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

NCT ID: NCT06296056

Last Updated: 2025-10-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-01
• Study Completion Date: 2025-06-08

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.

Conditions

Solid Tumors; Metastatic

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

SDH-Combi

natural killer (NK) cells and cytotoxic T lymphocytes (CTLs)

Group Type: EXPERIMENTAL

Combi

Intervention Type: BIOLOGICAL

Biological immune cell therapy

Interventions

Combi

Biological immune cell therapy

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• Those who have been histologically or cytologically confirmed as adenocarcinoma among solid tumors
• Those with at least one measurable or evaliable lesion by RECIST v1.1
• Those who fail standard treatment for metastatic solid tumors (failure of treatment is defined as failure of not only progression of the disease or recurrence after treatment, but also unacceptable side effects or maintenance of the treatment process)
• ECOG performance status 0 or 1 person
• A person who can draw about 100 cc of whole blood for the manufacture of immune cells

• Weight: More than 50 kg for men and more than 35 kg for women
• Hb: 9.0 g/dL or higher (registerable if hemoglobin levels recover to 10.0 g/dL or higher during the screening period); however, transfusions within 7 days prior to screening to meet this standard are not allowed)
• Appropriate contraceptive regimen up to 2 months after clinical research drug administration
• A person who voluntarily decides to participate after receiving a sufficient explanation for this clinical study and agrees in writing

Exclusion Criteria

• Brain Metastasis patients who have symptoms or need treatment [However, patients with stable brain metastasis who have no symptoms and do not need treatment (excluding anticonvulsants in maintenance therapy) can register]
• A person with a systemic disease that is inappropriate to administer anticancer drugs according to the researcher's judgment
• Those with the following cardio-cerebrovascular diseases as of the time of screening
• a person who is HIV-positive
• Those determined that the researcher was not suitable for participation in this clinical study as a result of the active infection (HBV, HCV) test
• a person with acute or severe infection
• Those who have autoimmune diseases or have a history of chronic or recurrent autoimmune diseases
• Those with a history of organ transplants
• a hematopoietic stem cell transplant patient

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Seoul Hospital

OTHER

Sponsor Role: lead

Responsible Party

Nyamdavaa Tuul

Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Seoul Hospital

Ulaanbaatar, , Mongolia

Countries

Mongolia

Other Identifiers

Mongolian IRB

Identifier Type: OTHER

Identifier Source: secondary_id

SDH-Combi

Identifier Type: -

Identifier Source: org_study_id