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

NCT06296056 | Completed Phase 1 DMC

• 2 other identifiers: SDH-CombiMongolian IRB
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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.

Conditions

Solid Tumors; Metastatic

Keywords

immune cell therapy; dendritic cell; natural killer cell; cytotoxic T lymphocytes

Outcome Measures

Primary Outcomes (2)

• Number of participants with treatment-related adverse events (AEs)

  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)

  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 Outcomes (3)

• Objective Response Rate (ORR) assessed by RECIST v1.1

  6 months

• Disease Control Rate (DCR) assessed by RECIST v1.1

  6 months

• Change from baseline in EORTC QLQ-C30 global health status/quality of life score

  6 months

Study Arms (1)

SDH-Combi

EXPERIMENTAL

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

Biological: Combi

Interventions

Combi BIOLOGICAL

Biological immune cell therapy

SDH-Combi

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul Hospital: lead

Study Sites (1)

Seoul Hospital

Ulaanbaatar, Mongolia

Location

MeSH Terms

Conditions

Neoplasm Metastasis

Interventions

beriplast P combi set

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: February 20, 2024
• First Posted: March 6, 2024
• Study Start: August 1, 2024
• Primary Completion: May 28, 2025
• Study Completion: June 8, 2025
• Last Updated: October 1, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

MO (1)