This is an observational umbrella protocol evaluating toxicities after CAR-T therapy with ciltacabtagene autoleucel (cilta-cel) for RRMM, with a goal to identify key inflammatory features contributing to toxicities, define non-invasive biomarkers to guide clinical monitoring, and evaluate treatment strategies to reduce morbidity for patients. Toxicities of interest will include neurotoxicity, hematologic, and gastrointestinal events. Patients planned to receive cilta-cel as part of their standard of care multiple myeloma therapy will be enrolled. All patients will have baseline evaluation at the time of leukapheresis and cilta-cel infusion, as well as longitudinal blood, bone marrow, cerebrospinal fluid (CSF), and gastrointestinal (GI) samples collected for translational assessment. Patients who experience toxicities of interest as evaluated by their clinical team will undergo additional evaluation and sample collection, as guided by the involved organ system (e.g. CSF for neurologic toxicity, endoscopic evaluation with colonic biopsies for colitis), with monitoring for resolution of symptoms on therapy. Additional patients from Mount Sinai or other centers \[University of California San Francisco (UCSF), Memorial Sloan Kettering Cancer Center (MSKCC)\] who have previously been or will be treated with cilta-cel and are participating in institutional biobanks will similarly be included for ongoing sample collected per local protocols, and samples from patients experiencing toxicities of interest will be sent to Mount Sinai for analysis to supplement the prospective cohort.
Study Type
OBSERVATIONAL
Enrollment
30
UCSF Medical Center
San Francisco, California, United States
RECRUITINGMount Sinai
New York, New York, United States
RECRUITINGMemorial Sloan Kettering Cancer Center
New York, New York, United States
RECRUITINGCilta-cel peak expansion (Cmax)
Cilta-cel peak expansion (Cmax), using the maximum percentage of circulating CD3+ T cells with the cilta-cel construct measured by flow cytometry from day of infusion through day +28 post cilta-cel infusion
Time frame: 28 days post infusion
Cilta-cel peak expansion (Cmax)
Cilta-cel peak expansion (Cmax), using the maximum absolute count (cells/µL) of cells with the cilta-cel construct, measured by flow cytometry from day of infusion through day +28 post cilta-cel infusion
Time frame: 28 days post infusion
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