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Not yet recruitingNCT07294872Updated Aug 5, 2026

A Study of TIL in Advanced Solid Tumors (CZ)

A Phase 1 interventional study of GC101TIL in Solid Tumor, Adult, sponsored by Shanghai Juncell Therapeutics. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-08-05.

Sponsored by Shanghai Juncell Therapeutics · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
30
Allocation
Non-randomized
Ages
18 Years to 70 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Solid Tumor, Adult
03

In context

Lead sponsor

Shanghai Juncell Therapeutics is the lead sponsor of 19 studies on the registry; 16 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • have one the tumor resection for TILs production and successfully produced；
  • Age: 18 years to 75years;
  • Histologically diagnosed as solid tumors;
  • Expected life-span more than 3 months;
  • ECOG score 0-1;
  • Test subjects have failed standard treatment regimens, and be willing to receive TIL therapy;
  • At least 1 evaluable tumor lesion;

Exclusion criteria

Exclusion Criteria:

  • with other malignant tumors, except for the malignancies that have been cured, have been inactive for ≥5 years prior to study inclusion and have a very low risk of recurrence; Non-melanoma skin cancer or malignant lentigo with adequate treatment and no evidence of disease recurrence; Carcinoma in situ with adequate treatment and no evidence of disease recurrence;
  • Need glucocorticoid treatment, and daily dose of Prednisone greater than 10mg(or equivalent doses of hormones) or outoimmune diseases requiring immunomodulatory treatment;
  • Breathe indoor air in a quiet state, and the oxygen saturation of finger pulse is \< 95%;
  • 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;
  • Significant cardiovascular anomalies
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    Arm B

    GC101 TILs will be infused i.v. to patients with advanced solid tumors after NMA lymphodepletion treatment with hydroxychloroquine(600mg,single-dose) and cyclophosphamide.

    Biological: GC101TIL

  • Experimental
    Arm A

    GC203 TILs will be infused i.v. to patients with advanced solid tumors after NMA lymphodepletion treatment with hydroxychloroquine(600mg,single-dose) and cyclophosphamide.

    Biological: GC101TIL

Interventions

  • BiologicalGC101TIL

    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.

06

What researchers measure

Primary outcomes

  1. Adverse Events

    To characterize the safety profile of GC101 TIL in patients with pancreatic ductal adenocarcinoma who were failed to standard treatment as assessed by incidence of adverse events.

    Time frame: 6 month

Secondary outcomes

  1. Objective Response Rate (ORR)

    Proportion of patients with response per Response Evaluation Criteria in Solid Tumors (RECIST v1.1)

    Time frame: Up to 36 months

  2. Disease Control Rate (DCR）

    Proportion of patients with response per Response Evaluation Criteria in Solid Tumors (RECIST v1.1)

    Time frame: Up to 36 months

  3. 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

    Time frame: Up to 36 months

  4. Progression-Free Survival (PFS)

    The time from TIL infusion until disease progression or death from any cause.

    Time frame: Up to 36 months

  5. Overall Survival(OS)

    The time from TIL infusion until death from any cause.

    Time frame: Up to 36 months

07

Study locations

1 site
  • Sichuan Cancer Hospital & Institute, Sichuan Cancer Center
    Chengdu, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 5, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07294872
Lead sponsor
Shanghai Juncell Therapeutics
Collaborators
Sichuan Cancer Hospital and Research Institute
Responsible party
Sponsor
First posted
Dec 19, 2025
Start date
Dec 8, 2026 (estimated)
Primary completion
Sep 20, 2027 (estimated)
Completion
Sep 20, 2029 (estimated)
Last update
Aug 5, 2026

Study contacts

Ying Cheng
Contact
ying.cheng@juncell.com
+8621-69110327
Huangming Hong
principal investigator · Sichuan Cancer Hospital & Institute, Sichuan Cancer Center

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.

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