This study is being done to determine the safety, efficacy and tolerability of a single 50 mCi dose of 131I-Apamistamab given prior to FDA approved (commercially available) infusion in patients with Relapsed or refractory (R/R) non-Hodgkin lymphoma.
This is an open-label single-cohort multi-institutional study of 131I-Apamistamab followed by CAR-T cell therapy for patients with (R/R) DLBCL. Patients will receive a 50 mCi single planned 131I-Apamistamab dose prior to CAR-T cell infusion for lymphodepleting conditioning. There will be a 6-patient safety run-in to assess safety.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
single 50 mCi dose of 131I-Apamistamab given prior to CAR-T cell infusion.
CAR-T cell therapy
University of Texas Southwestern Medical Center
Dallas, Texas, United States
RECRUITINGDose-limiting toxicity (safety) -Part A (safety run-in)
The number and percentage of patients with DLTs will be summarized for Part A using the DLT Analysis Set. The data analysis set will include all patients in Part A who received study medication and either experienced a DLT or completed at least 75% of the DLT period. Toxicity will be assessed according to the NCI Common Toxicity Criteria for Adverse Events (CTCAE), version 5.0.
Time frame: Start of treatment up to 30 days post CAR T-cell infusion
Complete response (efficacy) -Part B (Cohort expansion)
Measurement of effect (response and progression) will be conducted using a PET/CT scan which will report the Lugano criteria for response at screening 1 and 2 (if PET available), Day 30 +7 days, and Day 100 +/-7 days
Time frame: Screening visit to Day 100 visit
Severity of cytokine release syndrome (CRS)
Incidence and severity of CRS (all grades, as well as grade ≥3 CRS) following 131I-Apamistamab and CAR-T cell infusion in patients with R/R DLBCL will be collected. The number and percent of subjects developing versus not developing grade ≥3 neurologic toxicity following 131I-Apamistamab and CAR-T cell infusions will be summarized using the EAS. Efficacy Analysis Set (EAS): is defined as all patients in the SAS who have at least one post-baseline response assessment or discontinued the study due to disease progression (including death caused by disease progression).
Time frame: within 100 days of CAR T-cell infusion
Severity of immune effector cell-associated neurotoxicity (ICANS)
Neurologic toxicities (ICANS) will be graded by The American Society for Blood and Marrow Transplantation (ASBMT) Consensus Grading criteria for ICANS. The number and percent of subjects developing versus not developing grade ≥3 neurologic toxicity following 131I-Apamistamab and CAR-T cell infusions will be summarized using the EAS. Efficacy Analysis Set (EAS): is defined as all patients in the SAS who have at least one post-baseline response assessment or discontinued the study due to disease progression (including death caused by disease progression).
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Time frame: within 100 days of CAR T-cell infusion