This is a multicenter, first-in-human, Phase 1/2 study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and anti-tumor activity of DR-01 in adult patients with large granular lymphocytic leukemia or cytotoxic lymphomas
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
69
DR-01 is a non-fucosylated, human immunoglobulin G1 (IgG1) monoclonal antibody.
Dren Investigational Site
Birmingham, Alabama, United States
RECRUITINGDren Investigational Site
Duarte, California, United States
RECRUITINGDren Investigational Site
Redwood City, California, United States
RECRUITINGDren Investigational Site
New Haven, Connecticut, United States
Part A: Safety and Tolerability. To determine the incidence and severity of adverse events as assessed by CTCAE v5.0.
Time frame: Up to 25 months
Part A: Safety and Tolerability. To determine the incidence and severity of dose limiting toxicities (DLTs) as defined by protocol specified DLT criteria.
Time frame: During First 28 days (Cycle 1)
Part A: To determine potential pharmacologically optimized dose/regimen for DR-01 in LGL leukemia and cytotoxic lymphoma populations as determined using an integrated assessment of efficacy, safety, PK/PD, and exposure-response relationships.
Time frame: Up to 6 months
Part B: Overall Response Rate (ORR), defined as the proportion of subjects with Complete Response (CR) or Partial Response (PR) based on disease-specific response criteria.
Time frame: Up to 24 months
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Dren Investigational Site
Tampa, Florida, United States
RECRUITINGDren Investigational Site
Boston, Massachusetts, United States
NOT_YET_RECRUITINGDren Investigational Site 1
New York, New York, United States
RECRUITINGDren Investigational Site 2
New York, New York, United States
NOT_YET_RECRUITINGDren Investigational Site
Columbus, Ohio, United States
RECRUITINGDren Investigational Site 2
Pittsburgh, Pennsylvania, United States
RECRUITING...and 26 more locations