Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06451159 | A Study of KYV-101, a CD19 CAR T Cell Therapy, in Participants With Treatment Refractory Progressive Multiple Sclerosis | PHASE1 | ACTIVE NOT_RECRUITING | 10 | — | — | Jun 20, 2024 | Feb 1, 2027 | Jan 23, 2026 | 1 | United States |
To surmise CNS penetration of CAR-T cells.
* Disease reactivation as defined by the presence of new T2 hyperintense or GAD enhancing lesions on MRI brain at 8 weeks post-infusion of KYV-101. * Incidence of detectable anti-KYV-101 antibodies in peripheral blood. * Incidence of detectable T cells specific to KYV-101 drug product in peripheral blood. * Detectable replication competent lentivirus as measured by surrogate assay (VSV-G qPCR). * Persistence of IgG antibody titers to common vaccine related antigens (varicella, measles, mumps, rubella, tetanus). * Change from baseline in depression/anxiety including C-SSRS.
| Arm | Type | Description |
|---|---|---|
| Dosing Cohort #1: KYV-101 CAR+ T -- 0.33 ×10^8 cells | EXPERIMENTAL | Five participants will be enrolled at the lower dose (0.33 ×10\^8 cells). Once safety and tolerability are adequately assessed, treatment will proceed to the higher dose level. |
| Dosing Cohort #2: KYV-101 CAR+ T -- 1×10^8 cells | EXPERIMENTAL | An additional five participants are planned for enrollment at the higher dose level (1×10\^8 cells). |
| Name | Type | Description |
|---|---|---|
| KYV-101 (Biological) - 0.33 ×10^8 cells | BIOLOGICAL | KYV-101 is a type of treatment called CAR T-cell therapy. It uses cells from your own immune system, called T-cells, to attack cells that cause inflammation. T-cells are a type of white blood cell. |
| KYV-101 (Biological) - 1 ×10^8 cells | BIOLOGICAL | KYV-101 is a type of treatment called CAR T-cell therapy. It uses cells from your own immune system, called T-cells, to attack cells that cause inflammation. T-cells are a type of white blood cell. |
| Chemotherapy: cyclophosphamide (CYC) | DRUG | Participants will receive one 3-day cycle of lymphodepletion with CYC 300 mg/m2 prior to administration of KYV-101. |
| Chemotherapy: fludarabine (FLU) | DRUG | Participants will receive one 3-day cycle of lymphodepletion with FLU 30 mg/m2 prior to administration of KYV-101. |
Inclusion Criteria: 1. Participant must sign a written informed consent form (ICF) prior to any screening procedures. 2. Participant must be 25-70 years of age (inclusive). 3. Clinical diagnosis of MS with evidence of primary or secondary progressive MS based on 2017 International Panel Criteria (T...