A Clinical Study on TIL for the Treatment of Advanced Solid Tumors

NCT05087745 | Recruiting Early Phase 1

• 1 other identifier: GC101-ZJ01
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

This study is to investigate the safety and efficacy of tumor infiltrating lymphocyte (TIL) therapy in patients with advanced solid tumors. Autologous TILs are expanded from tumor resections or biopsies and infused i.v. into the patient after NMA lymphodepletion treatment with hydroxychloroquine(600mg,single-dose) and cyclophosphamide.

Conditions

Advanced Solid Tumor; Tumor Infiltrating Lymphocytes; Treatment Side Effects; Effects of Immunotherapy

Outcome Measures

Primary Outcomes (6)

• Adverse Events

  To characterize the safety profile of GC101 (TIL) in patients with recurrent, metastatic, or persistent solid tumors as assessed by incidence of adverse events.

  6 months

• Objective Response Rate (ORR)

  Proportion of patients with response per Response Evaluation Criteria in Solid Tumors (RECIST v1.1): ORR (proportion of patients) = # with CR + # with PR / # with CR + # with PR + # with SD + # with PD. ( Except baseline evaluation within 28 days before TIL infusion，PET/CT scan will be performed at 6 weeks after TIL infusion, and than every 6 weeks for 6 months, and then every 6 months after that for up to 3 years)

  Up to 36 months

• Disease Control Rate (DCR）

  Percentage of patients that meet CR, PR and SD criteria set in this study according to RECIST v1.1： DCR (proportion of patients) = # with CR + # with PR + # with SD / # with CR + # with PR + # with SD + # with PD.

  Up to 36 months

• Duration of Response (DOR)

  The time length between the first confirmed objective response per RECIST 1.1 to the treatment and the subsequent disease progression per RECIST 1.1

  Up to 36 months

• Progression-Free Survival (PFS)

  The time length between TIL infusion and confirmed subsequent disease progression according to RECIST 1.1

  Up to 36 months

• Overall Survival (OS)

  The length of time from the date of the start of TIL treatment that the patients are still alive

  Up to 36 months

Secondary Outcomes (1)

• Change in Quality of Life

  Up to 36 months

Study Arms (1)

Tumor Infiltrating Lymphocytes

EXPERIMENTAL

1x10\^9-5x10\^10 in vitro expanded autologous TILs will be infused i.v. to patients with advanced solid tumors after NMA lymphodepletion treatment with hydroxychloroquine(600mg,single-dose) and cyclophosphamide.

Biological: Tumor Infiltrating Lymphocytes

Interventions

Tumor Infiltrating Lymphocytes BIOLOGICAL

Adoptive transfer of 1x10\^9-5x10\^10 autologous TILs to patients i.v. in 30-120 minutes.

Tumor Infiltrating Lymphocytes

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: 18 years to 75 years;
• Histologically diagnosed as primary/relapsed/metastasized solid tumors ;
• Expected life-span more than 3 months;
• Karnofsky≥60% or ECOG score 0-2;
• Test subjects have failed standard treatment regimens, or there are no standard treatment regimens available.
• Test subjects must have tumor regions eligible for biopsy or resection, or malignant body fluid where TILs can be isolated;
• At least 1 evaluable tumor lesion;
• Hematology and Chemistry（within 7 days prior to enrollment）:
• Absolute count of white blood cells≥2.5×10\^9/L;
• Absolute count of neutropils≥1.5×10\^9/L;
• Absolute count of lymphocytes ≥0.7×109/L；
• Platelet count≥100×10\^9；
• hemoglobin≥90 g/L;
• Activated partial thromboplastin time (APTT) ≤1.5xULN (Unless received anticoagulant therapy within the previous 3 days);
• International normalized ratio (INR) ≤1.5xULN (Unless received anticoagulant therapy within the previous 3 days);

You may not qualify if:

• Need glucocorticoid treatment, and daily dose of Prednisone greater than 15mg (or equivalent doses of hormones) or outoimmune diseases requiring immunomodulatory treatment;
• Forced expiratory volume in one second (FEV1) less than 2L, diffusing capacity of the lung for carbon monoxide (DLCO) (calibrated) less than 40%;
• Significant cardiovascular anomalies according to any of the following definition: New York Heart Association (NYHA) Grade III or IV congestive heart failure, clinically significant low blood pressure, uncontrollable symptomatic coronary artery diseases, or ejection fraction less than 35%; Severe cardiac rhythm and conduction anomaly, such as ventricular arrhythmia requiring clinical intervention, second-third degree atrio-ventricular conductive block, etc.
• Human immunodeficiency virus (HIV) infection or anti-HIV antibody positive, active HBV or HCV infection (HBsAg positive and/or anti-HCV positive), syphilis infection or Treponema pallidum antibody positive;
• Severe physical or mental diseases;
• Have a systemic active infection requiring treatment, or have positive blood cultures(or imaging evidence of infection);
• Having been treated within a month or being treated now with other medicines, or other biologic therapy, chemo-or radiotherapy;
• History of allergy to chemical compound consisting of chemical and biologic substances resembling cell therapy;
• Having received immunotherapy and developed irAE level greater than Level 3;
• Previous anti-tumor treatment AE did not return to CTCAE5.0 version grade 1 or below (toxicity considered by the investigator as non-safety concerns like alopecia excluded);
• Females in pregnancy or lactation;
• History of organ transplantation, allogeneic stem cell transplantation, and renal replacement therapy;
• Researchers considering the test subject as having a history of other severe systemic diseases, or other reasons inappropriate for the clinical study.

Sponsors & Collaborators

• Shanghai Juncell Therapeutics: lead
• Sir Run Run Shaw Hospital: collaborator

Study Sites (1)

Sir Run Run Shaw Hospital, Zhejiang University, School of Medicine

Hangzhou, Zhejiang, 310016, China

RECRUITING

Central Study Contacts

Clinical GC

CONTACT

086-18001759113; clinicaltrails@juncell.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2021
• First Posted: October 21, 2021
• Study Start: December 10, 2021
• Primary Completion: December 10, 2024
• Study Completion: December 10, 2025
• Last Updated: April 17, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)