Residual Disease Driven Strategy for CARCIK (CD19) in Adults/Pediatric BCP-ALL

Fondazione Matilde Tettamanti Menotti De Marchi Onlus35 enrolled

Overview

This is a single arm, open-label, multi-center, phase II study to determine the activity and the safety of a therapeutic strategy that allows a second CARCIK-CD19 cells infusion, driven by the status of disease from one month after the first infusion, in adult and pediatric patients with r/r BCP- ALL.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Acute Lymphoblastic Leukemia

Interventions

PTG-CARCIK-CD19GENETIC

PTG-CARCIK-CD19 cells is a gene therapy medicinal product (GTMP) composed of genetically modified allogeneic T lymphocytes formulated as cell suspension in normal saline solution and freezing media

Eligibility

Sex: ALLMin age: 1 YearMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: Children (1-17) and adults (18-75 years old); * Relapsed or refractory adult and pediatric B- ALL as defined for the presence of bone marrow with ≥ 5% lymphoblasts by morphologic assessment, or if \<5%, with at least 1% of molecular disease at PCR; * Evidence of CD19 tumor expression in bone marrow and/or peripheral blood by flow cytometry; * Diagnosis of CD19 positive ALL in the bone marrow, and/or peripheral blood and/or extramedullary sites with the exclusion of Central Nervous System (CNS) if CNS-3 disease. Exclusion Criteria: * GVHD Grades II-IV for patients who had previously been transplanted; 2. Any cell therapy in the previous 30 days; * Patient with concomitant life-threatening infectious disease; * Lansky/Karnofsky score \<60; * Patients with hepatic or renal disease as specific above; * Pregnant or breast-feeding females; * Rapidly progressive disease that in the estimation of the investigator and sponsor would compromise ability to complete study therapy;

Locations (2)

Ospedale PG23

Bergamo, Italy

RECRUITING

Fondazione MBBM

Monza, Italy

RECRUITING

Outcomes

Primary Outcomes

To evaluate the overall response rate: change from baseline at day 28 after the first CARCIK-CD19 infusion

At baseline and at Day 28 after infusion: lymphoblasts \< 5% at morphological evaluation of bone marrow aspirate

Time frame: Baseline and day 28

To evaluate the overall response rate: change from baseline at day 28 after the first CARCIK-CD19 infusion

At baseline and at Day 28 after infusion: lymphoblasts \< 5% at flow cytometry bone marrow evaluation

Time frame: Baseline and day 28

To evaluate the overall response rate: change from baseline at day 28 after the first CARCIK-CD19 infusion

At baseline and at Day 28 after infusion: molecular evaluation of disease positivity \<0.01%

Time frame: Baseline and day 28

To evaluate the duration of response of patients treated with CARCIK - CD19 cells. Change from day 28 at month 2, 3, 4, 5, 6, 9 and 12

Day 28 and month 2, 3, 4, 5, 6, 9 and 12: lymphoblasts \< 5% at morphological evaluation of bone marrow aspirate

Time frame: Day 28 and month 2, 3, 4, 5, 6, 9 and 12

To evaluate the duration of response of patients treated with CARCIK - CD19 cells. Change from day 28 at month 2, 3, 4, 5, 6, 9 and 12

Day 28 and month 2, 3, 4, 5, 6, 9 and 12: lymphoblasts \< 5% at flow cytometry bone marrow evaluation

Time frame: Day 28 and month 2, 3, 4, 5, 6, 9 and 12

To evaluate the duration of response of patients treated with CARCIK - CD19 cells. Change from day 28 at month 2, 3, 4, 5, 6, 9 and 12

Day 28 and month 2, 3, 4, 5, 6, 9 and 12: molecular evaluation of disease positivity \<0.01%

Time frame: Day 28 and month 2, 3, 4, 5, 6, 9 and 12

Data from ClinicalTrials.gov

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