A Study of TIL in Advanced Solid Tumors (CZ)

Sponsor
Shanghai Juncell Therapeutics
Study ID
NCT07294872
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

  • Solid Tumor, Adult

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • GC101TIL — BIOLOGICAL
    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.

Study Details

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.

Key Dates

First listed
Dec 19, 2025
Start date
Dec 8, 2026
Status verified
Dec 2025
Primary completion
Sep 20, 2027
Completion
Sep 20, 2029

Study Design

Enrollment
30 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.
  • 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.

Primary Outcome Measure

Adverse Events [ Time Frame: 6 month ]

Central Contacts

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