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NCT05417750: MIZAR-001
A Phase I Study of GC101 TIL in Advanced Solid Tumors
Phase 1 trial testing TIL therapy in Tumor Infiltrating Lymphocytes in 43 participants. Completed in 30 October 2025.
30 April 2025
Quick facts
| Lead sponsor | Shanghai Juncell Therapeutics |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 43 |
| Start date | 12 October 2022 |
| Primary completion | 30 April 2025 |
| Estimated completion | 30 October 2025 |
| Sites | 1 location across China |
Drugs / interventions tested
- TIL therapy — full drug profile →
Conditions studied
- Tumor Infiltrating Lymphocytes — all drugs for Tumor Infiltrating Lymphocytes →
- Safety — all drugs for Safety →
- Advanced Solid Tumor — all drugs for Advanced Solid Tumor →
- Immunotherapy — all drugs for Immunotherapy →
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):
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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 -
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 -
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 -
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:
- PubMed search for NCT05417750
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of TIL therapy
Trials testing the same drug.
- NCT06783270 — T-cell Therapy with CRISPR PD1-edited Tumor Infiltrating Lymphocytes for Patients with Metastatic Melanoma · Phase 1 · recruiting
Other recruiting trials for Tumor Infiltrating Lymphocytes
Currently open trials in the same condition.
- NCT06828328 — A Study of GC203 TIL in PDCA (RJ) · EARLY_PHASE1 · recruiting
- NCT06488950 — A Study of TIL in Advanced Solid Tumors (DFGD) · EARLY_PHASE1 · recruiting
- NCT05087745 — A Clinical Study on TIL for the Treatment of Advanced Solid Tumors · EARLY_PHASE1 · recruiting
Other Shanghai Juncell Therapeutics trials
Trials by the same sponsor.
- NCT07294872 — A Study of TIL in Advanced Solid Tumors (CZ) · Phase 1 · not yet recruiting
- NCT07256756 — A Study of GC203 TIL in Advanced Solid Tumors (NF) · Phase 1 · not yet recruiting
- NCT06828328 — A Study of GC203 TIL in PDCA (RJ) · EARLY_PHASE1 · recruiting
- NCT06703398 — A Study of GC101 TIL in Advanced Melanoma · Phase 2 · recruiting
- NCT06473961 — A Phase Ib Study of GC101 in NSCLC · Phase 1 · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05417750 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Shanghai Juncell Therapeutics
- Last refreshed: 10 December 2025
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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