Anti CD19 Gene Therapy for B-cell Lymphoma

Официальное название

Early Exploratory Clinical Study of CD19-targeted Gene Injection (LCAR02) in Patients With Relapsed/Refractory B-cell Lymphoma

Обзор

This is an open label, single-site, dose-escalation study in up to 18 participants with treatment of relapsed/refractory B-cell lymphoma. This study aims to evaluate the safety and efficacy of the treatment with an Anti- CD19 gene injection

Вмешательства

• Препарат Anti-CD19 gene injection
  Intravenous infusion of Anti-CD19 gene injection （three dosage groups）

Первичные конечные точки

• Adverse events [Срок оценки: up to 1 years]
• The persistence, accumulation, and migration of anti-CD19 gene injection [Срок оценки: up to 1 years]

Вторичные конечные точки (3)

• Complete response (CR) rate [Срок оценки: up to 1 year]
• Objective response rate (ORR) [Срок оценки: up to 1 year]
• Duration of Response (DOR) [Срок оценки: up to 1 year]

Критерии участия

Критерии включения

• (1)Age 18 years or older, any gender; (2)Patients diagnosed with any of the following conditions: diffuse large B-cell lymphoma (DLBCL), germinal center or activated B-cell type; primary cutaneous DLBCL; primary mediastinal (thymic) large B-cell lymphoma; ALK-positive anaplastic large B-cell lymphoma; high-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements; high-grade B-cell lymphoma; T-cell-rich B-cell lymphoma; transformed follicular lymphoma; or any aggressive B-cell lymphoma arising from indolent lymphoma; follicular lymphoma; mantle cell lymphoma; large cell transformation of CLL. Patients must have previously received at least second-line standard treatment and either did not achieve remission or relapsed after remission; (3) For B-cell lymphoma patients, according to the preliminary assessment, staging, and response evaluation recommendations for Hodgkin and non-Hodgkin lymphomas (2014 edition), there must be at least one measurable lesion at baseline, which is defined as a lymph node lesion with a long diameter >15 mm or an extranodal lesion with a long diameter >10 mm, diagnosed by PET-CT or CT imaging; (4) B-cell lymphoma patients must have tumor cells confirmed CD19 positive by immunohistochemistry; (5) Adequate vital organ function: liver function meeting: ALT ≤3×ULN, AST ≤3×ULN; serum creatinine ≤140 μmol/L; total bilirubin ≤2×ULN, or ≤3×ULN in patients with Gilbert's syndrome; hemodynamically stable as determined by echocardiography or multi-gated radionuclide angiography (MUGA) with left ventricular ejection fraction (LVEF) ≥45%; no active pulmonary infection, and percutaneous arterial oxygen saturation ≥92% without supplemental oxygen; (6) ECOG performance status: 0-2; (7) Expected survival of more than 3 months; (8) Female and male participants of childbearing potential must agree to use reliable and effective contraception from the time of signing the informed consent form until 2 years after receiving LCAR02 infusion (excluding natural family planning methods).

Критерии исключения

• (1) Patients who have experienced central nervous system diseases or pathological changes within 6 months before screening, including but not limited to: stroke, cerebrovascular accident, aneurysm, epilepsy, convulsions, aphasia, severe traumatic brain injury, dementia, Parkinson's disease, cerebellar diseases, organic brain syndrome, or mental disorders.

(2) Patients with malignant tumors other than B-cell lymphoma. (3) Patients who received vaccines or B-cell targeted therapy within 4 weeks before screening.

(4) Patients with systemic autoimmune diseases or immunodeficiency. (5) Patients with grade 2-4 acute graft-versus-host disease (GVHD) or moderate to severe chronic GVHD within 4 weeks before screening.

(6) Patients with relatively severe heart disease, such as angina, myocardial infarction, heart failure, or arrhythmia.

(7) Patients with a history of severe allergies to the drugs or excipients used in the clinical study or investigational drugs.

(8) Patients with active hepatitis B, HCV antibody positivity, HIV antibody positivity, or positive for syphilis.

(9) Patients with active infections requiring intravenous antibiotics or hospitalization.

(10) Pregnant or breastfeeding women.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Последовательный дизайн

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Anhui Provincial Hospital — Хэфэй

Идентификаторы

NCT: NCT07211048 · 2025ky481

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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