CD30 CAR-T in the Treatment of CD30 Positive Relapsed/Refractory Lymphoma

Официальное название

Clinical Study on the Safety and Efficacy of Chimeric Antigen Receptor Gene Modified T Cells Targeting CD30 in the Treatment of CD30 Positive Relapsed/Refractory Lymphoma

Обзор

The is a prospective, open-label, dose-climbing clinical study assessing the efficacy and safety of CD30 CAR-T in the treatment of r/r CD30+ lymphoma. Plan to recruit 15 subjects with r/r CD30+ lymphoma。

Подробное описание

The goal of this clinical trial is to explore the effect of CD30 CAR-T on CD30 positive relapsed/refractory lymphoma. The main questions it aims to answer are:

To evaluate the safety of autologous CD30 CAR-T therapy in CD30-positive relapsed/refractory lymphoma; To evaluate the efficacy of autologous CD30 CAR-T therapy for CD30-positive relapsed/refractory lymphoma; To evaluate the metabolism of CD30 CAR-T cells in vivo; Preliminary evaluation of the correlation between CAR T cell dose and clinical efficacy.

Вмешательства

• Препарат chimeric antigen receptor gene modified T cells
  The rate of intravenous infusion of CD30 CAR T cells was 10 mL to 20 mL/min, and the infusion was performed using a blood transfusion apparatus with a filter screen. Use saline rinsing tube prior to infusion; Rinse the infusion bag with 10 mL\~30 mL normal saline.

Первичные конечные точки

• Overall response rate [Срок оценки: 6 months]
• To evaluate safety and dose limiting toxicities (DLT) of autologous CD30 CAR-T and establish the recommended Phase dose [Срок оценки: 28 days]

Вторичные конечные точки (2)

• Disease-free survival [Срок оценки: 3years]
• Overall Survival [Срок оценки: 3 years]

Критерии участия

Критерии включения

• Age≥15 years and ≤80years，female and male；
• CD30+ lymphocyte malignancies;
• CD30 expression >10% by immunohistochemistry；
• At least 1 measurable lesion can be measured according to theLugano 2014 evaluation criteria;
• Not suitable for autologous hematopoietic stem cell transplantation or recurrence after autologous hematopoietic stem cell transplantation;
• Not suitable for BV treatment or relapse after BV treatment, and the expression of CD30 was confirmed by histology;
• The estimated survival time ≥3 months;
• ECOG performance status 0-2，KPS>60%;
• Sufficient organ function：ALT，AST≤2.5×ULN，patients with liver invasion can be relaxed to ≤ 5 x ULN；serum total bilirubin<34 μmol/L；creatinine clearance rate>30 mL/min；EF≥40%；No pericardial effusion and obvious arrhythmia；SpO2≥92%；
• ALC ≥0.5×109/L，PLT>30×109/L，Hb>80 g/L and subjects had apheresis venous access and no contraindications for blood cell separation;
• MRI showed no central involvement of lymphoma;
• Patients with fertility must be willing to be able to use reliable contraceptive measures ;
• The subject or legal guardian can understand and voluntarily sign the written informed consent.

Критерии исключения

• Lymphoma-associated hemophagic cell syndrome;
• Pregnant or lactating women, and women who have a pregnancy plan within six months;
• Hepatitis B（HBsAg、HBsAb、HBeAg、HBeAb、HBcAb），Hepatitis C（Anti-HCV），Anti-HIV Ⅰ/Ⅱ and anti-TP positive（Hepatitis B DNA test is negative except）;
• Suffered from other malignant tumors, except for for skin basal cell carcinoma, skin squamous cell carcinoma and cervical carcinoma in situ undergoing the radical treatment;
• Received Anti-CD30 Ab therapy within 4 weeks before enrollment;
• Unresolved > Grade 1 non-hematologic toxicity associated with any prior treatments;
• Active uncontrolled bleeding or a known bleeding diathesis;
• Autologous hematopoietic stem cell transplantation was performed within 6 weeks;
• Uncontrollable active bacterial or fungal infection；
• Known allergy to the study drug and its components;
• Suffer from active autoimmune diseases that require systemic treatment ;
• Persons with mental or mental illness who cannot cooperate with treatment and efficacy evaluation;
• Participated in other clinical studies within 1 months prior to this study;
• History of allogeneic hematopoietic stem cell transplantation;
• patients with any condition which the investigator or treating physician feels would interfere with the trial or the safety of the subject.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Последовательный дизайн

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Shanxi Bethune Hospital — Taiyuan

Идентификаторы

NCT: NCT06850285 · ICT-CD30-2311-1

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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