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

Официальное название

A Phase I Clinical Study to Evaluate the Safety and Preliminary Efficacy of CDH17 CAR-T in Patients with CDH17-positive Advanced Solid Tumors

Обзор

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.

Подробное описание

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.

Вмешательства

• Биопрепарат Anti-CDH17 CAR-T cells infusion
  Subiects who meet the enrollment conditions will receive intravenous infusion of anti-CDH17 CAR-T Cells after lymphodepleting therapy.

Первичные конечные точки

• Incidence of adverse events(AE) after infusion [Срок оценки: within 52 weeks post-infusion]

Вторичные конечные точки (4)

• Objective Response Rate (ORR) [Срок оценки: within 52 weeks post-infusion]
• Concentration of CAR-T cells [Срок оценки: Days 2, 5, 8, 11, 14, 21, 28, 35 and weeks 6, 12, 18, 26, 34, 42, 52 after infusion]
• Progression-free survival(PFS) [Срок оценки: within 52 weeks post-infusion]
• Overall survival(OS) [Срок оценки: within 52 weeks post-infusion]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Sanbin Wang — Куньмин

Идентификаторы

NCT: NCT06820424 · BG-CT-22-013

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗