Relapsing Multiple Sclerosis (RMS)Phase 1/2NCT07006805
RESET-MS: A Study to Evaluate the Safety and Efficacy of CABA-201 in Participants With Multiple Sclerosis
A Phase 1/2 study testing CABA-201 in people with Relapsing Multiple Sclerosis (RMS) and Progressive Multiple Sclerosis (PMS), run by Cabaletta Bio.
Trial summary
RESET-MS: A Phase 1/2 Open-Label Study to Evaluate the Safety and Efficacy of Autologous CD19-specific Chimeric Antigen Receptor T cells (CABA-201) in Participants with Multiple Sclerosis Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Relapsing Multiple Sclerosis (RMS), Progressive Multiple Sclerosis (PMS), Multiple Sclerosis - Relapsing Remitting
- What is being tested?
- CABA-201
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jun 2026to Oct 2029
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- The main inclusion criteria include the following:
- Able to provide informed consent.
- Age ≥18 and ≤60 years of age.
- Diagnosis of MS per the revised 2017 McDonald criteria (Thompson et al, 2018).
- For participants with relapsing forms of MS only (RMS Cohort):
- Moderate degree of previously accumulated disability as measured by the Expanded Disability Status Scale (EDSS)
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- Documentation of clinical relapse or a positive historical gadolinium (Gd)-enhancing magnetic resonance imaging (MRI) scan prior to Screening
- Prior treatment with a high-efficacy therapy or prior treatment failure of oral therapies
- For participants with progressive forms of MS only (PMS cohort):
- Moderate Disability as measured by EDSS
- Presence of abnormal function on protocol specified EDSS Functional Systems Scale
- Objective worsening of disease prior to Screening while on standard of care therapy
- Clinical stability by vital signs assessment at the time of screening
Who cannot join
- The main exclusion criteria include the following:
- History of fulminant MS
- Clinically significant concomitant central nervous system pathologies which, in the Investigator's judgement, may confound the ability to interpret study results or complicate identification or evaluation of neurotoxicity, including but not limited to:
- Any history of seizure disorder, even if well-controlled on antiepileptics
- History of progressive multifocal leukoencephalopathy
- Active, inflammatory autoimmune disorder other than MS requiring immunomodulatory therapies
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- Positive human immunodeficiency virus (HIV), hepatitis C virus (HCV) antibody, or hepatitis B surface antigen test, or evidence of active or chronic tuberculosis (TB) at Screening or other chronic viral infections as described in the protocol
- Use of the following therapies:
- Any prior or concurrent exposure to mitoxantrone, alemtuzumab, total lymphoid irradiation
- Cladribine within 1 year of Screening
- Any investigational agent within 4 weeks or 5 half-lives of Screening, whichever is longer
- Other pre-specified Disease-Modifying Therapies be discontinued by the time of pre-conditioning or earlier as described in the protocol
- Known malignancy or a history of malignancy
- Current symptoms of severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, pulmonary, psychiatric, cardiac, or concomitant neurological disease, including severe (requiring medical intervention) and uncontrolled infections
- Chronic pulmonary disease
- Impaired cardiac function or clinically significant cardiac disease
- Prior engineered T cell therapy involving permanent gene modification
- Prior solid organ (heart, liver, kidney, lung) transplant or hematopoietic stem cell transplant.
About this study
Official title: RESET-MS: A Phase 1/2, Open-Label Study to Evaluate the Safety and Efficacy of Autologous CD19-specific Chimeric Antigen Receptor T Cells (CABA-201) in Participants With Multiple Sclerosis
RESET-MS: A Phase 1/2 Open-Label Study to Evaluate the Safety and Efficacy of Autologous CD19-specific Chimeric Antigen Receptor T cells (CABA-201) in Participants with Multiple Sclerosis
Read the detailed description
This is a Phase 1/2, open-label study designed to evaluate the safety, tolerability, and efficacy of different doses of CABA-201 in adult participants with MS to determine an appropriate dose for future studies. Any participant who receives CABA-201 will be followed after infusion for 156 weeks. Two cohorts of participants will be studied based upon their MS diagnosis.
- Relapsing MS Cohort (RMS Cohort): Participants with active relapsing MS, including relapsing remitting MS (RRMS) and relapsing secondary progressive MS (SPMS) that is treatment-resistant
- Progressive MS Cohort (PMS Cohort): Participants with worsening progressive MS, including primary progressive MS (PPMS) or non-relapsing SPMS that is treatment-resistant
The study will consist of 2 parts: Part A (dose escalation) and Part B (dose expansion).
- Conditions
- Relapsing Multiple Sclerosis (RMS), Progressive Multiple Sclerosis (PMS), Multiple Sclerosis - Relapsing Remitting, Multiple Sclerosis, Multiple Sclerosis (Relapsing Remitting), Multiple Sclerosis (MS) - Relapsing-remitting
- Being tested
- CABA-201
- Keywords
- CABA-201, Rese-cel, autoimmune disease, anti-CD19 CAR-T therapy, cellular therapy, Multiple Sclerosis, Relapsing MS, RRMS, Progressive MS, PPMS, SPMS, Neurology, Resecabtagene autoleucel
- Medical subject headings
- Multiple Sclerosis, Chronic Progressive, Multiple Sclerosis, Relapsing-Remitting, Multiple Sclerosis, Autoimmune Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CABA-201Biological
Single intravenous infusion of CABA-201 following preconditioning with fludarabine and cyclophosphamide
| Study group | Role | What they receive |
|---|---|---|
| Relapsing MS Cohort | Experimental | Not described Receives: Biological: CABA-201 |
| Progressive MS Cohort | Experimental | Not described Receives: Biological: CABA-201 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary (Part A: Dose Escalation) incidence and severity of adverse events
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal result of an investigation), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. The term AE is used to include both serious and non-serious AEs.
Measured: Up to 28 days after CABA-201 infusion
Primary (Part B: Dose Expansion) incidence of and severity of adverse events in order to confirm the dose(s) of CABA-201
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal result of an investigation), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. The term AE is used to include both serious and non-serious AEs.
Measured: Up to 28 days after CABA-201 infusion
Secondary outcomes (8)
Part A and Part B: To evaluate the incidence and severity of adverse events
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal result of an investigation), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. The term AE is used to include both serious and non-serious AEs.
Measured: Up to 156 weeks after CABA-201 infusion
Part A and Part B: To characterize the pharmacodynamics (PD)
Levels of B cells in the blood
Measured: Up to 156 weeks after CABA-201 infusion
Part A and Part B: To characterize the pharmacokinetics (PK)
Levels of CABA-201-positive T cells in the blood
Measured: Up to 156 weeks after CABA-201 infusion
Part A and Part B: To evaluate disease related biomarkers
Levels of MS biomarkers in the blood and CSF
Measured: Up to 156 weeks after CABA-201 infusion
Part A and Part B: To evaluate the effects of CABA-201 on MS disease activity as measured by Magnetic Resonance Imaging (MRI)
Incidence of accumulated MS-related lesions
Measured: Up to 156 weeks after CABA-201 infusion
Part A and Part B: The effects of CABA-201 on MS disease activity as measured by EDSS
The EDSS is a scale for assessing neurologic impairment in MS. Values are from 0 points (normal neurological examination) up to 10 points (death). Higher scores represent increased disability.
Measured: Up to 156 weeks after CABA-201 infusion
Part A and Part B: To evaluate the effect of CABA-201 on use of subsequent MS-related therapy
Proportion of participants who require no subsequent MS-related immunomodulatory therapy
Measured: Up to 156 weeks after CABA-201 infusion
Part A and Part B: To evaluate the effect of CABA-201 on patient reported and health outcomes as measured by SF-36 v2
Change in SF-36 v2
Measured: Up to 156 weeks after CABA-201 infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2025
- Study startJun 2026 (estimated)
- Primary completionSep 2028 (estimated)
- Study completionOct 2029 (estimated)
Why it stopped: The study was withdrawn prior to site activation and before enrollment of any participants due to sponsor decision to reprioritize the development portfolio.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsing Multiple Sclerosis (RMS)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cabaletta Bio
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Monitor, Study chair, Cabaletta Bio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07006805
- Sponsor's protocol ID
- CAB-201-005
- Status last verified
- Jun 2026
- First submitted
- 22 Apr 2025
- Last updated
- 25 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RESET-MS: A Phase 1/2, Open-Label Study to Evaluate the Safety and Efficacy of Autologous CD19-specific Chimeric Antigen Receptor T Cells (CABA-201) in Participants With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT07006805
- Acronym / sponsor ID
- CAB-201-005
- Conditions
- Relapsing Multiple Sclerosis (RMS), Progressive Multiple Sclerosis (PMS), Multiple Sclerosis - Relapsing Remitting, Multiple Sclerosis, Multiple Sclerosis (Relapsing Remitting), Multiple Sclerosis (MS) - Relapsing-remitting
- Keywords
- CABA-201, Rese-cel, autoimmune disease, anti-CD19 CAR-T therapy, cellular therapy, Multiple Sclerosis, Relapsing MS, RRMS
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The study was withdrawn prior to site activation and before enrollment of any participants due to sponsor decision to reprioritize the development portfolio.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Cabaletta BioIndustry (pharma, biotech, devices)
- Study start
- Jun 2026 (estimated)
- Primary completion
- Sep 2028 (estimated)
- Study completion
- Oct 2029 (estimated)
- First posted
- 5 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RESET-MS: A Phase 1/2 Open-Label Study to Evaluate the Safety and Efficacy of Autologous CD19-specific Chimeric Antigen Receptor T cells (CABA-201) in Participants with Multiple Sclerosis
Detailed description
This is a Phase 1/2, open-label study designed to evaluate the safety, tolerability, and efficacy of different doses of CABA-201 in adult participants with MS to determine an appropriate dose for future studies. Any participant who receives CABA-201 will be followed after infusion for 156 weeks. Two cohorts of participants will be studied based upon their MS diagnosis.
- Relapsing MS Cohort (RMS Cohort): Participants with active relapsing MS, including relapsing remitting MS (RRMS) and relapsing secondary progressive MS (SPMS) that is treatment-resistant
- Progressive MS Cohort (PMS Cohort): Participants with worsening progressive MS, including primary progressive MS (PPMS) or non-relapsing SPMS that is treatment-resistant
The study will consist of 2 parts: Part A (dose escalation) and Part B (dose expansion).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Relapsing MS Cohort | Experimental | Biological: CABA-201 |
| Progressive MS Cohort | Experimental | Biological: CABA-201 |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- Able to provide informed consent.
- Age ≥18 and ≤60 years of age.
- Diagnosis of MS per the revised 2017 McDonald criteria (Thompson et al, 2018).
- For participants with relapsing forms of MS only (RMS Cohort):
- For participants with progressive forms of MS only (PMS cohort):
Key exclusion criteria (18 listed)
- History of fulminant MS
- Clinically significant concomitant central nervous system pathologies which, in the Investigator's judgement, may confound the ability to interpret study results or complicate identification or evaluation of neurotoxicity, including but not limited to:
- Active, inflammatory autoimmune disorder other than MS requiring immunomodulatory therapies
- Use of the following therapies:
- Known malignancy or a history of malignancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CABA-201Single intravenous infusion of CABA-201 following preconditioning with fludarabine and cyclophosphamide | Biological | Progressive MS Cohort, Relapsing MS Cohort |
Primary outcome
Primary (Part A: Dose Escalation) incidence and severity of adverse events
Time frame: Up to 28 days after CABA-201 infusion
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal result of an investigation), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. The term AE is used to include both serious and non-serious AEs.
Primary (Part B: Dose Expansion) incidence of and severity of adverse events in order to confirm the dose(s) of CABA-201
Time frame: Up to 28 days after CABA-201 infusion
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal result of an investigation), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. The term AE is used to include both serious and non-serious AEs.
8 secondary outcomes
Part A and Part B: To evaluate the incidence and severity of adverse events
Time frame: Up to 156 weeks after CABA-201 infusion
Part A and Part B: To characterize the pharmacodynamics (PD)
Time frame: Up to 156 weeks after CABA-201 infusion
Part A and Part B: To characterize the pharmacokinetics (PK)
Time frame: Up to 156 weeks after CABA-201 infusion
Part A and Part B: To evaluate disease related biomarkers
Time frame: Up to 156 weeks after CABA-201 infusion
Part A and Part B: To evaluate the effects of CABA-201 on MS disease activity as measured by Magnetic Resonance Imaging (MRI)
Time frame: Up to 156 weeks after CABA-201 infusion
Part A and Part B: The effects of CABA-201 on MS disease activity as measured by EDSS
Time frame: Up to 156 weeks after CABA-201 infusion
Part A and Part B: To evaluate the effect of CABA-201 on use of subsequent MS-related therapy
Time frame: Up to 156 weeks after CABA-201 infusion
Part A and Part B: To evaluate the effect of CABA-201 on patient reported and health outcomes as measured by SF-36 v2
Time frame: Up to 156 weeks after CABA-201 infusion
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Monitor study chair
Cabaletta Bio
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing CABA-201 in people with Relapsing Multiple Sclerosis (RMS) and Progressive Multiple Sclerosis (PMS), run by Cabaletta Bio.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 25 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary (Part A: Dose Escalation) incidence and severity of adverse events (time frame: Up to 28 days after CABA-201 infusion). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2026; AzTrials last refreshed its copy on 27 Oct 2026.