Hematological disorders (ALL
Conditions
Interventions
Product Name: AP1903
Pharmaceutical Form: Solution for infusion
CAS Number: 195514-63-7
Current Sponsor code: AP1903
Other descriptive name: AP1903
Concentration unit: mg/kg milligram(s)/kilogram
Conc
Sponsors
Bellicum Pharmaceuticals, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Signed written informed consent by the patient or the patient’s guardian for children who are minors 2. enrolled on BP-004 protocol, received BPX-501 infusion and completed 6 months of active treatment Are the trial subjects under 18? yes Number of subjects for this age range: 170 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 5 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Lack of parents’/guardian’s informed consent for children who are minors.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the long-term safety of the infusion of BPX-501 gene modified T cells and to evaluate disease-free survival at 1 and 2 years;Secondary Objective: Long-term safety for a total of 15 years from BPX-501 administration;Primary end point(s): Incidence of disease-free survival in both malignant and non-malignant patients at 1 and 2 years.;Timepoint(s) of evaluation of this end point: Up to 2 years post-transplant | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Long-term safety for a total of 15 years from BPX-501 administration;Timepoint(s) of evaluation of this end point: 15 years | — |
Countries
Italy
Contacts
Public ContactMartha French
Bellicum Pharmaceuticals, Inc
Outcome results
None listed