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

September 25, 2025 updated by: Nyamdavaa Tuul, Seoul Hospital

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

9

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mongolia
      • Ulaanbaatar, Mongolia
        • Seoul Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SDH-Combi
natural killer (NK) cells and cytotoxic T lymphocytes (CTLs)
Biological: Combi
Biological immune cell therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with treatment-related adverse events (AEs)
Time Frame: 6 months
All AEs will be collected and graded according to NCI-CTCAE v5.0. Data will be reported as the number and percentage of participants experiencing ≥1 AE.
6 months
Number of participants with serious adverse events (SAEs)
Time Frame: 6 months
SAEs will be assessed for type, severity, and relationship to the investigational product. Reported as the number and percentage of participants experiencing ≥1 SAE.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective Response Rate (ORR) assessed by RECIST v1.1
Time Frame: 6 months
Defined as the proportion of participants with Complete Response (CR) or Partial Response (PR) according to RECIST v1.1. Reported as a percentage of evaluable participants.
6 months
Disease Control Rate (DCR) assessed by RECIST v1.1
Time Frame: 6 months
Defined as the proportion of participants achieving CR, PR, or Stable Disease (SD). Reported as a percentage of evaluable participants.
6 months
Change from baseline in EORTC QLQ-C30 global health status/quality of life score
Time Frame: 6 months
Change from baseline to 6 months in the global health status/QoL domain of the EORTC QLQ-C30 questionnaire (0-100 scale; higher score indicates better outcome). Reported as mean change from baseline with standard deviation.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2024

Primary Completion (Actual)

May 28, 2025

Study Completion (Actual)

June 8, 2025

Study Registration Dates

First Submitted

February 20, 2024

First Submitted That Met QC Criteria

February 28, 2024

First Posted (Actual)

March 6, 2024

Study Record Updates

Last Update Posted (Estimated)

October 1, 2025

Last Update Submitted That Met QC Criteria

September 25, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SDH-Combi
  • Mongolian IRB (Other Identifier: 24/094)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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