KSV01 Injection for the Treatment of Relapsed/Refractory Diffuse Large B-Cell Lymphoma

Официальное название

A Phase I Clinical Study on the Safety, Tolerability, and Efficacy of KSV01 Injection in Patients With Relapsed/Refractory Diffuse Large B-cell Lymphoma

Обзор

This is a single center, single arm, open-label, dose escalation, phase 1 study to evaluate the safety, tolerability and preliminary efficacy of KSV01 Injection for patients with diffuse large B-cell lymphoma.

Вмешательства

• Препарат KSV01 Injection
  KSV01 Injection is one kind of third-generation non-replicative self-inactivating lentivirus vector which carries CD19 CAR.

Первичные конечные точки

• Dose-limiting Toxicity [Срок оценки: 28 days after administration]

Критерии участия

Критерии включения

• Patients or their legal guardians voluntarily participate in the study and provide written informed consent.
• Aged 18 to 80 years (inclusive), male or female.
• ECOG performance status score of ≤ 1.
• Life expectancy > 3 months.
• KPS score ≥ 70.
• Patients with diffuse large B-cell lymphoma (DLBCL) diagnosed according to the 2016 WHO classification. Patients with DLBCL should have been diagnosed as relapsed or refractory after at least one prior line of systemic therapy.
• CD19 positivity confirmed by flow cytometry and/or histopathology.
• According to the Lugano 2014 criteria, the presence of PET-positive target lesions for tumor assessment is required (Deauville 5-Point Scale \[5-PS\] ≥ 4).
• Adequate organ function.
• Female patients of childbearing potential must have a negative urine/blood pregnancy test during the screening period and agree to use effective contraception for at least 1 year after infusion; male subjects with partners of childbearing potential must agree to use effective barrier contraception for at least 1 year after infusion.

Критерии исключения

• History of another primary malignancy that has not been in continuous remission for at least 2 years, except for the following conditions which are exempt from the 2-year limit: non-melanoma skin cancer, Stage I solid tumors treated with curative intent and low risk of recurrence, cured localized prostate cancer, biopsy-confirmed carcinoma in situ of the cervix, or squamous intraepithelial lesion identified on Pap smear.
• Uncontrolled infectious disease within 4 weeks prior to enrollment.
• Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.
• HIV infection.
• Positive for Treponema pallidum(syphilis).
• Severe autoimmune disease or immunodeficiency, with the exception of well-controlled Type I diabetes and thyroid disorders.
• History of severe allergy or hypersensitivity to macromolecular biologic agents (e.g., antibodies, cytokines).
• Participation in any other clinical trial within 4 weeks prior to enrollment.
• History of clinically significant central nervous system (CNS) diseases, including but not limited to epilepsy, paresis, aphasia, stroke, severe head injury, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome.
• Presence of isolated CNS involvement by lymphoma, or any ongoing CNS condition that precludes accurate neurological evaluation.
• History of severe cardiovascular conditions within the past 6 months.
• Presence of psychiatric illness.
• History of drug abuse or addiction.
• Use of the following medications or therapies:

• Corticosteroids (physiologic replacement doses, and topical or inhaled steroids are permitted).
• Chemotherapy.
• GvHD Therapy.
• Allogeneic hematopoietic stem cell transplantation.
• Gene therapy.
• Women who are breastfeeding.
• In the investigator's judgment, the subject is unlikely to complete all protocol-required study visits or procedures (including follow-up visits) or unlikely to comply with the requirements for participation in this 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

Китай · 1 центр

• Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology — Ухань

Идентификаторы

NCT: NCT07260812 · KSV01-R101

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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