Ignite Creation Date:
2025-12-24 @ 5:08 PM
Ignite Modification Date:
2026-02-25 @ 7:08 PM
Study NCT ID:
NCT05417750
Status:
COMPLETED
Last Update Posted:
2025-12-10
First Post:
2022-05-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase I Study of GC101 TIL in Advanced Solid Tumors
Sponsor:
Shanghai Juncell Therapeutics
Organization:
Study Overview
Official Title:
An Open-label, Single-arm, Phase I Study to Evaluate the Safety and Efficacy of Autologous Tumor Infiltrating Lymphocytes Injection in Patients With Advanced Malignant Solid Tumors
Status:
COMPLETED
Status Verified Date:
2025-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MIZAR-001
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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: