NCT06296056

Phase I Trial of Combined Immune Cell Therapy for Metastatic Stage IV Solid Tumors (SDH-Combi)

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
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: Seoul Hospital · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Solid Tumors
• Metastatic

Interventions

Type	Name	Description
BIOLOGICAL	Combi	Biological immune cell therapy

Timeline

• Start date: 2024-08-01
• Primary completion: 2025-05-28
• Completion: 2025-06-08
• First posted: 2024-03-06
• Last updated: 2025-10-01

Locations

1 site across 1 country: Mongolia