Targeting CD19/CD20 Dual-targeted Cell in Patients With Relapsed/Refractory B-cell Non-Hodgkin Lymphoma

Официальное название

A Phase I, Open-label Clinical Study to Evaluate the Safety, Tolerability, and Efficacy of LUCAR-G39D, a Dual-targeted Cell Preparation Targeting CD19/CD20, in Patients With Relapsed/Refractory B-cell Non-Hodgkin Lymphoma

Обзор

A phase I, open-label clinical study to evaluate the safety, tolerability, and efficacy of LUCAR-G39D, a dual-targeted cell preparation targeting CD19/CD20, in patients with relapsed/refractory B-cell non-Hodgkin lymphoma.

Подробное описание

This is an open-label, dose-escalation/dose extension study to assess the safety, tolerability, and efficacy of LUCAR-G39D in the patient ≥ 18 years of age with relapsed or refractory B-cell non-Hodgkin lymphoma. Subjects who meet the eligibility criteria will receive a single dose of LUCAR-G39D injection. The study will include the following sequential phases: screening, pre-treatment (lymphodepleting chemotherapy), treatment, and follow-up.

Вмешательства

• Биопрепарат LUCAR-G39D cells product
  Prior to infusion of the LUCAR-G39D, subjects will receive a conditioning premedication regimen consisting of cyclophosphamide and fludarabine.

Первичные конечные точки

• Incidence, severity and type of TEAEs (Treatment-emergent Adverse Events) [Срок оценки: Through study completion , an average of 2 years after LUCAR-G39D infusion (Day 1)]
• Pharmacokinetics in peripheral blood [Срок оценки: Through study completion , an average of 2 years after LUCAR-G39D infusion (Day 1).]
• Pharmacokinetics in bone marrow [Срок оценки: Through study completion , an average of 2 years after LUCAR-G39D infusion (Day 1)]
• The recommended Phase II dose (RP2D) for this cell therapy [Срок оценки: Within 30 days after LUCAR-G39D infusion]

Вторичные конечные точки (6)

• Overall Response Rate (ORR) [Срок оценки: Through study completion, an average of 2 years after LUCAR-G39D infusion (Day 1)]
• Progression-free survival (PFS) [Срок оценки: Through study completion, an average of 2 years after LUCAR-G39D infusion (Day 1)]
• Overall Survival (OS) [Срок оценки: Through study completion, an average of 2 years after LUCAR-G39D infusion (Day 1)]
• Time to Response (TTR) [Срок оценки: Through study completion, an average of 2 years after LUCAR-G39D infusion (Day 1)]
• Duration of Response (DoR) [Срок оценки: Through study completion, an average of 2 years after LUCAR-G39D infusion (Day 1)]
• Immunogenicity assessment of LUCAR-G39D cells [Срок оценки: Through study completion, an average of 2 years after LUCAR-G39D infusion (Day 1)]

Критерии участия

Критерии включения

• Subjects have fully understood the possible risks and benefits of participating in this study, are willing to follow and able to complete all trial procedures, and have signed informed consent.
• Aged 18-75 years (inclusive).
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Histologically confirmed B-cell non-Hodgkin Lymphoma that expresses at least one of CD19/CD20.
• At least one evaluable tumor lesion according to Lugano 2014 criteria.

Response to prior therapy is consistent with one of the following:

• Primary refractory.
• Relapsed or refractory after 2 or more lines of therapy.
• For LBCL, 3B FL. t-iNHL:

• Relapse within 12 months after first-line chemoimmunotherapy to achieve CR;
• Progression or relapse within 12 months after autologous hematopoietic stem cell transplantation;

7\. Life expectancy≥ 3 months 8. Clinical laboratory values meet screening visit criteria

Критерии исключения

Subject eligible for this study must not meet any of the following criteria:

1\. Prior antitumor therapy with insufficient washout period ; 2. Patients who received autologous CAR-T cell therapy (except CD19-targeted) or autologous gene therapy; 3. Patients who received allogeneic hematopoietic stem cell transplantation or allogeneic therapy; 5. Patients who are positive for any index of hepatitis B surface antigen (HBsAg), hepatitis B virus deoxyribonucleic acid (HBV DNA), hepatitis C antibody (HCV-Ab), hepatitis C virus ribonucleic acid (HCV RNA), or human immunodeficiency virus antibody (HIV- Ab).

6\. Known life-threatening allergies, hypersensitivity, or intolerance to LUCAR-G39D CAR-T cell or its excipients, including DMSO.

7\. Pregnant or lactating women;

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 · 2 центра

• Oncology Department, The First Affiliated Hospital of USTC west district — Хэфэй
• Tianjin Cancer Hospital — Тяньцзинь

Идентификаторы

NCT: NCT06395870 · LB2303-0001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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