Clinical Study on the Safety and Preliminary Efficacy of CDH17/GUCY2C CAR-T in the Treatment of Patients With Advanced Colorectal Cancer

NCT07152210 | Recruiting

• 1 other identifier: CF-24-008
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a single-arm, single-center investigator-initiated trial (IIT) designed to evaluate the safety and preliminary efficacy of CDH17/GUCY2C CAR-T cell therapy in patients with advanced colorectal cancer, as well as to assess its pharmacodynamic (PD) and pharmacokinetic (PK) profiles.

Conditions

Colorectal Cancer (CRC)

Keywords

Colorectal cancer

Outcome Measures

Primary Outcomes (2)

• Evaluation of Safety

  Count the Incidence of adverse events

  Up to 1 year after CAR-T infusion

• Effectiveness evaluation

  In accordance with the RECIST 1.1 criteria for assessing the efficacy of solid tumors, the objective response rate (ORR), encompassing patients achieving complete response (CR) and partial response (PR).

  Up to 1 years after CAR-T infusion

Secondary Outcomes (2)

• Pharmacokinetic parameters

  Up to 1 year after CDH17/GUCY2C CAR-T infusion

• Pharmacodynamic parameters

  Up to 1 year after CAR-T infusion

Study Arms (1)

CAR-T

EXPERIMENTAL

The dosage range of 1.0 × 10\^6/kg (± 20%) to 5.0 × 10\^6/kg (± 20%) of CAR-T cells, administered either intravenously or intratumorally.

Biological: CAR-T

Interventions

CAR-T BIOLOGICAL

Eligible subjects who successfully passed screening will receive CAR-T cell infusion on Day 0 after lymphodepleting preconditioning chemotherapy.

CAR-T

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Voluntarily participate in this trial, sign the informed consent form.
• Advanced colorectal cancer patients who have either failed standard treatment, experienced intolerable toxicity, or are unsuitable or unwilling to undergo standard treatment, and voluntarily agree to receive the current treatment.
• Be able to provide immunohistochemical (IHC) test results from the past 2 years, indicating positive expression of CDH17/GUCY2C targets in tumor tissues.
• Have at least one extracranial, measurable/assessable lesion according to RECIST 1.1 criteria.
• Have an ECOG (Eastern Cooperative Oncology Group) performance status score of 0-1 and an expected survival duration of at least 3 months.
• Have recovered from the toxicity associated with previous treatments, with a CTCAE toxicity grade of less than 2.
• Have no significant hematopoietic dysfunction and possess adequate organ function.
• Be able to meet the research center's requirements for apheresis/peripheral blood collection upon successful screening, or have acceptable stored blood cell separation products available.

You may not qualify if:

• Patients who have had or currently have other malignant tumors within the past five years.
• Presence of brain metastasis.
• History of clinically significant central nervous system disorders, either in the past or at screening.
• Imaging indicating tumor invasion of major blood vessels or indistinct borders with blood vessels.
• Individuals who have received cytotoxic drugs or other interventions, assessed by the investigator as potentially impacting lymphocyte expansion, within 14 days or at least five half-lives (whichever is shorter) prior to blood collection for CAR-T preparation.
• Presence of other viremias.
• History of severe allergies.
• Patients with severe cardiac disease.
• Patients with severe hepatic and renal dysfunction or disorders of consciousness.
• Patients with active autoimmune or inflammatory diseases.
• Patients with objective evidence of past or current pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-induced pneumonia, severe lung function impairment, etc.
• Patients who have undergone or are awaiting organ transplantation.
• Infections requiring intravenous antibiotic therapy for control or are uncontrollable.
• Individuals who have received live (attenuated) virus vaccines within four weeks prior to screening.
• Alcoholics or individuals with a history of substance abuse.

Sponsors & Collaborators

• Guangzhou Bio-gene Technology Co., Ltd: lead

Study Sites (1)

Dongguan Taixin Hospital

Dongguan, Guangdong, 523125, 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

Xiaohu Hao, Ph.D. degree

CONTACT

0762-33335678; jiancong.liu@gobroadhealthcare.com

Chunfu Li, Ph.D. degree

CONTACT

+86 18617895379

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2025
• First Posted: September 3, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: September 3, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)