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This study is a multi-center study to evaluate the safety of KUR-502 in subjects with refractory/relapsed B-cell NHL or leukemia (ALL or CLL).
Full description
KUR-502 will be manufactured from leukapheresis products from healthy donors. Subjects will be enrolled into 2 parallel cohorts (Cohort A [non-ALL] and Cohort B [ALL]). Each cohort will undergo dose escalation independently.
Three (3) dose levels will be evaluated in the ANCHOR and ANCHOR2 studies combined (1×107/m2, 3×107/m2, 1×108/m2). Dose levels are defined based on the number of transduced KUR-502 cells. Body surface area (BSA) will be capped at 2.4 m2. Subjects will receive <1×104 allogeneic T cells/kg at any dose level.
The MTD will be determined once dose escalation is completed, and all subjects are evaluable for DLT. If there is no DLT that determines an MTD, a maximum dose level will be declared. Dose escalation will stop when 6 subjects have been treated at the MTD or highest dose level.
Enrollment
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Inclusion and exclusion criteria
INCLUSION CRITERIA
Subjects must meet all of the following criteria to be included in this study:
Signed written informed consent.
Diagnosis of CD19+ B-cell lymphoma or leukemia (ALL or CLL).
The disease is:
Cohort A (non-ALL subjects):
Cohort B (ALL subjects):
Measurable disease by current criteria (Lugano criteria for lymphomas, IWG criteria for CLL, and detectable disease for ALL).
Age 3 to 75 years; subjects <18 years old will not be enrolled as the first subject on any dose level.
BSA ≤2.4 m2.
Bilirubin <2 times the upper limit of normal (ULN) (3 times if the subject has Gilbert syndrome).
Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <5 times ULN.
Estimated glomerular filtration rate (GFR) ≥50 mL/min.
Pulse oximetry ≥90% on room air.
Karnofsky or Lansky score ≥70.
Recovered from the acute toxic effects of all prior chemotherapy based on the enrolling physician's assessment (if some effects of chemotherapy are expected to last long term, for example, residual neuropathy, anemia, or alopecia, subject is eligible if meets other eligibility criteria).
Life expectancy >12 weeks.
Exclusion Criteria:
Subjects who meet any of the following criteria will be excluded from this study:
Females who are breastfeeding or pregnant at Screening (as documented by a positive urine or serum pregnancy test; may be performed by local laboratory).
Females of childbearing potential who:
Males who have not had a successful vasectomy (confirmed azoospermia) or they and their female partners do not meet the criteria above (ie, not of childbearing potential or practicing highly effective contraception through the Day 365 visit or for 30 days after study drug discontinuation). No sperm donation is allowed through the Day 365 visit or for 30 days after study drug discontinuation.
Currently receiving any investigational agents or received any cellular therapies within the previous 6 weeks prior to the KUR-502 infusion.
History of Grade 2 to 4 GvHD.
History of hypersensitivity reactions to murine protein-containing products.
Active infection with human immunodeficiency virus (HIV) or human T cell lymphotropic virus (HTLV).
Active infection with hepatitis B virus (HBV) or hepatitis C virus (HCV).
Uncontrolled active bacterial, fungal, or other viral infection.
Primary purpose
Allocation
Interventional model
Masking
36 participants in 2 patient groups
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Central trial contact
Dan Lang, MD, PhD
Data sourced from clinicaltrials.gov
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