Safety and Preliminary Efficacy of Anti-CDH17 CAR-T Cell Therapy in Patients with CDH17-positive Advanced Solid Tumors

The 920th Hospital of The Joint Logistics Support Force of the Chinese People's Liberation Army

Status and phase

Enrolling

Early Phase 1

Conditions

CDH17-positive Advanced Solid Tumors

Treatments

Biological: Anti-CDH17 CAR-T cells infusion

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT06820424

BG-CT-22-013

Details and patient eligibility

About

This is a single-center, open-label, single-arm study to evaluate the safety and preliminary efficacy of anti-CDH17 CAR-T cells in patients with CDH17-positive advanced solid tumors.

Full description

This is a single-center, open-label, single-arm study to evaluate the safety and preliminary efficacy of anti-CDH17 CAR-T cells in patients with CDH17-positive advanced solid tumors.A leukapheresis procedure will be performed to manufacture Anti-CDH17 chimeric antigen receptor (CAR) modified T cells. Prior to Anti-CDH17 CAR-T cells infusion subjects will receive lymphodepleting therapy with fludarabine and cyclophosphamide. After infusion, the safety and efficacy of CAR-T therapy was evaluated by investigators.

Enrollment

30 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

The patient understands and voluntarily signs the informed consent form, and is expected to complete the follow-up examination and treatment of the study procedures;
Age 18-75 years old, gender unlimited;
Tumor patients who have positive expression of CDH17 target in tumor tissues measured by immunohistochemistry (IHC) in a laboratory approved by the partner, and have no standard therapy or are ineffective or not suitable for standard treatment;
Have at least one extracranial measurable lesion according to RECIST 1.1 criteria;
Estimated survival ≥ 12 weeks;
Baseline ECOG (Eastern Cooperative Oncology Group) score ≤ 1 point;
The patient has recovered from the toxicity of the prior treatment, i.e., CTCAE toxicity grade < 2 (unless the abnormality is related to the tumor or is stable as judged by the investigator and has little impact on safety or efficacy);
Venous access could be established; without contraindications of apheresis.

Exclusion criteria

Patients with prior or current other malignancies;
Presence of brain metastases and clinically significant central nervous system disease;
Prior antitumor therapy (prior to blood collection for CAR-T preparation) : targeted therapy, epigenetic therapy, or investigational drug therapy within 14 days or at least 5 half-lives, whichever is shorter;
Subjects with positive HBsAg or HBcAb positive and peripheral blood HBV DNA titer is higher than the lower limit of detection of the research institution; HCV antibody positive; HIV antibody positive; CMV DNA titer is higher than the lower limit of detection of the research institution; EBV DNA titer is higher than the lower limit of detection of the research institution
Those who have a positive sputum smear and T-cell test for tuberculosis infection;
Patients with objective evidence of a history of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-related pneumonia, and severe impairment of lung function, both past and present;
Patients have a severe allergic history;
Patients with severe heart disease or uncontrollable refractory hypertension;
Patients with severe liver and kidney dysfunction or consciousness disorders;
Active autoimmune or inflammatory diseases of the nervous system;
Uncontrolled infections that need antibiotics treatment;
Live attenuated vaccine within 4 weeks before screening;
Alcoholics or persons with a history of drug abuse;
Pregnant or Lactating Women; Patients and his or her spouse have a fertility plan within two years after CAR-T cell infusion;
Any unsuitable to participate in this trial judged by the investigator.