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NCT05417750: MIZAR-001

A Phase I Study of GC101 TIL in Advanced Solid Tumors

Completed Phase 1 Last updated 10 December 2025
What this trial tests

Phase 1 trial testing TIL therapy in Tumor Infiltrating Lymphocytes in 43 participants. Completed in 30 October 2025.

Timeline
12 October 2022
Primary endpoint
30 April 2025
30 October 2025

Quick facts

Lead sponsorShanghai Juncell Therapeutics
PhasePhase 1
StatusCompleted
Study typeINTERVENTIONAL
Allocationnon randomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment43
Start date12 October 2022
Primary completion30 April 2025
Estimated completion30 October 2025
Sites1 location across China

Drugs / interventions tested

Conditions studied

Sponsor

Shanghai Juncell Therapeutics — full company profile →

Who can join

Adults 18 to 75, any sex, with Tumor Infiltrating Lymphocytes or Safety. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Recent clinical researches and technological development in TIL therapy.
    Matsueda S, Chen L, Li H, Yao H, et al · · 2024 · cited 23× · PMID 39264449 · DOI 10.1007/s00262-024-03793-4
  2. IL-2-free tumor-infiltrating lymphocyte therapy with PD-1 blockade demonstrates potent efficacy in advanced gynecologic cancer.
    Guo J, Wang C, Luo N, Wu Y, et al · · 2024 · cited 7× · PMID 38769543 · DOI 10.1186/s12916-024-03420-0
  3. Advances in Adoptive Cell Therapies in Cancer: From Mechanistic Breakthroughs to Clinical Frontiers and Overcoming Barriers.
    Rabbani SA, El-Tanani M, El-Tanani Y, Kumar R, et al · · 2025 · cited 1× · PMID 40981188 · DOI 10.3390/medsci13030190
  4. Tumor-infiltrating lymphocytes and tumor-associated macrophages in cancer immunoediting: a targetable therapeutic axis.
    Mukherjee S, Ghosh A, Chakraborty S, Basak U, et al · · 2025 · PMID 41019045 · DOI 10.3389/fimmu.2025.1655176

Verify or expand the search:

Other trials of TIL therapy

Trials testing the same drug.

Other recruiting trials for Tumor Infiltrating Lymphocytes

Currently open trials in the same condition.

Other Shanghai Juncell Therapeutics trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05417750.

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