Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Poseida Therapeutics, Inc., a member of the Roche Group | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
This study aims to explore the safety, tolerability, cellular kinetics, and pharmacodynamics of P-CD19CD20-ALLO1 in participants with progressive multiple sclerosis (PMS) and relapsing multiple sclerosis (RMS).
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose Escalation | Experimental | Participants will receive a lymphodepleting chemotherapy regimen followed by a single infusion of P-CD19CD20-ALLO1. Dose escalation decisions will be made after participants are observed for a minimum of 28 days for toxicity. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| P-CD19CD20-ALLO1 Cells | Biological | P-CD19CD20-ALLO1 Cells will be administered intravenously as per the schedule specified in the protocol. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Dose-limiting Toxicity (DLTs) at Each Dose Level of P-CD19CD20-ALLO1 | Day 1 up to Day 29 | |
| Number of Participants With Adverse Events (AEs) | Up to 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Chimeric Antigen Receptor (CAR) Transgene Copies in Blood Assessed by Droplet Digital Polymerase Chain Reaction (ddPCR) | Up to 5 years | |
| B-cell Levels in the Blood | Up to 5 years | |
Not provided
Inclusion Criteria:
Expanded disability status scale (EDSS) score at screening, from 3 to 6 inclusive Evidence of disability progression and no relapses in the 2 years prior to screening
- Diagnosis of relapsing MS according to the revised McDonald 2017 criteria, and: Evidence of clinical relapses and MRI activity within two years prior to screening while on a disease modifying therapy
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Genentech, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCI Sue & Bill Gross Stem Cell Research Center | Irvine | California | 92697 | United States | ||
| UCSD Altman Clinical and Translational Research Institute |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Cyclophosphamide | Drug | Cyclophosphamide will be administered intravenously. |
|
| Fludarabine | Drug | Fludarabine will be administered intravenously. |
|
| Number of Participants With Anti-CAR T Antibodies |
| Up to 5 years |
| La Jolla |
| California |
| 92037-1337 |
| United States |
| Washington University School of Medicine | St Louis | Missouri | 63110-1010 | United States |
| Rutgers University- Robert Wood Johnson Medical School | New Brunswick | New Jersey | 08901-1962 | United States |
| Multiple Sclerosis Comprehensive Care Center at Northwell Health | New York | New York | 10075 | United States |
| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D003520 | Cyclophosphamide |
| C024352 | fludarabine |
| ID | Term |
|---|---|
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
Not provided
Not provided