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NCT07665307 · ClinicalTrials.gov registry record
Delayed Toxicities Post-CAR-T
A clinical trial, sponsored by Icahn School of Medicine at Mount Sinai.
- Not yet
- Registry status
- 30
- Enrollment target
NCT07665307: Clinical Trial study, sponsored by Icahn School of Medicine at Mount Sinai.
NCT07665307 is a clinical trial that has not yet begun recruiting, run by Icahn School of Medicine at Mount Sinai. The registered enrollment target is 30 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07665307 has not yet begun recruiting, sponsored by Icahn School of Medicine at Mount Sinai.
- NOT YET RECRUITING
- Registry status
- 30 participants
- Enrollment target
Study 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.
Primary Outcome
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
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2026-06 |
| Est. Completion | 2029-06-18 |
What is known before NCT07665307 opens enrollment
NCT07665307 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 30 participants, a relatively small participant target.
The record links to 0 conditions, and to 0 interventions.
NCT07665307 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07665307 about?
NCT07665307 is a clinical study titled "Delayed Toxicities Post-CAR-T". 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 ...
What is the current status of trial NCT07665307?
This trial is currently not yet recruiting. The enrollment target is 30 participants. The study started on 2026-06. Estimated completion is 2029-06-18.
Who is sponsoring clinical trial NCT07665307?
This trial is sponsored by Icahn School of Medicine at Mount Sinai, which has 708 total clinical trials registered on ClinicalTrials.gov.
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