO1 CAR-NK/T cells).
- interventionNames
- Biological: BiCAR-NK/T cells (ROBO1 CAR-NK/T 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. Age 18\~75 years old, male or female 2. Life expectancy ≥ 6 months 3. ECOG score: 0-3 4. ROBO1 expression in malignancy tissues detected by immuno-histochemistry (IHC) 5. Advanced solid tumor was diagnosed by pathological or clinical physicians 6. Laboratory examination: white blood cell≥3 x 10\*9/L, blood platelet count≥70 x 10\*9/L, hemoglobin≥80g/L, lymphocyte count≥15%, total bilirubin≤100 mol/L, ALT and AST less than five times of the normal level, serum creatinine less than 1.5 times of the normal level 7. Signed informed consent 8. Women of child-bearing age must have evidence of negative pregnancy test and be willing to practice birth control after 2 weeks following the cell transfusion Exclusion Criteria: 1. Expected overall survival \< 6 months 2. Patients with uncontrolled hypertension, unstable coronary disease (uncontrolled arrhythmias, unstable angina, decompensated congestive heart failure (\> Class II, NYHA), or myocardial infarction within 6 months 3. Abnormal lung function: FEV (forced expiratory volume) \< 30% prediction, DLCO (diffusing capacity of the lung for carbon monoxide) \< 30% prediction, blood oxygen saturation \< 90% 4. Other serious diseases: nervous, mental disorders, immune regulatory diseases, metabolic diseases, infectious diseases, etc. 5. Unable or unwilling to provide informed consent, or fail to comply with the test requirements
References
Publications (0)
Data not yet available
No reference posted for this study.