Solid TumorsPhase 1SDH-CombiNCT06296056
Phase I Trial of Combined Immune Cell Therapy for Metastatic Stage IV Solid Tumors (SDH-Combi)
A Phase 1 study testing Combi in people with Solid Tumors and Metastatic, run by Seoul Hospital at 1 site in Mongolia.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Solid Tumors, Metastatic
- What is being tested?
- Combi
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteMongolia
- Study dates
- 1 Aug 2024to 8 Jun 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
Read the 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
- Being tested
- Combi
- Keywords
- immune cell therapy, dendritic cell, natural killer cell, cytotoxic T lymphocytes
- Medical subject headings
- Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CombiBiological
Biological immune cell therapy
| Study group | Role | What they receive |
|---|---|---|
| SDH-Combi | Experimental | natural killer (NK) cells and cytotoxic T lymphocytes (CTLs) Receives: Biological: Combi |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 6 months
Secondary outcomes (3)
Objective Response Rate (ORR) assessed by RECIST v1.1
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.
Measured: 6 months
Disease Control Rate (DCR) assessed by RECIST v1.1
Defined as the proportion of participants achieving CR, PR, or Stable Disease (SD). Reported as a percentage of evaluable participants.
Measured: 6 months
Change from baseline in EORTC QLQ-C30 global health status/quality of life score
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2024
- Study start1 Aug 2024
- Primary completion28 May 2025
- Study completion8 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nyamdavaa Tuul, Seoul Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06296056
- Sponsor's protocol ID
- SDH-Combi
- Other IDs
- Mongolian IRB
- Acronym
- SDH-Combi
- Status last verified
- Sep 2025
- First submitted
- 20 Feb 2024
- Last updated
- 1 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT06296056
- Acronym / sponsor ID
- SDH-Combi / SDH-Combi
- Conditions
- Solid Tumors, Metastatic
- Keywords
- immune cell therapy, dendritic cell, natural killer cell, cytotoxic T lymphocytes
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Seoul HospitalUniversity, hospital or other
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 28 May 2025 (actual)
- Study completion
- 8 Jun 2025 (actual)
- First posted
- 6 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SDH-Combi | Experimental | Biological: Combinatural killer (NK) cells and cytotoxic T lymphocytes (CTLs) |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CombiBiological immune cell therapy | Biological | SDH-Combi |
Primary outcome
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.
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.
3 secondary outcomes
Objective Response Rate (ORR) assessed by RECIST v1.1
Time frame: 6 months
Disease Control Rate (DCR) assessed by RECIST v1.1
Time frame: 6 months
Change from baseline in EORTC QLQ-C30 global health status/quality of life score
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Combi in people with Solid Tumors and Metastatic, run by Seoul Hospital at 1 site in Mongolia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mongolia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with treatment-related adverse events (AEs) (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2025.