Status and phase
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About
This open-label, single arm Phase I trial aims to determine the safety and tolerability of anti-CD19 chimeric antigen receptor-expressing (CAR) T cells (UCD19 CAR T) in adults B-ALL that are in first complete remission with minimal residual disease (MRD) positivity. This trial will enroll 10 patients for apheresis and treatment with lymphodepleting chemotherapy followed by UCD19 CAR T cell infusion. Patients will be assessed for dose limiting toxicities (DLTs) (within 42 days after CAR T infusion), duration of B cell aplasia, overall response rate (at 1-, 3-, 6- and 12-months), and overall survival and event free survival (at 12- and 24- months) post UCD19 CAR T infusion.
Enrollment
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Inclusion criteria
Age: ≥ 18 years of age with no upper age limit
ECOG Performance Status ≤ 2
Confirmed B-cell ALL in first complete morphologic remission
MRD positivity as defined by:
Peripheral blood CD3 count must be > 0.15 x 106 cells/mL within 14 days prior to proceeding with apheresis.
Toxicities from prior therapy must be stable and recovered to ≤ grade 2 (except for clinically non-significant toxicities such as alopecia).
Adequate organ function as defined by:
i. Baseline oxygen saturation > 92% on room air and; ii. Pulmonary Function Test: Diffuse capacity of the lungs for carbon monoxide (DLCO), forced expiratory volume in one second (FEV1) and forced vital capacity (FVC) are all ≥50% of predicted by spirometry after correcting for hemoglobin.
Females of childbearing potential must have a negative serum pregnancy test (females who have undergone surgical sterilization or who have been postmenopausal for at least 2 years are not considered to be of childbearing potential).
Subjects of childbearing or child-fathering potential must be willing to practice birth control from the time of enrollment on this study and for 12 months after receiving the UCD19 infusion; females of childbearing potential must have a negative pregnancy test.
Must be able to give informed consent; subjects unable to give informed consent will not be eligible for this study.
Be able to consent to long-term follow-up protocol
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
14 participants in 1 patient group
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Central trial contact
Andrew Roth, PhD; Derek Schatz
Data sourced from clinicaltrials.gov
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