Clinical trial NCT06296056: Phase I Study of Combined Immune Cell Therapy in Patients With Stage 4 Colorectal Cancer With Metastatic Lesion Who Failed Prior Standard of Care
Official title: A Phase І, Single Center, Clinical Trial to Evaluate the Safety, Immune Response, and Efficacy of Combined Immune Cell Therapy in Patients With Stage 4 Colorectal Cancer With Metastatic Lesion Who Have Failed Prior Standard of Care
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
Conditions: Colorectal Cancer Stage IV
Metastatic Colorectal Cancer
Keywords: immune cell therapy
colorectal cancer
dendritic cell
natural killer cell
cytotoxic T cell
Lead sponsor: Seoul Hospital
Sponsor class: OTHER
First posted: 2024-03-06
Enrollment: 20
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Patients with grade 1-5 adverse events and list of adverse event frequency
timeFrame: 6 months
measure: immune response
timeFrame: 15 months
measure: potential efficacy
timeFrame: 15 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: