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

Phase 2

Recruiting

• Conditions: Acute Lymphoblastic Leukemia
• Interventions: Genetic: PTG-CARCIK-CD19

• Registration Number: NCT05252403
• Lead Sponsor: Fondazione Matilde Tettamanti Menotti De Marchi Onlus

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-12-01
• Study First Submitted: 2022-01-24
• Study First Submitted QC: 2022-02-12
• Study First Posted: 2022-02-23
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-03
• Last Update Posted: 2023-05-06
• Primary Completion: 2024-12
• Study Completion: 2025-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 35

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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CARCIK-CD19	PTG-CARCIK-CD19	-

Primary Outcome Measures

Name	Time	Method
To evaluate the overall response rate: change from baseline at day 28 after the first CARCIK-CD19 infusion	Baseline and day 28	At baseline and at Day 28 after infusion: molecular evaluation of disease positivity \<0.01%
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	Day 28 and month 2, 3, 4, 5, 6, 9 and 12: molecular evaluation of disease positivity \<0.01%

Trial Locations

Locations (2)

Fondazione MBBM; 🇮🇹 Monza, Italy

Ospedale PG23; 🇮🇹 Bergamo, Italy