Universal CAR-T Cells (REVO-UWD-01) for Metastatic Colorectal Cancer (NCT06653010) | Clinical Trial Compass
SuspendedEarly Phase 1
Universal CAR-T Cells (REVO-UWD-01) for Metastatic Colorectal Cancer
Stopped: Because the implementation of the new regulation policy by the Chinese authority
China30 participantsStarted 2024-10-23
Plain-language summary
This is an investigator initiated trial to assess the efficacy and safety of a GCC-targeting CAR-T therapy (REVO-UWD-01) in the metastatic colorectal cancer. It also aims to explore the feasibility of using a novel universal CAR-T cell platform.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. Age: ≥18 years and ≤75 years old.
✓. Pathological Diagnosis: Pathologically confirmed metastatic colorectal cancer with radiographically confirmed metastatic lesions (e.g., CT or MRI).
✓. GCC Expression: Tumor lesions assessed by immunohistochemistry (IHC) showing GCC expression ≥1+ in ≥50% of the area (randomly select at least 5 fields from tumor regions for evaluation; at least 5 unstained slides must be provided for assessment).
✓. Measurable Lesions: At least one measurable lesion per RECIST 1.1 criteria; measurable lesions should not have received prior radiotherapy or interventional local therapy (lesions in previously irradiated or locally treated fields may be selected as target lesions if confirmed to have progressed).
✓. Prior Treatment: Participants with advanced colorectal cancer who have progressed or are intolerant after ≥2 lines of standard therapy (with clear documentation).
✓. ECOG Performance Status: 0 or 1.
✓. Expected Survival: ≥90 days (as assessed by the investigator based on the participant's clinical condition).
✓. Organ Function:
Exclusion criteria
✕. • Pregnant or breastfeeding women;
✕. • Received chemotherapy, targeted therapy, monoclonal antibody therapy, or traditional Chinese medicine anti-tumor therapy within 14 days prior to cell collection;
✕
What they're measuring
1
Maximum Tolerated Dose (MTD)
Timeframe: Within the first month post-infusion.
2
Dose-Limiting Toxicities (DLT)
Timeframe: Within the first month post-infusion.
3
Treatment-Emergent Adverse Events (TEAE)
Timeframe: From the administration of UWD-01 CAR-T cells through six months post-infusion
. • Participated in another drug clinical trial within 4 weeks prior to study initiation;
✕. • Any of the following cardiovascular or cerebrovascular diseases or risk factors:
✕. LVEF \<50%;
✕. NYHA Class III or IV heart failure;
✕. History of myocarditis, cardiomyopathy, or myocardial infarction within 6 months prior to enrollment (unless cardiac function has recovered as confirmed by the investigator);