A Phase I Clinical Trial Using Genetically Engineered Autologous T Cells to Express Chimeric Antigen Receptor (CAR) for Treatment of Patients With Refractory or Relapsed CD19-positive B Lymphoid Malignancies — CARTHIAE-1  

Acute Lymphoblastic Leukemia, in Relapse Clinical Trial

Official title: A Phase I Clinical Trial Using Genetically Engineered Autologous T Cells to Express Chimeric Antigen Receptor (CAR) for Treatment of Patients With Refractory or Relapsed CD19-positive B Lymphoid Malignancies

Status Not yet recruiting

Clinical Trial Summary

This is a phase l, single arm, prospective open, dose-escalation study in patients with relapsed or refractory CD19-positive B cell malignancies (ALL, NHL, CLL). The trial will include adult and pediatric patients. There will be three individual cohorts, defined by disease biology: pediatric ALL and aggressive pediatric NHL (Cohort 1), adult ALL (Cohort 2) and adult NHL/CLL (Cohort 3).

Clinical Trial Description

We will evaluate the safety of the MB-CART19.1 and determine the recommended dose levels for the Phase II clinical trial.

Dose evaluation will start in Cohorts 1 and 2 with Dose Level 1 (5x10e5 CAR T cells/Kg) and in Cohort 3 with Dose Level 2 1x10e6 CAR T cells/Kg) , sparing Dose Level 1 . Each of the cohorts will evaluate the safety of the CAR-T cells.

In each dose level of each of the three cohorts three 3 + 3 patients will be treated. A particular dose level will be expanded to 6 patients if one patient out of 3 patients treated at that particular dose level develops DLT. Once this occurs, further dose-escalations are halted until the dose has proven to be safe in the expanded cohort. If 2 or more in a cohort of 6 patients develop DLT no further dose escalation is allowed, and the next lower dose level will be expanded to 6 patients in total. The highest dose among the dose levels tested at which no more than one out of six patients experiences DLT will be considered the MTD. In Dose Level 3, three additional patients will be treated, if no DLT occurred. Dose Level 0 will be tested only if Dose Level 1 is not tolerable. ;

Related Conditions & MeSH terms

• Acute Lymphoblastic Leukemia, in Relapse
• B-cell Lymphoma Recurrent
• B-cell Lymphoma Refractory
• Chronic Lymphocytic Leukemia Recurrent
• Chronic Lymphocytic Leukemia Refractory
• Leukemia
• Leukemia, Lymphocytic, Chronic, B-Cell
• Leukemia, Lymphoid
• Lymphoma
• Lymphoma, B-Cell
• Neoplasms
• Precursor Cell Lymphoblastic Leukemia-Lymphoma
• Recurrence

• NCT number: NCT05705570
• Study type: Interventional
• Source: Hospital Israelita Albert Einstein
• Contact: Nelson Hamerschlak, MD, PhH
• Phone: +551121517248
• Email: hamer@einstein.br
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: March 1, 2023
• Completion date: December 1, 2028