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Trial Title:
Phase I Study of Combined Immune Cell Therapy in Patients With Stage 4 Colorectal Cancer With Metastatic Lesion Who Failed Prior Standard of Care
NCT ID:
NCT06296056
Condition:
Colorectal Cancer Stage IV
Metastatic Colorectal Cancer
Conditions: Official terms:
Colorectal Neoplasms
Conditions: Keywords:
immune cell therapy
colorectal cancer
dendritic cell
natural killer cell
cytotoxic T cell
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Biological
Intervention name:
Combi
Description:
Biological immune cell therapy
Arm group label:
Combi
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.
Criteria for 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
Gender:
All
Minimum age:
19 Years
Maximum age:
N/A
Healthy volunteers:
No
Start date:
June 1, 2024
Completion date:
June 1, 2027
Lead sponsor:
Agency:
Nyamdavaa Tuul
Agency class:
Other
Source:
Seoul Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06296056
