a Clinical Research of CD19 and CD22 Targeted Prime CAR-T Cell in Relapsed/Refractory B-ALL

Официальное название

Study Evaluating Safety and Efficacy of CD19 and CD22 Targeted Prime CAR-T Cell in Patients With Relapsed/Refractory B-ALL

Обзор

This is a single arm study to evaluate the efficacy and safety of CD19 and CD22 targeted prime CAR-T cells therapy for patients with relapsed/refractory B -ALL

Подробное описание

Although the anti-CD19 CAR-T cell therapies have gained significant results in patients with relapsed and refractory B-cell hematologic malignancies.

There are patients who resisted anti-CD19 CAR-T cells or with CD19 negative relapse. To make further improvement, the investigators launch such a clinical trial using CD19 and CD22 targeted prime CAR-T cells for patients with relapsed and refractory B-ALL to evaluate the efficacy and safety of CD19 and CD22 targeted prime CAR-T cell therapy.

Вмешательства

• Биопрепарат CD19 and CD22 targeted prime CAR-T cells
  A single infusion of CD19 and CD22 prime CAR-T cells will be administered intravenously

Первичные конечные точки

• Adverse events that related to treatment [Срок оценки: 2 years]
• The response rate of CD19 and CD22 prime CAR-T treatment in patients with relapse/refractory B-ALL [Срок оценки: 6 months]

Вторичные конечные точки (12)

• Rate of prime CAR-T cells in bone marrow [Срок оценки: 2 years]
• Rate of prime CAR-T cells in peripheral blood [Срок оценки: 2 years]
• Quantity of prime CAR copies in bone marrow [Срок оценки: 2 years]
• Quantity of prime CAR copies in peripheral blood [Срок оценки: 2 years]
• Rate of CD19 and CD22 positive cells in Bone marrow [Срок оценки: 1 years]
• Levels of IL-6 in Serum [Срок оценки: 3 months]
• Levels of IL-10 in Serum [Срок оценки: 3 months]
• Levels of TNF-α in Serum [Срок оценки: 3 months]
• Levels of CRP in Serum [Срок оценки: 3 months]
• Duration of Response (DOR) of CD19 and CD22 prime CAR-T treatment in patients with refractory/relapsed B-ALL [Срок оценки: 2 years]
• Progress-free survival(PFS) of CD19 and CD22 targeted prime CAR-T treatment in patients with refractory/relapsed B-ALL [Срок оценки: 2 years]
• Overall survival(OS) of CD19 and CD22 prime CAR-T treatment in patients with refractory/relapsed B-ALL [Срок оценки: 2 years]

Критерии участия

Критерии включения

• Signed written informed consent
• Diagnose as Relapsed and Refractory B -ALL, and meet one of the following conditions:

• Failed to standard chemotherapy regimens;
• Relapse after complete remission, high-risk and / or refractory patients ;
• Relapse after hematopoietic stem cell transplantation;
• For patients with Ph + ALL, the following conditions must be met: those who have received a standard induction chemotherapy regimen and who have not achieved complete remission after TKI treatment or have relapsed after remission (cannot tolerate TKI treatment or have contraindications to TKI treatment or the presence of TKI class) Except for drug resistant patients)
• Evidence for cell membrane CD19 or CD22 expression
• All genders ages: 2 to 75 years
• The expect time of survive is above 3 months;
• KPS>60
• No serious mental disorders ;
• Left ventricular ejection fraction ≥50%
• Sufficient hepatic function defined by ALT/AST≤3 x ULN and bilirubin≤2 x ULN;
• Sufficient renal function defined by creatinine clearance≤2 x ULN;
• Sufficient pulmonary function defined by indoor oxygen saturation≥92%;
• With single or venous blood collection standards, and no other cell collection contraindications;
• Ability and willingness to adhere to the study visit schedule and all protocol requirements.

Критерии исключения

• Previous history of other malignancy;
• Presence of uncontrolled active infection;
• Evidence of disorder that need the treatment by glucocorticoids;
• Active or chronic GVHD
• The patients treatment by inhibitor of T cell
• Pregnant or breasting-feeding women;
• Any situation that investigators regard not suitable for attending in this study (e.g. HIV , HCVinfection or intravenous drug addiction) or may affect the data analysis.

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 · 1 центр

• 920th Hospital of Joint Logistics Support Force — Куньмин

Идентификаторы

NCT: NCT04781634 · PBC025

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗