Clinical trial NCT05252403: Residual Disease Driven Strategy for CARCIK (CD19) in Adults/Pediatric BCP-ALL
Official title: Measurable Residual Disease Driven Strategy for One or Two Infusions of Non- Viral, Transposon-manipulated CARCIK (CD19) Cells: A Phase II Study in Pediatric and Adult Patients With Relapsed/Refractory B Cell Precursor ALL (BCP-ALL)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Acute Lymphoblastic Leukemia
Keywords: ALL
Lead sponsor: Fondazione Matilde Tettamanti Menotti De Marchi Onlus
Sponsor class: OTHER
First posted: 2022-02-23
Enrollment: 35
Sex: ALL
Minimum age (years): 1
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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;

Primary outcomes:
measure: To evaluate the overall response rate: change from baseline at day 28 after the first CARCIK-CD19 infusion
timeFrame: Baseline and day 28
measure: To evaluate the overall response rate: change from baseline at day 28 after the first CARCIK-CD19 infusion
timeFrame: Baseline and day 28
measure: To evaluate the overall response rate: change from baseline at day 28 after the first CARCIK-CD19 infusion
timeFrame: Baseline and day 28
measure: 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
timeFrame: Day 28 and month 2, 3, 4, 5, 6, 9 and 12
measure: 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
timeFrame: Day 28 and month 2, 3, 4, 5, 6, 9 and 12
measure: 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
timeFrame: Day 28 and month 2, 3, 4, 5, 6, 9 and 12
Secondary outcomes:
Other outcomes:
Locations:
city: Bergamo
country: Italy
facility: Ospedale PG23
city: Monza
country: Italy
facility: Fondazione MBBM
Study officials:
References: