A Clinical Study of CHT101 in CD70-Positive Relapsed or Refractory Hematological Malignancies

Официальное название

A Phase 1, Open-Label, Single-Arm Study of the Safety, Pharmacokinetics and Efficacy of CHT101 in Subjects With Relapsed or Refractory T or B Cell Hematological Malignancies

Обзор

Evaluate the Safety, Pharmacokinetics and Efficacy of CHT101 in Subjects With Relapsed or Refractory T or B Cell Hematological Malignancies

Подробное описание

3 planned dose cohorts will be evaluated during dose escalation phase. The dose expansion will be initiated after SRC (safety review committee) reviewing available safety, PK and preliminary efficacy data.

Вмешательства

• Препарат CHT101
  CD70 UCAR-T

Первичные конечные точки

• Dose-limiting toxicity (DLT) [Срок оценки: 28 days of first infusion of CHT101]
• Maximum tolerated dose (MTD) [Срок оценки: 28 days of first infusion of CHT101]

Вторичные конечные точки (7)

• Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 [Срок оценки: 2 years]
• Objective response rate (ORR) [Срок оценки: 2 years]
• Duration of response (DOR) [Срок оценки: 2 years]
• Progression-free survival (PFS) [Срок оценки: 2 years]
• Overall survival (OS) [Срок оценки: 2 years]
• Pharmacokinetics (PK) [Срок оценки: 2 years]
• Pharmacodynamics (PD) [Срок оценки: 2 years]

Критерии участия

Inclusion Criteria (abbreviated):

• Willing and able to provide written informed consent.
• Aged 18 to 70 years, male or female.
• Confirmed CD70 positive in tumor tissue by immunohistochemistry (IHC).
• Only the following subtypes of hematological malignancies with measurable disease will be enrolled:

• Peripheral T cell lymphoma (including peripheral T cell lymphoma NOS, angioimmunoblastic T cell lymphoma, anaplastic large cell lymphoma, etc.) who have failed ≥1 line of systemic therapy.
• Cutaneous T cell lymphoma (including mycosis fungoides (MF) or Sézary syndrome (SS) \[stage ≥IIB with disease involving two or more compartments or single-compartment disease with large-cell transformation\]) who have failed ≥2 lines of systemic therapies.
• Aggressive B cell lymphoma who are refractory or relapsed post ≥2 lines of systemic therapies which contain anti-CD20 antibody and anthracyclines.
• Indolent B cell lymphoma who are refractory or relapsed post ≥2 lines of systemic therapies which contain anti-CD20 antibody.
• Chronic lymphocytic leukemia (CLL) who are refractory or relapsed post ≥2 lines of systemic therapies which contain BTK inhibitor and BCL-2 inhibitor.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
• Estimated life expectancy ≥12 weeks.
• Female patients of childbearing potential and male patients must agree to use a highly effective method of contraception from signing ICF through 2 years after last CHT101 infusion.

Exclusion Criteria (abbreviated):

• History or presence of CNS metastasis, or clinically relevant CNS pathology such as seizure, stroke, severe brain injury, etc.
• History of solid organ transplantation.
• Prior treatment with CD70-targeting agents.
• Prior treatment with CAR-T or other cellular/gene therapies.
• Ongoing bacterial, viral or fungal infection requiring systemic anti-infectives.
• Active autoimmune disease requiring immunosuppression.

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

• Tianjin Medical University Cancer Institute & Hospital — Тяньцзинь

Идентификаторы

NCT: NCT06914037 · CHT101HIIT-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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