Clinical trial · Interventional
U87 CART in Treatment of Advanced Solid Tumor
Clinical Study to Evaluate the Safety and Efficacy of U87 CART in Treatment of Advanced Solid Tumor
NCT05605197CI-TRIAL-00077479unknownPhase 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 is a single center, open-label, phase 1 study to evaluate the safety and efficacy of U87 CART in treating advanced solid tumor .
Conditions
Conditions (2)
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 |
| Solid Tumor, Adult | Adult Solid Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| U87 CAR-T | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- U87 CAR-T cells
- description
- The Patients are enrolled into 2 dose level cohorts in sequence
- interventionNames
- Drug: U87 CAR-T
Primary outcomes (1)
- measure
- Incidence of Adverse events after U87 CAR-T cells infusion [Safety and Tolerability]
- timeFrame
- 28 days post administration of CAR-T-cells
- description
- Therapy-related adverse events were recorded and assessed according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, Version 5.0) Dose-limiting toxicity after U87 CAR-T cells infusion.
Secondary outcomes (9)
- measure
- Disease control rate (DCR) of U87 CAR-T cells treatment in advanced solid tumor. [Effectiveness]
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Voluntary informed consent is given; 2. Age 18 to 75; 3. Patients with pathologically confirmed advanced solid tumor who have failed first-line therapy; or patients who are intolerant to first-line standard therapy and voluntarily give up standard therapy; 4. Immunohistochemical (IHC) staining of tumor tissue samples from patients was positive for U87 specific antigen (≥ 2 +, and the expression rate was ≥ 20%); 5. Expected survival ≥12 weeks; 6. Measurable tumor lesions according to RECIST 1.1; 7. ECOG performance score 0-1; 8. Sufficient venous access for mononuclear cell collection; 9. HBc Ab positive, HBsAg negative can be included in the group when the PCR detection of HBV DNA is negative; 10. Patients should maintain adequate organ function; 11. Dyspnea (CTCAE v5.0) ≤ Grade 1; Blood oxygen saturation\>91% without oxygen inhalation; 12. Pregnancy test was negative in women of childbearing age; Both male and female subjects should agree to use effective contraceptives during the treatment period and within the following year; Exclusion Criteria: 1. Pregnant or lactating women; 2. Uncontrolled active infections; 3. Active Syphilis, HIV, hepatitis B or hepatitis C infection; 4. Congenital immunodeficiency; 5. Have serious allergic reaction to any drug to be used in this study; 6. Other incurable malignant tumors in the past three years; 7. History or presence of clinically relevant CNS pathology such as epilepsy, Cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or any CNS-related autoimmune disease; 8. Have undergone cardiac angioplasty or stent implantation within 12 months, or have a history of myocardial infarction, unstable angina or other clinically significant heart diseases; 9. Subjects requiring anticoagulation or long-term antiplatelet therapy; 10. Subjects who have undergone major surgery or significant trauma within four weeks before enrolled in the study. 11. Other situations that the investigator thinks are not suitable for participating in this study.
References
Publications (0)
Data not yet available
No reference posted for this study.