Safety and feasibility of anti-CD19 CAR T cells with fully human binding domains in patients with B-cell lymphoma.
Jennifer N Brudno, Norris Lam, Danielle Vanasse...
https://pubmed.ncbi.nlm.nih.gov/31959992Actively Recruiting
Phase 1
Age: 18Years - 65Years
All Genders
ID06138132
A Phase 1, Open-Label, Single Center Study of KYV-101, an Autologous Fully-Human Anti-CD19 Chimeric Antigen Receptor T-Cell Therapy for Non-relapsing and Progressive Multiple Sclerosis
Led by Stanford University · Updated on 2026-02-27
12
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
S
Stanford University
Lead Sponsor
K
Kyverna Therapeutics
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating KYV-101, an anti-CD19 chimeric antigen receptor (CAR) T-cell therapy, in adults with non-relapsing and progressive forms of Multiple Sclerosis (MS). MS is a neurodegenerative disease where the immune system attacks the nervous system, leading to worsening neurologic function over time. This study focuses on progressive MS patients whose disease is worsening but without recent inflammatory activity or relapses and who have not responded to existing treatments. The study involves administering KYV-101 CAR T cells following a standard lymphodepletion regimen to reduce certain immune cells before the treatment. This therapy aims to target and reduce B cells involved in MS progression. The trial is open-label and conducted at a single center, with participants receiving the investigational therapy and being closely monitored during the treatment and follow-up periods. Participants will undergo evaluations including safety assessments, laboratory tests, and clinical response measurements up to 12 months after treatment. Researchers will monitor dose-limiting toxicities, adverse events, pharmacokinetics, and pharmacodynamics of KYV-101. The study includes ongoing safety follow-up and detailed monitoring to understand the effects and response to the therapy over time.
CONDITIONS
Brief Title
A Study of Anti-CD19 Chimeric Antigen Receptor T-Cell ( CAR-T) Therapy in Subjects With Non-relapsing and Progressive Forms of Multiple Sclerosis
Who Can Participate
Age: 18Years - 65Years
All Genders
Eligibility Criteria
You may qualify if you...
- Age between 18 and 65 years at screening
- Diagnosis of Multiple Sclerosis according to 2017 McDonald Criteria
- Progressive MS as defined by 2014 Lublin criteria
- Presence of varicella-zoster virus antibodies or completed at least one dose of Shingrix vaccine at least four weeks prior to treatment
- Presence of anti Epstein-Barr virus antibodies
- Adequate organ and marrow function including specified blood counts and organ function parameters
- Negative testing for HIV, hepatitis B and C, HTLV, syphilis, herpes simplex virus, varicella-zoster, and cytomegalovirus as specified
- Females of childbearing potential must have negative pregnancy test
- Willingness to practice highly effective birth control during study and 12 months after treatment
- Ability and willingness to sign informed consent
- Adequate vital signs within specified ranges and stable blood pressure if treated for hypertension
You will not qualify if you...
- History of neuromyelitis optica spectrum disorder or MOG antibody associated disease
- Prior investigational treatment within 3 months or 5 half-lives
- Starting any disease modifying therapy between apheresis and lymphodepletion except methylprednisolone
- History of CNS or spinal cord tumor, metabolic or infectious myelopathy, other progressive neurologic disorders affecting assessments
- History of myelodysplastic syndrome or sickle cell anemia
- Coagulation abnormalities or positive antiphospholipid antibodies
- Uncontrolled infections requiring hospitalization or IV antimicrobials within 4 weeks
- Psychiatric or psychosocial conditions posing unacceptable risk
- History or presence of liver cirrhosis
- History of malignancy unless disease free for at least 3 years
- Active infections with HIV, hepatitis B or C
- CNS disorders impairing neurotoxicity evaluation
- Recent significant cardiac events or uncontrolled cardiac disease
- Receiving anticoagulation or antiplatelet therapy
- Autoimmune diseases requiring systemic immunosuppression within 2 years
- Primary immune deficiency
- Inability to comply with study visits or procedures
- History of severe hypersensitivity to study agents
- Any condition interfering with safety or efficacy assessments
- Prior total lymphoid irradiation or mitoxantrone exceeding specified dose
- Prior hematopoietic stem cell transplant, cellular immunotherapy or gene therapy
- Prior anti-CD20 monoclonal antibody treatment within 9 months or specific washout periods for other MS therapies
- History of solid organ transplantation
- Impaired cardiac function or significant cardiac disease as specified
- History of splenectomy
- Moderate or worse asthma or COPD
- Prolonged QT interval
- Valvular heart disease
- Moderate or worse renal impairment
- Prior Mavenclad treatment without sufficient washout
- History of seizure disorder
- Prior treatment with cellular immunotherapy or gene therapy for any target
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Up to 12 months
Participants receive KYV-101 anti-CD19 CAR-T cell therapy following a standard lymphodepletion regimen.
Multiple visits during treatment period as scheduled by the study team
Follow-up
Duration - Up to 12 months
Participants are monitored for safety, clinical response, and pharmacokinetics/pharmacodynamics after treatment.
Regular visits for up to 12 months post-treatment
Trial Site Locations
Total: 1 location
1
Stanford Multiple Sclerosis Center
Palo Alto, California, United States, 94304
Actively Recruiting
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Research Team
M
Multiple Sclerosis and Neuroimmunology Study Team
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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Andreas Mackensen, Fabian Müller, Dimitrios Mougiakakos...
https://pubmed.ncbi.nlm.nih.gov/36109639