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

Advanced Solid Tumor Clinical Trial

Official title:

Clinical Study of Liquid Tumor Infiltrating Lymphocytes in Patients With Advanced Malignancies Resistance to Anti-PD-1 Therapy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04268108
• Other study ID #: Liquid TIL
• Status: Recruiting
• Start date: April 2, 2020
• Est. completion date: June 19, 2022

Study information

• Verified date: February 2020
• Source: Henan Cancer Hospital
• Contact: Quanli Gao, Dr.
• Phone: +86-371-65587795
• Email: gaoquanli2015[@]126.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: June 19, 2022
• Est. primary completion date: February 19, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Advanced Solid Tumor
• Neoplasms

Intervention

Biological:
• liquid tumor infiltrating lymphocytes
Isolatation and amplification PD-1+ cells from peripheral blood lymphocytes under GMP conditions for clinical use.

Locations

Country	Name	City	State
China	Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Henan Cancer Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the rate of reverse events	the rate of reverse events	three months
Secondary	clinical benefit rate	the proportion of patients benefit from liquid tumor infiltrating lymphocytes	three months
Secondary	time to progression	from the date of therapy to the first date of determined progressive disease	six months