Refractory or relapsed acute B-cell lymphoblastic leukemia after haematopoietic stem cell transplantation MedDRA version: 20.0 Level: SOC Classification code 10029104 Term: Neoplasms benign, malignant and unspecified (incl cysts and polyps) System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Name: CARCIK-CD19
Product Code: [PTG-CARCIK-CD19]
Pharmaceutical Form: Suspension for injection
Current Sponsor code: PTG-CARCIK-CD19
Other descriptive name: non-viral, transposon-manipulated
Sponsors
FONDAZIONE TETTAMANTI M.DE MARCHI ONLUS
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Children (1-17) and adults (18-75 years old); 2. Relapsed or refractory adult and pediatric BCP-ALL as defined for the presence of bone marrow with = 5% lymphoblasts by morphologic assessment, or if Grade I or chronic GVHD (cGVHD) greater than mild at time of enrollment and in the previous 30 days; 6. No longer taking immunosuppressive agents for at least 30 days prior to infusion; 7. No evidence of concomitant life-threatening infectious disease; 8. Life expectancy > 60 days; 9. Lansky/Karnofsky scores > 60; 10. Absence of severe renal disease (creatinine > x 3 normal for age); 11. Absence of severe hepatic disease (direct bilirubin > 3 mg/dl or SGOT > 500); 12. Patient/guardian able to give informed consent. Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 20 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 8
Exclusion criteria
Exclusion criteria: 1. GVHD Grades II-IV for patients who had previously been transplanted; 2. Any cell therapy in the last 30 days; 3. Patient with concomitant life-threatening infectious disease; 4. Lansky/Karnofsky score <60; 5. Patients with hepatic or renal disease as specific above; 6. Pregnant or breast feeding females; 7. Rapidly progressive disease that in the estimation of the investigator and sponsor would compromise ability to complete study therapy; 8. Subjects must have recovered from the acute side effects of their prior therapy, such that eligibility criteria are met; 9. HIV/HBV/HCV Infection: Seropositive for HIV antibody. Seropositive for hepatitis C or positive for Hepatitis B surface antigen (HBsAG); 10. Uncontrolled, symptomatic, intercurrent illness including but not limited to infection, congestive heart failure, unstable angina pectoris and cardiac arrhythmia; 11. Active Central Nervous System (CNS) involvement by malignancy, defined as CNS-3 per National Comprehensive Cancer Network (NCCN) guidelines. Note: Patients with history of CNS disease that has been effectively treated will be eligible
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Confirm the high overall response rate at day 28 after the first CARCIK-CD19 infusion, Improve the duration of response of patients treated with CARCIK -CD19 cells;Secondary Objective: 1.Overall Survival (OS). 2.Safety of the second administration of CARCIK-CD19. 3.Safety of autologous CARCIK-CD19 cells. 4.Safety of cordblood CARCIK-CD19 cells;Primary end point(s): ORR at 28 days after the first CARCIK-CD19 administration DOR from day 70 for patients who achieved and maintained remission after the first or the second CARCIK-CD19 administration;Timepoint(s) of evaluation of this end point: 1 month | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Overall survival (from time infusion to death) Safety of the second administration of allogeneic CARCIK-CD19 cells Safety of autologous CARCIK-CD19 cells Safety of cordblood CARCIK-CD19 cells.;Timepoint(s) of evaluation of this end point: 36 months | — |
Countries
Italy
Contacts
Public ContactUNITA' DI RICERCA CLINICA
FONDAZIONE MBBM
Outcome results
None listed