Идёт набор NCT06777979

CD19-CD22-Bispecific Chimeric Antigen Receptor (CAR) T Cell Therapy for Pediatric Patients With Acute Lymphoblastic Leukemia

Фаза I С лечением Acute Lymphoblastic Leukemia Recurrent Acute Lymphoblastic Leukemia Recurrent B Acute Lymphoblastic Leukemia

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: Fludarabine, Cyclophosphamide, Mesna, CD19-CD22 CAR T cell infusion.
Кому может быть актуально: Состояния в реестре: Acute Lymphoblastic Leukemia, Recurrent Acute Lymphoblastic Leukemia, Recurrent B Acute Lymphoblastic Leukemia. Базовые параметры: до 21 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
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Официальное название

CD19-CD22-Bispecific Chimeric Antigen Receptor (CAR) T Cell Therapy for Pediatric Patients With Acute Lymphoblastic Leukemia (1922CAR)

Обзор

This study is a phase I study designed to evaluate the safety of CD19-CD22-CAR T cells. Primary Objective: To determine the safety profile and propose the recommended phase 2 dose (RP2D) of autologous CD19-CD22-CAR T cells in patients ≤ 21 years of age with recurrent/refractory CD19- and/or CD22-positive leukemia. Secondary Objective: To evaluate the anti-leukemic activity of CD19-CD22-CAR T cells.

Подробное описание

Treatment will include a single course of lymphodepleting chemotherapy (fludarabine/cyclophosphamide) followed by CAR T cell infusion. CAR T cell dose will be determined by the protocol-defined dose escalation scheme, based on the number of CAR+ T cells and participant weight.

Вмешательства

Препарат Fludarabine
IV
Препарат Cyclophosphamide
IV
Препарат Mesna
IV
Устройство CD19-CD22 CAR T cell infusion
CAR T cell infusion will be given intravenously, either centrally or peripherally.

Первичные конечные точки

Recommended phase 2 dose (RP2D) of CD19-CD22-CAR T cells [Срок оценки: up to 4 weeks after CD19-CD22-CAR T-cell infusion]
Incidence of adverse events [Срок оценки: up to 4 weeks after CD19-CD22-CAR T-cell infusion]

Критерии участия

Collection and Manufacturing Eligibility

Критерии включения

Age <21 years old
Relapsed/refractory CD19- and/or CD22-positive acute leukemia defined as:

\*CD19 and/or CD22-positivity confirmed within 2 months and after receipt of any CD19 or CD22-directed therapy

Second or greater relapse
Any relapse after allogeneic HCT
Refractory disease (primary or in relapse) despite therapy designed to induce remission
Estimated life expectancy of > 12 weeks
Karnofsky or Lansky (age-dependent) performance score ≥50 (Appendix A)
For females of childbearing age:

Not lactating with intent to breastfeed
Not pregnant with negative serum or urine pregnancy test within 7 days prior to enrollment

Критерии исключения

Known primary immunodeficiency
Known HIV positivity
Known contraindication to receiving protocol defined lymphodepleting
chemotherapy regimen
History of hypersensitivity reaction to murine protein-containing products

Treatment Eligibility

Критерии включения

Age < 21 years old
Detectable disease in the bone marrow
Estimated life expectancy of > 8 weeks
Karnofsky or Lansky (age-dependent) performance score > 50 (Appendix A)
Adequate cardiac function defined as left ventricular ejection fraction >40%, or shortening fraction > 25%
EKG without evidence of clinically significant arrhythmia
Adequate renal function defined as creatinine clearance or radioisotope GFR >50 mL/min/1.73m2 (GFR >40 mL/min/1.73m2 if <2 years of age)
Adequate pulmonary function defined as forced vital capacity (FVC) >50% of predicted value; or pulse oximetry >92% on room air
Total bilirubin < 3 times the upper limit of normal for age, except in subjects with Gilbert's syndrome
Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) < 5 times the upper limit of normal for age
Has recovered from all NCI CTAE grade III-IV, non-hematologic acute toxicities from prior therapy
Prior to planned CAR T cell infusion, patients with a history of prior allogeneicHCT must be at least 3 months from HCT, have no evidence of acute GVHD, and have not received a donor lymphocyte infusion (DLI) within the 28 daysprior to planned infusion
For females of childbearing age:

Not lactating with intent to breastfeed
Not pregnant with negative serum or urine pregnancy test within 7 days prior to enrollment
If sexually active, agreement to use birth control until 3 months after T cell infusion. Male partners should use a condom.