Ignite Creation Date:
2025-12-24 @ 11:25 PM
Ignite Modification Date:
2025-12-25 @ 9:10 PM
Study NCT ID:
NCT06296056
Status:
COMPLETED
Last Update Posted:
2025-10-01
First Post:
2024-02-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Phase I Trial of Combined Immune Cell Therapy for Metastatic Stage IV Solid Tumors (SDH-Combi)
Sponsor:
Seoul Hospital
Organization:
Study Overview
Official Title:
Single-center, Phase 1 Clinical Trial Evaluating the Safety and Preliminary Efficacy of a Combination Cellular Immunotherapy in Patients With Metastatic (Stage IV) Solid Tumors Refractory to standard-of Care Therapies.
Status:
COMPLETED
Status Verified Date:
2025-09
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:
SDH-Combi
Brief Summary:
To evaluate the safety and potential efficacy of combined immune cell therapy in patients with stage IV solid tumors who have failed standard treatment and have unresectable lesions or metastatic lesions.
Detailed Description:
The combined immune cell therapy has a strong potential to improve treatment outcomes in several cancers, but problems related to manufacturing complexity, immunocompatibility, and poteintial toxicity may also arise. This clinical study was designed to address these challenges and to establish the safety and potential efficacy of combined immune cell therapy for unresectable solid tumors. This is a phase I study to evaluate the safety and potential efficacy of combined immune cell theapy, and obtain the recommended dose and infusion plan.
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| Mongolian IRB | OTHER | 24/094 | View |