Phase I Study of Combined Immune Cell Therapy in Patients With Stage 4 Colorectal Cancer With Metastatic Lesion Who Failed Prior Standard of Care

Phase 1

Not yet recruiting

• Conditions: Metastatic Colorectal Cancer; Colorectal Cancer Stage IV
• Interventions: Biological: Combi

• Registration Number: NCT06296056
• Lead Sponsor: Nyamdavaa Tuul

Brief Summary

To evaluate the safety, immune response, and potential efficacy of combined immune cell therapy in patients with stage 4 colorectal cancer 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 colorectal cancer. 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 Timeline

• Status Verified: 2024-02
• Study First Submitted: 2024-02-20
• Study First Submitted QC: 2024-02-28
• Last Update Submitted: 2024-02-28
• Study First Posted: 2024-03-06
• Last Update Posted: 2024-03-06
• Study Start: 2024-06-01
• Primary Completion: 2025-12-01
• Study Completion: 2027-06-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Those who have been histologically or cytologically confirmed as adenocarcinoma among colorectal cancers

• Those with at least one measurable or evaliable lesion by RECIST v1.1

• Those who fail standard treatment for metastatic colorectal cancer (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 45 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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Combi	Combi	Dendritic cell+NK cell+Cytotoxic T cell

Primary Outcome Measures

Name	Time	Method
immune response	15 months	changes in concentration of cytokines
potential efficacy	15 months	RECIST v.1.1
Number of Patients with grade 1-5 adverse events and list of adverse event frequency	6 months	Adverse cases, laboratory test, vital signs, physical examination, cardiography, chest x-ray