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Observational Study on Delayed Toxicities After CAR-T Therapy for Multiple Myeloma

This is an observational study looking at side effects (toxicities) that can happen after a specific CAR-T cell therapy called ciltacabtagene autoleucel (cilta-cel) for people with multiple myeloma that has come back or not responded to previous treatments (relapsed/refractory multiple myeloma, RRMM). The study aims to understand what causes these side effects, find ways to detect them early without invasive procedures, and improve treatments to reduce patient discomfort. Researchers will collect blood, bone marrow, spinal fluid (cerebrospinal fluid, CSF), and gut (gastrointestinal, GI) samples from about 30 participants. You may be eligible if you are 18 or older and are planning to receive cilta-cel as part of your standard care. The main goal is to measure how much cilta-cel expands in your body (Cmax) 28 days after infusion.

Study design
This is an observational study involving about 30 participants. It is not testing a new treatment but rather observing patients receiving standard care.
What's involved
You will have evaluations at the time of cell collection (leukapheresis) and cilta-cel infusion. Longitudinal blood, bone marrow, cerebrospinal fluid (CSF), and gastrointestinal (GI) samples will be collected.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint, cilta-cel peak expansion, is measured 28 days post infusion.

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NCT07665307

Delayed Toxicities Post-CAR-T

Not Yet Recruiting
Not specifiedAges 18+Observational
Icahn School of Medicine at Mount Sinai
~30 participants
Updated 2026-06-24 on ClinicalTrials.gov

At a glance

Recruiting sites
0 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Cilta-cel peak expansion (Cmax)
Measured over 28 days post infusion
+1 more outcome measured

Conditions

Multiple Myeloma

Explore related trials

Multiple Myeloma

Where it's being run

3 sites across 2 states
New York2
California1

Study leadership

  • Samir Parekh · PRINCIPAL_INVESTIGATOR · Professor , MD/PHD, Mount Sinai

Who to contact

Vikram Madan
[email protected]
347.835.3446
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Subject is ≥18 years of age at the time of signing the informed consent form (ICF).
Subject must understand and voluntarily sign an ICF prior to any study-related assessments/procedures being conducted.
Subject is willing and able to adhere to the study visit schedule and other protocol requirements.
All subjects must have documented diagnosis of MM and be eligible for commercial CAR-T therapy with cilta-cel. Patients planned for standard of care cilta-cel whose cell product is considered out of specification after manufacture will still be eligible to proceed with the current study protocol if proceeding with cilta-cel infusion
All patients must have ECOG Performance Status ≤ 2.

Exclusion

Subjects with monoclonal gammopathy of undetermined significance (MGUS), smoldering multiple myeloma (SMM), primary amyloidosis (no active multiple myeloma), Waldenström's macroglobulinemia, or POEMS syndrome (plasma cell dyscrasia with polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes)
Subjects with active plasma cell leukemia (defined as either 5% of peripheral blood white blood cell count comprised of plasma/CD138+ cells or an absolute plasma cell count of 2 x 109/L)
Subjects with active Central Nervous System (CNS) involvement with multiple myeloma
Cardiac conditions including:
New York Heart Associated class 3 or 4 congestive heart failure
Myocardial infarction or coronary artery bypass graft (CABG) ≤6 months prior to enrollment
History of clinically significant ventricular arrhythmia
History of severe non-ischemic cardiomyopathy
Stroke or seizure within 6 months of enrollment
Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the patient from signing the informed consent form
Any serious concurrent medical conditions that may make the patient non-evaluable or put the patient's safety at risk, per the discretion of the treating physician or PI
Patients with a positive PCR test for hepatitis B virus or hepatitis C virus indicating active infection. Patients with positive serologic testing indicating exposure will need confirmatory testing by PCR.
Patients who are seropositive for HIV
Prior or concurrent malignancy, except for the following:
Adequately treated basal cell or squamous cell skin cancer or in-situ carcinoma.
Non-muscle invasive bladder cancer treated within the last 24 months that is considered completely cured.
Localized prostate cancer (N0M0):
with a Gleason score of ≤6, treated within the last 24 months or untreated and under surveillance,
with a Gleason score of 3+4 that has been treated more than 6 months prior to full study screening and considered to have a very low risk of recurrence; or
any history of localized prostate cancer and receiving androgen deprivation therapy and considered to have a very low risk of recurrence per the discretion of the treating physician or PI
Non-invasive cervical cancer treated within the last 24 months that is considered completely cured.
Breast cancer: adequately treated lobular carcinoma in situ, or ductal carcinoma in situ, or history of localized breast cancer and receiving anti-hormonal agents and considered to have a very low risk of recurrence.
Any other cancer from which the subject has been disease free for \> 3 years prior to study entry, or considered cured with minimal risk of disease recurrence.
Prior treatment with CAR-T
Prior allogeneic stem cell transplant
Major cardiac surgery within 8 weeks prior to cilta-cel; all other major surgery within 4 weeks prior to cilta-cel.
Patients who are pregnant or breastfeeding
Subjects with following physical and laboratory test findings:
Absolute neutrophil count \< 1 x 109/L without growth factor support within 1 week, or absolute neutrophil count \< 0.5 x 109/L for patients with documented Duffy-null blood typing
Platelets \< 50 x 109/L without transfusion support within 1 week
Creatinine clearance \< 30 ml/min according to the Cockroft-Gault formula:
Female CrCl = \[(140 - age in years) x weight in kg x 0.85\] / \[72 x serum creatinine in mg/dl\]
Male CrCl = \[(140 - age in years) x weight in kg x 1.00\] / \[72 x serum creatinine in mg/dl\]
Total bilirubin ≥ 2 x ULN (≥ 3 x ULN if documented Gilbert's syndrome)
AST or ALT ≥ 3x ULN
Corrected serum calcium \> 13.5 mg/dL
Are also excluded:
Prisoners or subjects who are involuntarily incarcerated
Subjects who are compulsorily detained for treatment of either a psychiatric or physical (e.g., infectious disease) illness

What this trial measures

  • Cilta-cel peak expansion (Cmax)28 days post infusion

    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

  • Cilta-cel peak expansion (Cmax)28 days post infusion

    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