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A single-arm multicenter clinical study for Neoantigen-reactive T cells (NRT) in the treatment of advanced non-small cell lung cancer

A single-arm multicenter clinical study for Neoantigen-reactive T cells (NRT) in the treatment of advanced non-small cell lung cancer

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000037775
Enrollment
Unknown
Registered
2020-09-01
Start date
2020-10-01
Completion date
Unknown
Last updated
2020-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced Non-Small Cell Lung Cancer

Interventions

Sponsors

Dongfang Hospital Affiliated to Tongji University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Volunteer to join this study and sign an informed consent form; 2. Aged 18-75 years old; 3. Non-small cell lung cancer, subjects who have not benefited from conventional standard treatment; 4. According to imRECIST evaluation criteria, there is at least one measurable lesion; 5. Expected survival period >=3 months; 6. The Eastern Cooperative Oncology Group (ECOG) score is 0 or 1; 7. The following hematological indicators need to be met: neutrophil count >=1.5x10^9/L; hemoglobin >=10.0 g/dL; platelet count >=50x10^9/L; The following biochemical indicators need to be met: total bilirubin <=2.0 ULN; AST and ALT <=2.0 ULN; serum creatinine <=1.5 ULN.

Exclusion criteria

Exclusion criteria: 1. Subjects infected with HBV, HCV, HIV, syphilis and tuberculosis; 2. Uncontrollable coronary artery disease or asthma, uncontrollable cerebrovascular disease or other diseases considered by the researcher to be incompatible with the group; 3. Those with a history of bone marrow or organ transplantation; those with coagulation dysfunction; 4. Those who suffer from immunodeficiency diseases or autoimmune diseases who are treated with immunosuppressive drugs. 5. Central nervous system (CNS) metastasis and/or cancerous meningitis; 6. Those who may be allergic to immunotherapy; 7. Drug abuse, clinical or psychological or social factors affect informed consent or research implementation; 8. Pregnant and lactating women; 9. Are participating in other clinical trials; The investigator considers uncertain factors that affect the safety or compliance of subjects.

Design outcomes

Secondary

MeasureTime frame
ORR;OS;PFS;DOR;EORTC QLQ-C30 V3.0;Immunological indicators;

Primary

MeasureTime frame
Safety Index;

Countries

CHINA

Contacts

Public ContactQiang Li

Dongfang Hospital Affiliated to Tongji University; P&PMed(Shanghai)Biotechnology Co.,Led.

liqressh@hotmail.com+86 021 6156 9717

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026