Universal CAR-T Cells (REVO-UWD-01) for Metastatic Colorectal Cancer

NCT06653010 | Recruiting Early Phase 1

• 1 other identifier: 2024-REVO-UWD-01
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

CRC (Colorectal Cancer); Metastatic Colorectal Cancer

Keywords

Universal CAR-T cells; Allogeneic CAR-T therapy; Wondercel REVO U-CAR platform; REVO-UWD-01

Outcome Measures

Primary Outcomes (3)

• Maximum Tolerated Dose (MTD)

  The highest dose of GCC-CAR-T cells that can be administered without causing unacceptable side effects, measured during the dose escalation phase.

  Within the first month post-infusion.

• Dose-Limiting Toxicities (DLT)

  The incidence of treatment-related toxicities that prevent further dose escalation.

  Within the first month post-infusion.

• Treatment-Emergent Adverse Events (TEAE)

  The frequency and severity of adverse events that arise following the administration of UWD-01-CAR-T cells.

  From the administration of UWD-01 CAR-T cells through six months post-infusion

Secondary Outcomes (4)

• Objective Response Rate (ORR)

  Measured at 3 and 6 months after treatment.

• Progression-Free Survival (PFS)

  From the start of treatment up to 5 years.

• Overall Survival (OS)

  From the start of treatment up to maximum follow-up period of five years.

• Duration of Response (DOR)

  From the administration of UWD-01 CAR-T cells to a maximum follow-up period of five years.

Study Arms (1)

Single dose injection of REVO-UWD-01

EXPERIMENTAL

Dose escalation will be performed for the single dose injection of REVO-UWD-01 for treating mCRC

Biological: Universal CAR-T cells injection for treating mCRC

Interventions

Universal CAR-T cells injection for treating mCRC BIOLOGICAL

A novel universal CAR-T platform to treat cancer patients

Also known as: Allogeneic CAR-T cells (REVO-UWD-01)

Single dose injection of REVO-UWD-01

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• Absolute neutrophil count ≥1.5 × 10⁹/L;
• Platelet count ≥80 × 10⁹/L;
• Hemoglobin ≥9 g/dL;
• Liver function:
• Total bilirubin ≤1.5 × ULN (≤2.0 × ULN for Gilbert's syndrome);
• AST and ALT ≤5 × ULN;
• INR \<1.3 (INR \<3 for participants on anticoagulant therapy);

You may not qualify if:

• 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;
• 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);
• Uncontrolled arrhythmias (e.g., atrial fibrillation, ventricular tachycardia) or requiring long-term anti-arrhythmic therapy;
• QTcF \>480 ms on screening ECG;
• Uncontrolled hypertension (systolic BP \>160 mmHg or diastolic BP \>100 mmHg);
• History of ischemic or hemorrhagic stroke (unless stable for \>6 months with no sequelae);
• Uncontrolled intracranial lesions (e.g., brain tumors, aneurysms);
• History of DVT or PE (unless on stable anticoagulant therapy for ≥6 months);
• Significantly elevated troponin or BNP/NT-proBNP levels suggestive of potential cardiac injury or dysfunction;
• Non-healing wounds or fractures for a prolonged period;

Sponsors & Collaborators

• Wondercel Biotech (ShenZhen): lead

Study Sites (2)

Shenzhen Nanshan People's Hospital

Shenzhen, Guangdong, China

RECRUITING

First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, 710061, China

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Central Study Contacts

Clinical Deveopment Director

CONTACT

86-18092039190; clinical@wondercel.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 17, 2024
• First Posted: October 22, 2024
• Study Start: October 23, 2024
• Primary Completion (Estimated): October 20, 2027
• Study Completion (Estimated): December 30, 2027
• Last Updated: January 16, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)