Clinical trial
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)
Name
FT03CARCIK
Description
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.
Trial arms
Trial start
2021-12-01
Estimated PCD
2024-12-01
Trial end
2025-03-01
Status
Recruiting
Phase
Early phase I
Treatment
PTG-CARCIK-CD19
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
Arms:
CARCIK-CD19
Size
35
Primary endpoint
To evaluate the overall response rate: change from baseline at day 28 after the first CARCIK-CD19 infusion
Baseline and day 28
To evaluate the overall response rate: change from baseline at day 28 after the first CARCIK-CD19 infusion
Baseline and day 28
To evaluate the overall response rate: change from baseline at day 28 after the first CARCIK-CD19 infusion
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
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
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
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;
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 35, 'type': 'ESTIMATED'}}
Updated at
2023-05-06
1 organization
1 product
1 indication
Product
PTG-CARCIK-CD19Indication
Acute Lymphoblastic Leukemia