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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 1INTERVENTIONAL

A Study of Anti-CD19 Chimeric Antigen Receptor T-Cell ( CAR-T) Therapy in Subjects With Non-relapsing and Progressive Forms of Multiple Sclerosis

A Phase 1, Open-Label, Single Center Study of KYV-101, an Autologous Fully-Human Anti-CD19 Chimeric Antigen Receptor T-Cell (CD19 CAR T) Therapy in Subjects With Non-relapsing and Progressive Forms of Multiple Sclerosis

A Study of Anti-CD19 Chimeric Antigen Receptor T-Cell ( CAR-T) Therapy in Subjects With Non-relapsing and Progressive Forms of Multiple Sclerosis (NCT06138132) is a Phase 1 interventional studying Multiple Sclerosis and Multiple Sclerosis, Primary Progressive, sponsored by Stanford University. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

A Study of Anti-CD19 Chimeric Antigen Receptor T Cell Therapy in Subjects with Non-relapsing and Progressive Forms of Multiple Sclerosis

What Stage of Research Is This?

Phase 1 trials test a new treatment for the first time in humans, focusing on safety, dosing, and how the body processes the drug. For Multiple Sclerosis, a Phase 1 study typically enrolls a small number of participants — often healthy volunteers or patients who have exhausted standard treatment options. Phase 1 results determine whether a treatment moves into larger Phase 2 efficacy studies.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

With a target enrollment of 12 participants, this is a small study — typical of early-phase research, rare-disease trials, or pilot studies designed to generate preliminary signal before a larger study is launched.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Patient is ≥ 18 years old, and ≤65 years of age, at time of screening visit. 2. Diagnosis of MS according to the 2017 McDonald Criteria. 3. Progressive MS by 2014 Lublin MS phenotypic criteria. 4. Presence of varicella-zoster virus (VZV) antibodies, or completion of at least one dose of the varicella zoster glycoprotein E (gE) Shingrix vaccine at least four weeks prior to treatment. 5. Presence of anti EBV antibodies. 6. Organ and Marrow Function - Absolute neutrophil count (ANC) ≥ 2000/uL. - Platelet count ≥ 150,000/uL. - Absolute lymphocyte count ≥ 1000/uL. - Serum immunoglobulin G (IgG) ≥ 500mg/dL. - blood count (hemoglobin) at least 9 g/dL. - Adequate renal, hepatic, pulmonary and cardiac function defined as: - Creatinine ≤ 2mg/dL or creatinine clearance (as estimated by Cockcroft Gault Equation) ≥ 60 mL/min. - Serum alanine transaminase (ALT)/aspartate aminotransferase (AST) ≤ 3 upper limit of normal (ULN). - Total bilirubin ≤ 1.5 mg/dl, except in subjects with Gilbert's syndrome - Cardiac ejection fraction ≥ 40%, no evidence of physiologically significant pericardial effusion as determined by an ECHO, and no clinically significant ECG findings. - Baseline oxygen saturation \> 94% on room air. 7. Testing for - Hepatitis B core antibody (HBc Ab) - Hepatitis C antibody (HCV Ab) - Hepatitis B surface antigen (Hep B surf. AG) - HIV 1\&2 Ab - Syphilis Screen - Human T-cell lymphotropic virus (HTLV) Ab I \& II - Nucleic acid test multiplex (NAT MPX) for HIV, HCV, HBV - Herpes Simplex Virus 1 \& 2 IgG panel - Varicella-Zoster (VZ) IgG - Cytomegalovirus (CMV) Total Ab Must be seronegative for HIV-1 RNA polymerase chain reaction (PCR); HIV 1 and HIV 2 Ab (antibody); HTLV-1 and HTLV-2 Ab; PCR+ or negative surface antigen for hepatitis B; negative for the Treponema pallidum antibody Syphilis screen; and negative for HIV-1 and hepatitis C by nucleic acid testing (NAT) within 40 days of apheresis procedures. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: 1. Patient is ≥ 18 years old, and ≤65 years of age, at time of screening visit. 2. Diagnosis of MS according to the 2017 McDonald Criteria. 3. Progressive MS by 2014 Lublin MS phenotypic criteria. 4. Presence of varicella-zoster virus (VZV) antibodies, or completion of at least one dose of the varicella zoster glycoprotein E (gE) Shingrix vaccine at least four weeks prior to treatment. 5. Presence of anti EBV antibodies. 6. Organ and Marrow Function * Absolute neutrophil count (ANC) ≥ 2000/uL. * Platelet count ≥ 150,000/uL. * Absolute lymphocyte count ≥ 1000/uL. * Serum immunoglobulin G (IgG) ≥ 500mg/dL. * Hemoglobin ≥ 9 g/dL. * Adequate renal, hepatic, pulmonary and cardiac function defined as: * Creatinine ≤ 2mg/dL or creatinine clearance (as estimated by Cockcroft Gault Equation) ≥ 60 mL/min. * Serum alanine transaminase (ALT)/aspartate aminotransferase (AST) ≤ 3 upper limit of normal (ULN). * Total bilirubin ≤ 1.5 mg/dl, except in subjects with Gilbert's syndrome * Cardiac ejection fraction ≥ 40%, no evidence of physiologically significant pericardial effusion as determined by an ECHO, and no clinically significant ECG findings. * Baseline oxygen saturation \> 94% on room air. 7. Testing for * Hepatitis B core antibody (HBc Ab) * Hepatitis C antibody (HCV Ab) * Hepatitis B surface antigen (Hep B surf. AG) * HIV 1\&2 Ab * Syphilis Screen * Human T-cell lymphotropic virus (HTLV) Ab I \& II * Nucleic acid test multiplex (NAT MPX) for HIV, HCV, HBV * Herpes Simplex Virus 1 \& 2 IgG panel * Varicella-Zoster (VZ) IgG * Cytomegalovirus (CMV) Total Ab Must be seronegative for HIV-1 RNA polymerase chain reaction (PCR); HIV 1 and HIV 2 Ab (antibody); HTLV-1 and HTLV-2 Ab; PCR+ or negative surface antigen for hepatitis B; negative for the Treponema pallidum antibody Syphilis screen; and negative for HIV-1 and hepatitis C by nucleic acid testing (NAT) within 40 days of apheresis procedures. 8. Females of childbearing potential have a negative serum or urine pregnancy test because of the potentially dangerous/unknown effects on the fetus. Females who have undergone hysterectomy or who have been postmenopausal for at least 2 years are not considered to be of childbearing potential. 9. Contraception: Subjects of child-bearing or child-fathering potential must be willing to practice highly effective birth control from the time of enrollment on this study and for the entire study period which is 12 months after receiving the CAR T cell infusion. 10. Ability to understand and the willingness to sign a written informed consent document. Patients must have signed informed consent to participate in the trial. 11. Adequate vital sign criterion with acceptable numerical ranges of: * Systolic Blood Pressure (mmHg) ≥ 100 and ≤ 150 * Diastolic Blood pressure (mmHg) ≥ 60 and ≤ 90 * To ensure subject safety and stability, any subject who is noted to have a BP \> 150/90 mm Hg should be stable on anti-hypertensive medications with repeated BP ≤150/90 for at least one month prior to enrollment in the study * Heart Rate ≥ 60 and ≤ 100 bpm * Oral Temperature ≤ 37.7 C/afebrile * Respiratory rate ≥ 12 and ≤ 20bpm Exclusion Criteria: 1. History of neuromyelitis optica spectrum disorder (NMOSD) or MOG antibody associated disease (MOGAD). 2. Prior treatment with any investigational agent within 3 months, or 5 half-lives, whichever is longer. Agents authorized by the FDA for prevention or treatment of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) are not considered investigational. 3. Initiation of any DMT between the completion of apheresis and start of lymphodepletion (LD) chemotherapy. The use of methylprednisolone for bridging therapy between apheresis and start of LD chemotherapy will be allowed. 4. History of CNS or spinal cord tumor, metabolic or infectious cause of myelopathy, genetically inherited progressive CNS disorder, sarcoidosis or non-MS progressive neurologic condition affecting ability to perform study assessments. 5. History of cytopenia consistent with the diagnosis of myelodysplastic syndrome (MDS). 6. History of sickle cell anemia or other hemoglobinopathy. 7. Coagulation abnormalities defined by: international normalized ratio (INR) \> 1.5, prothrombin time (PT) \> 14 seconds, partial thromboplastin time (PTT) \> 45 seconds to the exclusion criteria. Patients with positive antiphospholipid antibodies, including anti-cardiolipin, or lupus anticoagulant. 8. Presence of fungal, bacterial, viral, or other infection that is not controlled and/ or requiring hospitalization or treatment with IV antimicrobials within 4 weeks of screening. Simple urinary tract infection (UTI) and uncomplicated bacterial pharyngitis are permitted if responding to active treatment. 9. Psychiatric disorder(s) or psychosocial circumstance(s) which in the opinion of the Stanford Transplant team caring for this potential patient would place the patient at an unacceptable risk. 10. Presence or history of liver cirrhosis. 11. History of malignancy other than non-melanoma skin cancer or carcinoma in situ (e.g. cervix, bladder, breast) unless disease free for at least 3 years 12. Active infection with HIV, hepatitis B (HBsAg positive) or hepatitis C virus (anti-HCV positive) as the immunosuppression contained in this study may pose unacceptable risk. A prior history of hepatitis B or hepatitis C is permitted providing the viral load is undetectable per quantitative PCR and/or nucleic acid testing. Hepatitis B surface antibody following hepatitis B immunization is not considered to be evidence of past infection. 13. Central nervous system (CNS) disorder such as cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease unrelated to MS that in the judgment of the investigator may impair the ability to evaluate neurotoxicity. 14. History of myocardial infarction, cardiac angioplasty or stenting, unstable angina, or other clinically significant cardiac disease (uncontrolled congestive heart failure) within 4 months of enrollment. Subjects with stable cardiac disease fulfilling inclusion criteria are allowed. 15. Subjects receiving anticoagulation therapy or subjects with concomitant use of antiplatelet agents. 16. History of Crohn's, rheumatoid arthritis, systemic lupus that required continued systemic immunosuppression/systemic disease modifying agents within the 2 years prior to trial enrollment. 17. A primary immune deficiency disease 18. In the investigator's judgment, the subject is unlikely to complete protocol-required study visits or procedures, including follow-up visits, or comply with the study requirements for participation. 19. History of severe immediate hypersensitivity reaction to any of the agents used in this study. This includes contraindications or life-threatening allergies, hypersensitivity, or intolerance to KYV-101 or its excipients, including dimethyl sulfoxide; Bendamustine; or tocilizumab. 20. Any medical condition that in the judgement of the investigator is likely to interfere with assessment of safety or efficacy of study treatment. 21. Prior treatment with total lymphoid irradiation or mitoxantrone exceeding 36 mg/m2 cumulative dose 22. Prior treatment with autologous hematopoietic stem cell transplantation, or prior history of cellular immunotherapy (eg. CAR T) or gene therapy directed at any target. 23. Prior treatment with anti-CD20+ monoclonal antibody therapy within 9 months of trial initiation. A 30-day washout will be required for prior treatment with glatiramer acetate, interferon-beta, and fumarates. A 60-day washout will be required for sphingosine-i-phosphate modulators and natalizumab. Excluded will be patients who received prior treatment with mitoxantrone regardless of prior cumulative dose. 24. Prior history of solid organ transplantation 25. Impaired cardiac function or clinically significant cardiac disease including: * a. Unstable angina or myocardial infarction or coronary artery bypass graft (CABG) within 6 months prior to apheresis. * b. New York Heart Association (NYHA) stage III or IV congestive heart failure. * c. History of clinically significant cardiac arrhythmia (eg, ventricular tachycardia), complete left bundle branch block, high-grade atrioventricular (AV) block. * d. History of severe nonischemic cardiomyopathy. * e. Left ventricular ejection fraction (LVEF) \<45% as assessed by echocardiogram (ECHO) or multi-gated acquisition (MUGA) scan (performed ≤8 weeks of apheresis). * f. Active, current cardiac manifestations of systemic lupus erythematosus (SLE) including pericarditis, pericardial effusion, and myocarditis. 26. Prior history of splenectomy 27. History of moderate or worse than moderate asthma or chronic obstructive pulmonary disease (COPD) 28. Corrected QT interval (QTc) \>450msec in males or \>470msecs in females 29. Subjects with valvular heart disease (regurgitation, stenosis or atresia 30. Moderate or worse renal impairment using criteria * Stage 1: Kidney damage with normal or increased GFR (\>90 mL/min/1.73 m\^2). * Stage 2: Mild reduction in GFR (60-89 mL/min/1.73 m\^2). * Stage 3a: Moderate reduction in GFR (45-59 mL/min/1.73 m\^2). * Stage 3b: Moderate reduction in GFR (30-44 mL/min/1.73 m\^2). * Stage 4: Severe reduction in GFR (15-29 mL/min/1.73 m\^2). * Stage 5: Kidney failure (GFR \< 15 mL/min/1.73 m\^2 or dialysis) 31. Previously received Mavenclad, yet drug washout is ≤9 months. 32. History of a seizure disorder even if the seizure disorder is well controlled with anti-epileptics 33. Prior history of treatment with cellular immunotherapy (e.g. CAR T) gene therapy product directed as any target.

Treatments Being Tested

BIOLOGICAL

KYV-101 anti-CD19 CAR-T cell therapy

KYV-101 anti-CD19 CAR-T cell therapy

DRUG

Standard lymphodepletion regimen

Standard lymphodepletion regimen

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Stanford Multiple Sclerosis Center
Palo Alto, California, United States

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06138132), the sponsor (Stanford University), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06138132 clinical trial studying?

A Study of Anti-CD19 Chimeric Antigen Receptor T Cell Therapy in Subjects with Non-relapsing and Progressive Forms of Multiple Sclerosis The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT06138132?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06138132?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT06138132. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06138132. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.