CD7 CAR-T Bridging to alloHSCT for R/R CD7+Malignant Hematologic Diseases

Официальное название

A Study to Evaluate the Efficacy and Safety of CD7CAR-T Bridging to Allogeneic Hematopoietic Stem Cell Transplantation in Patients With Refractory or Relapsed CD7 Positive Malignant Hematologic Diseases

Обзор

This is a single-arm, open-label, single-center, phase I/II study. The primary objective is to evaluate the safety of CD7 CAR-T Bridging to allo-HSCT therapy for patients with CD7-positive relapsed or refractory Malignant Hematologic Diseases

Вмешательства

• Препарат CD7 CAR-T cells injection
  CD7 CAR T cells treat patients with refractory or relapsed CD7 positive Malignant Hematologic Diseases
• Другое Allogeneic hematopoietic stem cell transplantation
  In this study, Allogeneic hematopoietic stem cell transplantation is used as a bridge therapy to CD7 CAR T cells infusion to treat patients with refractory or relapsed CD7 positive Malignant Hematologic Diseases

Первичные конечные точки

• Incidence and level of AE and SAE [Срок оценки: Baseline up to 28 days after CD7 CAR T-cells infusion]

Вторичные конечные точки (12)

• CAR-T cell expression [Срок оценки: Evaluate at 1, 2, 3, 4, 8,12,16, 20 and 24 weeks after CAR-T infusion]
• CAR-T related cytokine expression [Срок оценки: Evaluate at 1, 2, 3 and 4 weeks after CAR-T infusion]
• Survival Rate （SR） [Срок оценки: Evaluate at 6, 9, and 12 months]
• Time-To-Progression（TTP） [Срок оценки: Month 2,3,4,6,12,18and 24]
• Progression-free survival (PFS) [Срок оценки: Month 6,12,18and 24]
• Duration of remission,DOR [Срок оценки: Up to 1 years after Treatment]
• Overall response rate,ORR [Срок оценки: Evaluate at 4, 8, and 12 weeks after CAR-T infusion]
• Clinical Benefit Rate（CBR） [Срок оценки: Up to 24 weeks after Treatment]
• Disease Control Rate （DCR） [Срок оценки: Up to 12 weeks after Treatment]
• Overall survival, OS [Срок оценки: Up to 1 years after Treatment]
• Minimal Residual Disease [Срок оценки: Up to 2 years after Treatment]
• Bone marrow transplantation STR [Срок оценки: Evaluate at 4, 8,12,16 and 20 weeks after allogeneic hematopoietic stem cell transplantation]

Критерии участия

Критерии включения

• Provision of signed and dated informed consent form (ICF)
• Male or female, older than 18 years (including 18 years)
• Anticipated survival time more than 12 weeks
• Eastern Cooperative Oncology Group (ECOG) performance status ≤2
• According to the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines for Acute Lymphocytic Leukemia and Acute Myeloid Leukemia (2016. v1), patients diagnosed as CD7+ALL and AML
• Consistent with r/r CD7+acute leukemia diagnosis, including any of the following conditions
• a. No CR after standard chemotherapy
• b. The first induction reaches CR, but CR ≤ 12 months
• c. Patients with r/r CD7+acute leukemia have not responded to the first or multiple remedial treatments
• d. Multiple recurrences
• Philadelphia chromosome negative (Ph -) subjects; Or cannot tolerate tyrosine kinase inhibitor (TKI) treatment; Or Philadelphia chromosome positive (Ph+) subjects who did not respond to both TKI treatments
• Normal lung function, oxygen saturation greater than 92% without oxygen inhalation
• The blood biochemical test results are consistent with the following results
• a. (AST) and (ALT) ≤ 2.5 × (ULN)
• b. Total bilirubin ≤ 1.5 × ULN
• c. 24-hour serum creatinine clearance ≥ 30 mL/min
• d. Lipase and amylase ≤ 2 × ULN
• Fertility capable men and women of childbearing age must agree to use effective contraception starting with the signing of an informed consent form until within 2 years after the use of the study drug. Women of reproductive age include pre menopausal women and women within 2 years after menopause. The blood pregnancy test for women of reproductive age must be negative at screening

Критерии исключения

• Patients with the history of epilepsy or other CNS disease
• Pregnant or breastfeeding
• Active infection with no cure
• Patients with prolonged QT interval time or severe heart disease
• Have experienced hypersensitivity or intolerance to any drug used in this study
• Patients who received anticancer chemotherapy or other drug treatment within 2 weeks before screening
• Previous malignant tumors that require treatment or have evidence of recurrence within the previous 5 years of screening
• Clinically significant central nervous system lesions such as seizures, cerebral vascular ischemia/hemorrhage, dementia, cerebellar disease, psychosis, active central nervous system involvement, or cancerous meningitis
• In the past 2 years, terminal organ damage caused by autoimmune diseases (such as Crohn's disease, rheumatoid arthritis, systemic lupus erythematosus) or the need for systematic application of immunosuppressive or other systemic disease control drugs
• Severe active viral, bacterial, or uncontrolled systemic fungal infections; Genetic bleeding/coagulation disorders, a history of non-traumatic bleeding or thromboembolism, and other diseases that may increase the risk of bleeding
• Patients who received autologous hematopoietic stem cell transplantation (ASCT) within 8 weeks before screening, or who plan to undergo ASCT during this study
• Participated in clinical trials of other drugs within 4 weeks or 5 drug half-lives (T1/2) before screening
• Any situation that the researchers believe may increase the risk of patients or interfere with the test results.

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

• The first affiliated hospital of medical college of zhejiang university — Ханчжоу

Идентификаторы

NCT: NCT05827835 · TXB2022023

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗