A Clinical Research of CD70-targeted CAR-NKT Cells (CGC738) Therapy in RCC

Официальное название

A Clinical Research Evaluating the Safety and Efficacy of CD70-targeted CAR-NKT Cells (CGC738) Therapy in Subjects With Advanced Clear Cell Renal Cell Carcinoma

Обзор

This is a phase I, open-label, single-arm study conducted to evaluate the efficacy, safety and PK of CGC738 in the treatment of advanced clear cell renal cell carcinoma (ccRCC).

Подробное описание

This is a single-arm, open-label study. This study will include two parts, dose escalation phase (3+3 design) followed by a dose expansion phase. All eligible participants will receive a conditioning chemotherapy regimen of fludarabine and cyclophosphamide followed by CAR-T cell injection.

Additional patients will be enrolled in the dose expansion phase to further characterize the safety profile and evaluate the efficacy of anti-CD70 CAR-T cell injection.

Вмешательства

• Препарат CGC738
  CAR-NKT Cells treatment

Первичные конечные точки

• Percentage of Participants Experiencing Dose Limiting Toxicities (DLTs) [Срок оценки: Day 28 after CGC738 infusion]

Вторичные конечные точки (3)

• ORR [Срок оценки: Day 1 through week 56]
• DCR [Срок оценки: Day 1 through week 56]
• AEs [Срок оценки: Day 1 through week 56]

Критерии участия

Критерии включения

• 1\. Age 18 to 75 years.
• 2.ECOG 0-1 points.
• 3\. The expected survival time is more than 3 months.
• 4\. Patients with advanced ccRCC confirmed by histology or cytology to be recurrent or metastatic after at least first-line treatment.
• 5\. IHC: CD70 positive.
• 6\. At least one measurable lesion at baseline per RECIST version 1.1.
• 7\. The functions of important organs are basically normal:
• 8\. Pregnancy tests for women of childbearing age shall be negative, both men and women agreed to use effective contraception.

Критерии исключения

• 1\. Use of cell therapy within the previous one month.
• 2\. Subjects with other malignant tumors within the past 2 years, except basal or squamous skin cancer, superficial bladder cancer, and breast cancer in situ, have been completely cured and do not need follow-up treatment.
• 3\. Patients with leptomeningeal metastasis or central nervous system metastasis, and definite central nervous system underlying diseases with significant symptoms.
• 4\. Immunotherapy, targeted drug therapy or chemotherapy within 5 drug half-lives within 2 weeks before cell infusion.
• 5\. Active hepatitis B, HIV positive and HCV positive.
• 6\. Active infection or uncontrollable infection.
• 7\. Uncontrollable or significant heart disease.
• 8\. Unstable respiratory diseases, including interstitial pneumonia.
• 9\. Uncontrolled ascites and pleural effusion.
• 10.Known to have active or uncontrolled autoimmune diseases, such as Crohns disease, rheumatoid arthritis, systemic lupus erythematosus, etc.
• 11.Subjects who are using systemic steroids or steroid inhalers for treatment.
• 12.Pregnant or lactating female subjects.
• 13.Other investigators deem it unsuitable to participate in the study

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

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06870279 · CGC738-IIT-02

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗