A Phase I Study of GC101 TIL in Advanced Solid Tumors

NCT05417750 | Completed Phase 1 DMC

• 1 other identifier: GC101 TIL-ST-01
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

Brief Summary

20-60 participants are expected to be enrolled for the Phase I clinical trial which is further divided into two parts: a "3+3" dose escalation study and an expanded enrollment study. The Phase I clinical trial is expected to be finished in 36 months. To be specific, the dose escalation study plans to include patients with advanced malignant solid tumors with clear pathological diagnosis, including melanoma, cervical cancer, head and neck squamous cell tumors, non-small cell lung cancer and breast cancer, etc.; while the expanded enrollment study plans to include those with melanoma, cervical cancer, and head and neck squamous cell tumors.

Conditions

Tumor Infiltrating Lymphocytes; Safety; Advanced Solid Tumor; Immunotherapy; Efficacy; Adverse Drug Event

Outcome Measures

Primary Outcomes (3)

• Maximal Tolerance Dose

  Up to Day 28

• Dose Limiting Toxicity

  Up to Day 28

• Adverse Events

  Maximum 360 days

Secondary Outcomes (5)

• Disease Assessment for Duration of Response

  Every 6 weeks for 12 months

• Disease Assessment for Disease Control Rate

  Every 6 weeks for 12 months

• Disease Assessment for Progression-Free Survival

  Every 6 weeks for 12 months

• Disease Assessment for Objective Response Rate

  Every 6 weeks for 12 months

• Quality of Life Assessment

  Every 6 weeks for 12 months

Study Arms (5)

Experimental: Cohort 1

EXPERIMENTAL

dose escalation group: participants with advanced solid tumors using cryopreserved GC101 TIL

Drug: TIL therapy

Experimental: Cohort 2

EXPERIMENTAL

participants with advanced malignant melanoma using cryopreserved GC101 TIL

Drug: TIL therapy

Experimental: Cohort 3

EXPERIMENTAL

participants with advanced NSCLC using cryopreserved GC101 TIL

Drug: TIL therapy

Experimental: Cohort 4

EXPERIMENTAL

participants with advanced HNSCC using cryopreserved GC101 TIL

Drug: TIL therapy

Experimental: Cohort 5

EXPERIMENTAL

participants with advanced cervical cancer using cryopreserved GC101 TIL

Drug: TIL therapy

Interventions

TIL therapy DRUG

A tumor sample is resected from each participant and cultured ex vivo to expand the population of autologous tumor infiltrating lymphocytes injection (GC101 TIL). After lymphodepletion, patients are infused GC101 TIL followed sintilimab.

Experimental: Cohort 1; Experimental: Cohort 2; Experimental: Cohort 3; Experimental: Cohort 4; Experimental: Cohort 5

Eligibility Criteria

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

You may qualify if:

• Patients must be ≥18 and ≤75 years of age at the time of consent.
• Patients with advanced metastatic solid tumors with clear pathological diagnosis, including melanoma, cervical cancer, head and neck squamous cell tumors, non-small cell lung cancer and breast cancer, etc.; while the expanded enrollment study plans to include those with melanoma, cervical cancer, and head and neck squamous cell tumors.
• At least one measurable target lesion even after resection, as defined by RECIST1.1.
• Lesions in previously irradiated areas (or other local therapy) should not be selected as target lesions, unless treatments was ≥3 months prior to Screening, and there has been demonstrated disease progression in that particular lesion.
• Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Patients must have an estimated life expectancy of ≥3 months.
• In the opinion of the Investigator, patients must be able to sign the ICF and complete all study-required procedures.
• Patients must have the following hematologic parameters, Coagulation functions and hepatic and renal function:
• White Blood Cell (WBC)≥2.5×10\^9/L；
• Absolute Lymphocyte Count (ANC)≥1.5×10\^9/L;
• Absolute Lymphocyte Count(ALC)≥0.7×10\^9/L;
• Platelet≥100×10\^9/L；
• International Normalized Ratio（INR）≤1.5×ULN;
• Activated Partial Thromboplastin Time（APTT）≤1.5×ULN;
• Serum Creatinine (Scr)≤1.5mg/dL (or 132.6μmol/L) or Creatinine Clearance≥60mL/min

You may not qualify if:

• Patients have not recovered from all prior therapy-related adverse events (AEs) to ≤ Grade 1 (per Common Terminology Criteria for Adverse Events \[CTCAE\] v5.0), except for alopecia or vitiligo, prior to Enrollment (tumor resection).
• Patients who have received an organ allograft or prior cell transfer therapy.
• Patients with symptomatic and/or untreated brain metastases (of any size and any number).
• Patients who are on chronic systemic steroid therapy for any reason.
• Patients who have active medical illness(es) that would pose increased risk for study participation, including: active systemic infections requiring systemic ABX, coagulation disorders, or other active major medical illnesses of the cardiovascular, respiratory, or immune system.
• Patients with systemic active infection requiring treatment, with positive blood culture or imaging evidence of infection, including active tuberculosis.
• Patients with hepatic encephalopathy, hepatorenal syndrome, Child-Pugh class B or more severe cirrhosis, or liver failure.
• Uncontrolled arterial hypertension（SBP≥160mmHg and/or DBP≥100mmHg）or any unstable cardiovascular or cerebrovascular disease in the recent 6 months of consent.
• Patients who have a left ventricular ejection fraction (LVEF) \< 50% or New York Heart Association (NYHA) functional classification Class 3 or Class 4.
• Female patients who are pregnant or breastfeeding.
• Patients who are HIV positive, positive syphilis serological test, positive COVID-19 nucleic acid test, or clinically active hepatitis A, B, and C including virus carriers.

Sponsors & Collaborators

• Shanghai Juncell Therapeutics: lead

Study Sites (1)

Chinese PLA General Hospital

Beijing, Beijing Municipality, 100039, China

Location

MeSH Terms

Conditions

Drug-Related Side Effects and Adverse Reactions

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 31, 2022
• First Posted: June 14, 2022
• Study Start: October 12, 2022
• Primary Completion: April 30, 2025
• Study Completion: October 30, 2025
• Last Updated: December 10, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)