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Precursor Cell Lymphoblastic Leukemia-Lymphoma

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Cyclophosphamide

Fludarabine

Fludarabine phosphate

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Alkylating Agents

Lymphodepleting regimen, consisting of Cyclophosphamide 60mg/kg IV on day -6 and Fludarabine 25mg/m2 IV on days -5 to -3. Followed by infusion of Chimeric antigen receptor T-cells (CAR-T) on day 0

Fludarabine 25mg/m\^2 IV on days -5 to -3

Level -1 (1 x 105 cells/kg)

Level 1 \[Starting dose\] (5 x 105 cells/kg)

Level 2 (1 x 106 cells/kg)

Level 3 (2 x 106 cells/kg)

Chimeric antigen receptor T cells to be implemented in a "3 + 3" design on day 0

Nelson Hamerschlak, MD, PhH

Lucila Kerbauy, MD, PhD

Jose Mauro Kutner, MD, PhD

Lucila Kerbauy, MD, PhH

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).

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.

A phase I study, with a "3+3" dose escalation design

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

The RP2D will be the maximum tolerated dose (MTD) or the highest dose studied if an MTD is not obtained.

Overall survival (OS) and progression-free survival (PFS) will be assessed by dose cohort and in the first two groups at the MTD (or at the highest dose studied).

Blood samples for determination of persistence/phenotyping of infused CAR-T cells will be analysed.

Miltenyi Biotec, Inc.

Hospital Israelita Albert Einstein

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
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	NCT05705570	Acute Lymphobla... Acute Lymphobla... B-cell Lymphoma... B-cell Lymphoma... Chronic Lymphoc... Chronic Lymphoc...	Cyclophosphamid... Fludarabine Chimeric antige...	2 Years - 70 Years	Hospital Israelita Albert Einstein
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	NCT05705570	Acute Lymphobla... Acute Lymphobla... B-cell Lymphoma... B-cell Lymphoma... Chronic Lymphoc... Chronic Lymphoc...	Cyclophosphamid... Fludarabine Chimeric antige...	2 Years - 70 Years	Hospital Israelita Albert Einstein

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