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

NCT05252403 | Unknown Phase 2

• 1 other identifier: FT03CARCIK
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Acute Lymphoblastic Leukemia

Keywords

ALL

Outcome Measures

Primary Outcomes (6)

• 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

  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

  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%

  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

  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

  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%

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

Study Arms (1)

CARCIK-CD19

EXPERIMENTAL

Genetic: PTG-CARCIK-CD19

Interventions

PTG-CARCIK-CD19 GENETIC

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

CARCIK-CD19

Eligibility Criteria

• Age: 1 Year - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• Fondazione Matilde Tettamanti Menotti De Marchi Onlus: lead

Study Sites (2)

Ospedale PG23

Bergamo, Italy

RECRUITING

Fondazione MBBM

Monza, Italy

RECRUITING

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2022
• First Posted: February 23, 2022
• Study Start: December 1, 2021
• Primary Completion: December 1, 2024
• Study Completion: March 1, 2025
• Last Updated: May 6, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

IT (2)