Delayed Toxicities Post-CAR-T

Part of paid clinical trials in San Francisco, California.

Sponsor
Icahn School of Medicine at Mount Sinai
Study ID
NCT07665307
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Study Details

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.

Key Dates

Start date
Jun 30, 2026
Status verified
Jun 2026
Primary completion
Jun 18, 2029
Completion
Jun 18, 2029

Study Design

Enrollment
30 participants (estimated)

Arms

  • Arm: Observational
    Patients who are planned to go for CAR-T to treat their multiple myeloma

Primary Outcome Measure

Cilta-cel peak expansion (Cmax) [ Time Frame: 28 days post infusion ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
UCSF Medical CenterSan FranciscoCalifornia94143
Anupama Kumar
[email protected]
Ajai Chari (PRINCIPAL_INVESTIGATOR)
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065
Maximilian Merz
[email protected]
Maximilian Merz (PRINCIPAL_INVESTIGATOR)
Mount SinaiNew YorkNew York10029
Vikram Madan, MPH
[email protected]
Nicole Devito
[email protected]
samir parekh (PRINCIPAL_INVESTIGATOR)

Find similar trials in San Francisco, CA

By condition
Multiple myeloma
By specialty
OncologyBlood cancer
By research site
UCSF Medical Center· San Francisco, CAMemorial Sloan Kettering Cancer Center· New York, NYMount Sinai· New York, NY

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