Идёт набор NCT07284433

Study of Allo-QuadCAR01-T, an Allogeneic CAR-T Targeting CD19/CD20, in Patients With Relapsed or Refractory B-Cell Malignancies

Фаза I / Фаза II С лечением Lymphoma Diffuse Large B-cell Leukemia and Lymphoma Leukemia Relapse Lymphoma Receiving CAR-T Therapy

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Cyclophosphamide (Non-IMP, Lymphodepletion), Fludarabine (Non-IMP, Lymphodepletion), Allo-QuadCAR01-T.
Кому может быть актуально: Состояния в реестре: Lymphoma Diffuse Large B-cell, Leukemia and Lymphoma, Leukemia Relapse, Lymphoma Receiving CAR-T Therapy. Базовые параметры: от 18 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: США, Германия
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

A Single-arm, Multicenter, Open-label, Phase I/II Trial of Allo-QuadCAR01-T, an Allogeneic CAR-T-cell Therapy Targeting CD19 and CD20, for the Treatment of Relapsed or Refractory B-cell Malignancies

Обзор

This study is testing Allo-QuadCAR01-T, a new off-the-shelf CAR-T therapy for people with hard-to-treat B-cell cancers. Unlike current CAR-T treatments that use a patient's own cells, this therapy uses donor cells that are ready to use, which can save time and reduce costs. It targets two proteins, CD19 and CD20, to lower the chance of relapse and uses gene editing to make it safer. The trial has three parts: first to find a safe dose, then to confirm it, and finally to test how well it works in patients with diffuse large B-cell lymphoma (DLBCL). Patients will get one infusion after chemotherapy to prepare their body. The main goal is to check safety and see how many patients have a complete response by Week 13. About 160 patients will take part, and researchers will follow them for up to 15 years.

Вмешательства

Другое Cyclophosphamide (Non-IMP, Lymphodepletion)
Intravenous infusion over 3 days (d-5 to d-3)
Другое Fludarabine (Non-IMP, Lymphodepletion)
Intravenous infusion over 3 days (d-5 to d-3)
Препарат Allo-QuadCAR01-T
Single dose IV infusion on Day 1

Первичные конечные точки

Incidence of AEs defined as DLTs [Срок оценки: At the end of cycle 1 (in total 28 days, given no treatment interruptions)]
To determine the maximum tolerated dose (MTD) [Срок оценки: At the End of Cycle 1 (in total 28 days, given no treatment interruptions)]
To determine the incidence of dose-limiting toxicities (DLT) [Срок оценки: At the end of cycle 1 (in total 28 days, given no treatment interruptions)]
Phase 2: Complete response rate (CRR) [Срок оценки: Up to week 13]

Вторичные конечные точки (9)

Pharmacokinetics of Allo-QuadCAR01-T in PB in patients after infusion of Allo-QuadCAR01-T [Срок оценки: Up to 24 months]
To investigate the impact of Allo-QuadCAR01-T on MRD [Срок оценки: Up to 24 months]
To evaluate immunogenicity against Allo-QuadCAR01-T [Срок оценки: Up to 24 months]
To evaluate host immune cell depletion and reconstitution resulting from LD [Срок оценки: Up to 24 months]
Overall Response Rate (ORR) [Срок оценки: Up to 24 months]
Progression-Free Survival (PFS) [Срок оценки: Up to 24 months]
Duration of Response (DOR) [Срок оценки: Up to 24 months]
Overall Survival (OS) [Срок оценки: Up to 24 months]
Time to Next Treatment (TTNT) [Срок оценки: Up to 24 months]

Критерии участия

Критерии включения

Adults 18 years or older.
Diagnosed with relapsed or refractory B-cell non-Hodgkin lymphoma (B-NHL) or chronic lymphocytic leukemia (CLL).
Must have received at least 2 prior lines of therapy.
ECOG performance status 0-1 (able to carry out daily activities).
Adequate organ function (heart, liver, kidneys).
HLA B/C match with donor cells.
No active uncontrolled infections.

Критерии исключения

Active CNS involvement (including PCNSL) in dose escalation cohorts; may be allowed in later cohorts with Sponsor approval.
Prior CAR-T within 3 months of screening, or ≥Grade 3 ICAHT from prior CAR-T.
Autologous stem cell transplant within 3 months.
Prior allogeneic stem cell transplant or solid organ transplant.
Prior therapy with dual CD19/CD20 CAR-T.
Severe hypersensitivity to trial agents or similar compounds.
History of GvHD or post-transplant lymphoproliferative disorder.
Presence of La/SS-B autoantibodies or related autoimmune diseases.
Other malignancy that may interfere with trial, except:

Curatively treated basal/squamous skin cancer or cervical carcinoma in situ
Low-grade, early-stage prostate cancer (Gleason ≤6, Stage 1-2) with no therapy needed
Adjuvant endocrine therapy for non-metastatic breast cancer (≥2 years)
Any other curatively treated malignancy in remission ≥2 years
Active viral infection within 1 week of screening, or serious bacterial/fungal infection.
Hemorrhagic cystitis.
Active neuro-autoimmune disease (e.g., MS, Guillain-Barré, ALS).
Active or residual HBV, HCV, or syphilis.
Active HIV. History of HIV may be eligible with Sponsor approval if:
Neurological disorders within 6 months (e.g., stroke, dementia, Parkinson's, cerebellar disease, CNS autoimmune disease).
Significant cardiac disease within 6 months (e.g., MI, stent, unstable angina).
Primary immunodeficiency or autoimmune disease requiring systemic treatment within 1 year (unless stable and Sponsor-approved).
Unresolved ≥Grade 2 non-hematologic toxicity from prior therapy (except neuropathy up to Grade 2).
Systemic immunosuppression within 28 days.
Last systemic lymphoma/CLL therapy (standard or investigational) within 28 days or 5 half-lives.
Major surgery within 14 days.
Local radiation within 28 days.
Live vaccination within 28 days.
Pregnant or breastfeeding.