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Tests treatment safety and results for Relapsing Multiple Sclerosis
Official title An Open-label Study to Assess the Safety, Efficacy, and Cellular Kinetics of YTB323 in Relapsing Multiple Sclerosis
ClinicalTrials.gov ID: NCT06617793
What this study is testing
What is rapcabtagene autoleucel (YTB323)?
rapcabtagene autoleucel (YTB323) is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for relapsing multiple sclerosis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is an open-label, multi-center, non-confirmatory study to assess the safety, efficacy, and cellular kinetics of YTB323 in approximately 28 participants with Relapsing Multiple Sclerosis (RMS) with breakthrough disease activity during previous treatment with a highly efficacious therapy (BD-HET). The study design utilizes an ascending single dose design consisting of 3 sentinel cohorts followed by an expansion cohort.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 60
You may be able to join if
- Signed informed consent, and able to communicate well with the investigator and comply with the requirements of the study
- Adequate renal, hepatic, cardiac, hematological, and pulmonary function
- Male or female participants, ≥18 years to ≤60 years at screening, with diagnosis of RMS according to the 2017 McDonald diagnostic criteria Evidence...
- Confirmed Clinical MS relapse
- Persistent radiological activity defined by one of the following:
You likely can't join if
- Diagnosis of primary progressive multiple sclerosis (PPMS) according to the 2017 revision of the McDonald diagnostic criteria at screening
- History of or current clinically significant CNS disease (e.g. stroke, traumatic brain or spinal injury, history or presence of myelopathy) or...
- Evidence of clinically significant cardiovascular (such as but not limited to myocardial infarction, unstable ischemic heart disease, New York Heart...
- Have donated blood or experienced a loss of blood \> 400 mL within 3 months prior screening, or longer if required by local regulations
- Any prior stem cell therapy or organ transplantation or gene therapy
- Any contraindications to LP, including but not limited to:
See the full eligibility criteria
- Signed informed consent, and able to communicate well with the investigator and comply with the requirements of the study
- Adequate renal, hepatic, cardiac, hematological, and pulmonary function
- Male or female participants, ≥18 years to ≤60 years at screening, with diagnosis of RMS according to the 2017 McDonald diagnostic criteria Evidence of recent (i.e. within 1 year) breakthrough disease activity while at...
- Confirmed Clinical MS relapse
- Persistent radiological activity defined by one of the following:
- ≥2 T1 gadolinium-enhancing lesions on a single MRI scan
- ≥1 T1 gadolinium-enhancing lesions on two or more separate MRI scans
- ≥2 new T2 lesions compared to a previous scan within a period ≤1 year
- Ambulatory patients (EDSS of 3 to 6 points, inclusive assessed outside of relapse)
- Disease duration less than 15 years
- Participants must receive or be current on all recommended vaccinations according to institutional, local, or global guidelines for immunocompromised patients at least 6-weeks prior to lymphodepletion
- Diagnosis of primary progressive multiple sclerosis (PPMS) according to the 2017 revision of the McDonald diagnostic criteria at screening
- History of or current clinically significant CNS disease (e.g. stroke, traumatic brain or spinal injury, history or presence of myelopathy) or neurological disorders which may mimic MS or ICANS at screening
- Evidence of clinically significant cardiovascular (such as but not limited to myocardial infarction, unstable ischemic heart disease, New York Heart Association (NYHA) Class III/IV left ventricular failure, arrhythmia...
- Have donated blood or experienced a loss of blood \> 400 mL within 3 months prior screening, or longer if required by local regulations
- Any prior stem cell therapy or organ transplantation or gene therapy
- Any contraindications to LP, including but not limited to:
- Known or suspected structural abnormality of the lumbar spine that, in the opinion of the Investigator, may interfere with the performance of the LP, or increase the risk of the procedure for the participant
- Presence of risk for increased or uncontrolled bleeding including, but not limited to, vascular abnormalities or neoplasms at or near the LP site, disorders of the coagulation cascade, platelet function, or platelet...
- Participants on anticoagulants (e.g., warfarin) or antiplatelets [except for low-dose aspirin (100 mg/day or lower) and low-dose ibuprofen (600 mg/day or lower) which are allowable], are not eligible to participate
- Participants not willing or able to take MRI scans as per protocol. Unable to undergo MRI due to for example claustrophobia, or presents absolute contraindications to MRI (e.g., metallic implants, metallic foreign...
The study team makes the final eligibility decision.
Where it's taking place
- Darlinghurst, New South Wales, Australia
- Melbourne, Victoria, Australia
- Montpellier, France
- Nancy, France
- Rennes, France
- Bochum, Germany
- Essen, Germany
- Mainz, Germany
- Ulm, Germany
- Genova, GE, Italy
- Milan, MI, Italy
- Barcelona, Spain
- Córdoba, Spain
- Madrid, Spain
- Valencia, Spain
- Bern, Switzerland
- Lausanne, Switzerland
- Zurich, Switzerland
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 60 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Darlinghurst, New South Wales, Australia; Melbourne, Victoria, Australia; Montpellier, France; Nancy, France; Rennes, France; Bochum, Germany and 12 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.