L-TIL in Patients With Malignancy Resistance to Anti-PD-1 Therapy

Henan Cancer Hospital

Status: Unknown

Conditions: Advanced Solid Tumor

Treatments: Biological: liquid tumor infiltrating lymphocytes

Study type: Observational

Funder types: Other

Identifiers

NCT04268108

Liquid TIL

Details and patient eligibility

About

Safety and effectiveness of liquid tumor infiltrating lymphocytes in patients with advanced malignant tumors who have failed to anti-PD-1 therapy

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Expected lifespan is over 3 months
• malignant tumors diagnosed by pathological examination
• Imaging examination is at advanced stage with at least one measurable lesion
• Ineffective or resistant to previous anti-PD-1 therapy
• ECOG score 0-2
• Adequate organ function
• No other serious diseases that conflict with this protocol
• Women of childbearing age must check for a negative blood pregnancy test within 7 days, and subjects of childbearing age must use appropriate contraception during the test and within 3 months
• witten informed consent from the patients

Exclusion criteria

• Severe infectious disease within 4 weeks before enrollment
• Active hepatitis B or C virus or HIV infection
• Severe autoimmune disease or immunodeficiency disease
• Severe allergies
• Severe mental disorder
• Systematically used a large amount of glucocorticoids within 4 weeks before enrollment
• With severe heart, liver, kidney insufficiency, diabetes and other diseases
• Participation in other clinical studies in the past 3 months or having been treated with other gene products

Trial design

30 participants in 1 patient group

group 1

Description:

arm 1: secondary resistance to anti-PD-1 therapy: this patients group received liquid tumor infiltrating lymphocytes combined anti-PD-1 therapy. arm 2: primary resistance to anti-PD-1 therapy: this patients group received FC preconditioning before received liquid tumor infiltrating lymphocytes

Treatment:

Biological: liquid tumor infiltrating lymphocytes