Autologous CAR-T Cells (WD-01) for Metastatic Colorectal Cancer

NCT06675513 | Suspended Early Phase 1

• 1 other identifier: 2024-GCC-WD-01
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This is an investigator initiated trial to assess the efficacy and safety of a GCC-targeting CAR-T therapy (WD-01) in the metastatic colorectal cancer.

Conditions

CRC (Colorectal Cancer); Metastatic Colorectal Cancer

Keywords

Autologous CAR-T therapy; WD-01; Wondercel

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 WD-01 CAR-T cells.

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

Secondary Outcomes (4)

• Objective Response Rate (ORR)

  Measured between 1 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 WD-01 CAR-T cells to a maximum follow-up period of five years

Study Arms (1)

Single dose injection of WD-01

EXPERIMENTAL

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

Biological: An armored GCC targeting WD-01 CAR-T to treat cancer patients Other Name:

Interventions

An armored GCC targeting WD-01 CAR-T to treat cancer patients Other Name: BIOLOGICAL

Autologous WD-01 CAR-T therapy with Wondercel's "Warrior" armor strategy will be explored for its advantage over other armor platforms.

Single dose injection of WD-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:

• Pathologically confirmed colorectal cancer. Immunohistochemistry (IHC) assessment shows GCC expression in tumor lesions of ≥1+ in an average of over 40% of the area (evaluated by randomly selecting at least five tumor regions).
• Patients with metastatic colorectal cancer who have failed second-line treatment.
• At least one measurable extracranial lesion per RECIST version 1.1 criteria. Expected survival of ≥90 days.
• Normal function of major organs, meeting the following criteria:
• ECOG performance status of 0-1 or KPS score \>70.
• Hematology parameters meeting: Hemoglobin (HB) ≥80 g/L, Absolute Neutrophil Count (ANC) ≥1.5 × 10\^9/L, Platelets (PLT) ≥80 × 10\^9/L, Lymphocytes (LY) ≥0.5 × 10\^9/L.
• Biochemistry parameters meeting: Total Bilirubin (TBIL) ≤2.0 × ULN (upper limit of normal); ALT and AST ≤2.5 × ULN; Serum Creatinine (Cr) ≤1 × ULN, Creatinine Clearance Rate \>40 mL/min (by Cockcroft-Gault formula).
• Left ventricular ejection fraction \>55%. Women of childbearing potential must have a negative pregnancy test (serum or urine) within 7 days prior to enrollment and agree to use appropriate contraception during the study and for 8 weeks after the last CAR-T administration (women who have undergone sterilization or have been postmenopausal for at least 2 years are considered not of childbearing potential).
• Voluntary participation in the study, with signed informed consent, good compliance, and willingness to cooperate with follow-up.

You may not qualify if:

• Pregnant or lactating women. Receipt of small molecule chemotherapy, targeted agents, other investigational drugs, or monoclonal antibodies within 14 days prior to cell collection for enrollment.
• Participation in other clinical trials within 4 weeks prior to the start of this study.
• Uncontrolled hypertension that cannot be adequately managed with a single antihypertensive drug (systolic BP \>160 mmHg, diastolic BP \>100 mmHg), myocardial ischemia or infarction of grade ≥1, arrhythmia of grade ≥1 (including QT interval ≥440 ms), or cardiac insufficiency.
• Long-standing, unhealed wounds or fractures. History of substance abuse that cannot be discontinued or a history of psychiatric disorders.
• Severe intestinal adhesions, bowel obstruction, or conditions that may cause bowel perforation or abdominal wall fistula after treatment.
• Uncontrolled or active fungal, bacterial, viral, or other infections. Grade ≥2 hematologic toxicity or grade ≥3 non-hematologic toxicity at enrollment as per NCI-CTCAE version 5.0 criteria.
• Known HIV infection or active hepatitis B (HBsAg positive) or hepatitis C virus (anti-HCV positive) infection.
• Presence of indwelling catheters or drainage tubes (e.g., biliary drainage tubes or thoracic/abdominal drainage tubes or pericardial catheters). Use of specialized central venous catheters is permitted.
• Severe malnutrition (for patients \<70 years, BMI \<18.5 kg/m\^2; for patients ≥70 years, BMI \<20 kg/m\^2).
• History of severe allergic reactions to key therapeutic agents in this study (including fludarabine, cyclophosphamide, mesna, tocilizumab, and anti-infective drugs used during preconditioning).
• History of disseminated intravascular coagulation (DIC), deep vein thrombosis, or pulmonary embolism within 6 months prior to enrollment.
• History of autoimmune diseases that cause terminal organ damage or require systemic immunosuppressive/systemic disease-modifying drugs within 2 years prior to enrollment (e.g., Crohn's disease, rheumatoid arthritis, systemic lupus erythematosus).
• Any disease that may interfere with the safety or efficacy assessment of the study treatment.
• Female participants who are unwilling to use contraception from the time of consent until 6 months after completing CAR-T cell infusion.

Sponsors & Collaborators

• Wondercel Biotech (ShenZhen): lead

Study Sites (1)

Anhui Provincial Cancer Hospital

Hefei, Anhui, 710054, China

Location

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

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: November 3, 2024
• First Posted: November 5, 2024
• Study Start: May 18, 2025
• Primary Completion (Estimated): December 30, 2027
• Study Completion (Estimated): December 30, 2029
• Last Updated: May 7, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)