This study has two parts with distinct study objectives and study design. In part A, odronextamab is studied as an intravenous (IV) administration with a dose escalation and a dose expansion phase for B-NHL and CLL. The dose escalation phase for B-NHL and the CLL study are closed at the time of protocol amendment 17. In part B, odronextamab is studied as a subcutaneous (SC) administration with a dose finding and a dose expansion phase for B-NHL.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
200
Administered by intravenous (IV) infusion
Administered by subcutaneous (SC) injection
University of California, Irvine
Orange, California, United States
Safety/overall frequency of adverse events (AEs)
Part A and B
Time frame: Up to 24 months
Safety/dose limiting toxicities (DLTs)
Part A and B
Time frame: Up to 28 days
Antitumor activity as measured by the objective response rate (ORR)
Expansion Cohorts: • Diffuse large B-cell lymphoma (DLBCL) after failure of CAR-T therapy Part A
Time frame: Through study completion, an average of 24 months
Pharmacokinetics (Concentration of odronextamab)
Peak plasma concentration (Cmax) of odronextamab Part A and B
Time frame: Up to 10 months
Incidence of anti-drug antibodies (ADA) to odronextamab
Part A and B
Time frame: Over time; up to approximately 15 months
Titer of ADA to odronextamab
Part A and B
Time frame: Over time; up to approximately 15 months
Incidence of neutralizing antibodies (NAb) to odronextamab over time
Part A and B
Time frame: Over time; Up to approximately 15 months
Objective response rate (ORR)
For dose escalation portion and expansion cohorts: * Aggressive lymphoma expansion cohort 2 * FL grade 1-3a expansion cohorts 1 and 2 (Part A) For dose escalation and dose expansion cohorts: * FL grade 1-3a * DLBCL * DLBCL post CAR T failure (Part B)
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Stanford University
Stanford, California, United States
H. Lee Moffitt Cancer Center
Tampa, Florida, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Dana Farber Cancer Institute (Massachusetts General Hospital and Beth Israel)
Boston, Massachusetts, United States
Mayo Clinic
Rochester, Minnesota, United States
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Weill Cornell Medical College
New York, New York, United States
...and 12 more locations
Time frame: Through study completion, an average of 24 months
Progression-free survival
Part A and B
Time frame: Up to 48 months
Overall Survival
Part A and B
Time frame: Until death or lost to follow-up/ withdrawal, approximately up to 48 months
Duration of response (DOR)
Part A and B
Time frame: Until progression, approximately up to 48 months
Minimal residual disease (MRD) for patients with CLL
Part A
Time frame: Up to 24 months
Duration of Complete Response (DOCR)
Part B
Time frame: Until progression, approximately up to 48 months