Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| Mongolian IRB | Other Identifier | 24/094 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SDH-Combi | Experimental | natural killer (NK) cells and cytotoxic T lymphocytes (CTLs) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Combi | Biological | Biological immune cell therapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 months |
| Disease Control Rate (DCR) assessed by RECIST v1.1 |
Not provided
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
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:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul Hospital | Ulaanbaatar | Mongolia |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D009385 | Neoplastic Processes |
| D009369 | Neoplasms |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| C586540 | beriplast P combi set |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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 | 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 |