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

• Conditions: Advanced Solid Tumor
• Interventions: Biological: liquid tumor infiltrating lymphocytes

• Registration Number: NCT04268108
• Lead Sponsor: Henan Cancer Hospital

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-02
• Study First Submitted: 2020-02-11
• Study First Submitted QC: 2020-02-11
• Study First Posted: 2020-02-13
• Study Start: 2020-04-02
• Last Update Submitted: 2020-06-10
• Last Update Posted: 2020-06-11
• Primary Completion: 2022-02-19
• Study Completion: 2022-06-19

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
group 1	liquid tumor infiltrating lymphocytes	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

Primary Outcome Measures

Name	Time	Method
the rate of reverse events	three months	the rate of reverse events

Secondary Outcome Measures

Name	Time	Method
clinical benefit rate	three months	the proportion of patients benefit from liquid tumor infiltrating lymphocytes
time to progression	six months	from the date of therapy to the first date of determined progressive disease

Trial Locations

Locations (1)

Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital; 🇨🇳 Zhengzhou, Henan, China