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NOT YET RECRUITING
NCT07665307

Delayed Toxicities Post-CAR-T

Sponsor: Icahn School of Medicine at Mount Sinai

View on ClinicalTrials.gov

Summary

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.

Official title: An Umbrella Observational Study to Determine Novel Actionable Biomarkers, Mechanisms, and Mitigation of Rare Chimeric Antigen Receptor T Cell (CAR-T) Toxicities in Relapsed/Refractory Multiple Myeloma (RRMM)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

30

Start Date

2026-06

Completion Date

2029-06-18

Last Updated

2026-06-24

Healthy Volunteers

No

Locations (3)

UCSF Medical Center

San Francisco, California, United States

Mount Sinai

New York, New York, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States