NCT07008378Active, not recruitingPhase 1
A Study to Evaluate the Safety, Tolerability, Cellular Kinetics, and Pharmacodynamics of P-CD19CD20-ALLO1 in Participants With Multiple Sclerosis
A Phase I, Multicenter, Open-Label Study to Evaluate the Safety, Tolerability, Cellular Kinetics, and Pharmacodynamics of P-CD19CD20-ALLO1 in Patients With Multiple Sclerosis
Source: ClinicalTrials.gov · Last updated 13 Oct 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 20 May 2025
- Start date
- 15 Oct 2025
- Primary completion date
- 31 Aug 2032
- Lead sponsor
- Genentech, Inc.
- Diseases
- Multiple sclerosis
- NCT number
- NCT07008378
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 60
- From 15 Oct 2025 to the primary completion date, 31 Aug 2032
- 4 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Known or suspected history of Hemophagocytic Lymphohistiocytosis/ Macrophage Activation Syndrome (HLH/MAS) or neurotoxicity with prior therapies
- Prior treatment with CAR T-cell therapy, gene-therapy product, total body irradiation, bone marrow transplantation, allograft organ transplant, or hematopoietic stem cell transplant at any point
- Any previous treatment with immunomodulatory or immunosuppressive medication without an appropriate washout period.
Other illness
- Known presence of other neurologic disorders that may mimic MS
- History of currently active primary or secondary (non-drug-related) immunodeficiency
- Significant or uncontrolled medical disease which would preclude patient participation
- High risk for clinically significant bleeding or any condition requiring plasmapheresis, IV Ig, or acute blood product transfusions
- History of recurrent serious infections or chronic infection
Other
- Pregnant or breastfeeding, or intention of becoming pregnant within the timeframe in which contraception is required
- Participants who have confirmed or suspected Progressive Multifocal Leukoencephalopathy (PML)
- Inability to complete an MRI scan
Who the study is looking for
- Age 18-60 years (inclusive) at the time of signing Informed Consent Form
- Diagnosis of progressive MS according to the revised McDonald 2017 criteria, and:
- 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
- EDSS score at screening, from 0 to 6 inclusive
- No relapses within 45 days of screening
Age in the registry: 18 years to 60 years · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| UCSD Altman Clinical and Translational Research Institute Coordinator of this site? Confirm its status | La Jolla | United States | Unknown status |
| Rutgers University - Robert Wood Johnson Medical School Coordinator of this site? Confirm its status | New Brunswick | United States | Unknown status |
| Multiple Sclerosis Comprehensive Care Center at Northwell Health Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Washington University School of Medicine Coordinator of this site? Confirm its status | St Louis | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.