Multiple SclerosisPhase 1NCT07008378
A Study to Evaluate the Safety, Tolerability, Cellular Kinetics, and Pharmacodynamics of P-CD19CD20-ALLO1 in Participants With Multiple Sclerosis
A Phase 1 study testing P-CD19CD20-ALLO1 Cells, Cyclophosphamide and Fludarabine in people with Multiple Sclerosis, run by Genentech, Inc. at 4 sites in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- P-CD19CD20-ALLO1 Cells, Cyclophosphamide and Fludarabine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 4 sitesUnited States
- Study dates
- 15 Oct 2025to 31 Aug 2032
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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)
- Known or suspected history of Hemophagocytic Lymphohistiocytosis/ Macrophage Activation Syndrome (HLH/MAS) or neurotoxicity with prior therapies
- 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
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- 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
- 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.
- Inability to complete an MRI scan
Trial locations and contacts
4 sites in 1 country.
United States4 sites
UCSD Altman Clinical and Translational Research Institute
La Jolla, California, 92037-1337
Rutgers University- Robert Wood Johnson Medical School
New Brunswick, New Jersey, 08901-1962
Multiple Sclerosis Comprehensive Care Center at Northwell Health
New York, New York, 10075
Washington University School of Medicine
St Louis, Missouri, 63110-1010
About this study
Official title: 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
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).
- Conditions
- Multiple Sclerosis
- Being tested
- P-CD19CD20-ALLO1 Cells, Cyclophosphamide, Fludarabine
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
P-CD19CD20-ALLO1 CellsBiological
P-CD19CD20-ALLO1 Cells will be administered intravenously as per the schedule specified in the protocol.
CyclophosphamideDrug
Cyclophosphamide will be administered intravenously.
FludarabineDrug
Fludarabine will be administered intravenously.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Biological: P-CD19CD20-ALLO1 Cells; Drug: Cyclophosphamide; Drug: Fludarabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Dose-limiting Toxicity (DLTs) at Each Dose Level of P-CD19CD20-ALLO1
Measured: Day 1 up to Day 29
Number of Participants With Adverse Events (AEs)
Measured: Up to 5 years
Secondary outcomes (3)
Number of Chimeric Antigen Receptor (CAR) Transgene Copies in Blood Assessed by Droplet Digital Polymerase Chain Reaction (ddPCR)
Measured: Up to 5 years
B-cell Levels in the Blood
Measured: Up to 5 years
Number of Participants With Anti-CAR T Antibodies
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2025
- Study start15 Oct 2025
- Primary completion31 Aug 2032 (estimated)
- Study completion31 Aug 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by Genentech, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Genentech, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Poseida Therapeutics, Inc., a member of the Roche Group
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Genentech, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07008378
- Sponsor's protocol ID
- GN45773
- Status last verified
- Oct 2026
- First submitted
- 20 May 2025
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07008378
- Acronym / sponsor ID
- GN45773
- Conditions
- Multiple Sclerosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Genentech, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Poseida Therapeutics, Inc., a member of the Roche Group
- Study start
- 15 Oct 2025 (actual)
- Primary completion
- 31 Aug 2032 (estimated)
- Study completion
- 31 Aug 2032 (estimated)
- First posted
- 6 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dose Escalation | Experimental | Biological: P-CD19CD20-ALLO1 Cells, Drug: Cyclophosphamide, Drug: FludarabineParticipants 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (11 listed)
- 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)
- Known or suspected history of Hemophagocytic Lymphohistiocytosis/ Macrophage Activation Syndrome (HLH/MAS) or neurotoxicity with prior therapies
- Known presence of other neurologic disorders that may mimic MS
- History of currently active primary or secondary (non-drug-related) immunodeficiency
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| P-CD19CD20-ALLO1 CellsP-CD19CD20-ALLO1 Cells will be administered intravenously as per the schedule specified in the protocol. | Biological | Dose Escalation |
| CyclophosphamideCyclophosphamide will be administered intravenously. | Drug | Dose Escalation |
| FludarabineFludarabine will be administered intravenously. | Drug | Dose Escalation |
Primary outcome
Number of Participants With Dose-limiting Toxicity (DLTs) at Each Dose Level of P-CD19CD20-ALLO1
Time frame: Day 1 up to Day 29
Number of Participants With Adverse Events (AEs)
Time frame: Up to 5 years
3 secondary outcomes
Number of Chimeric Antigen Receptor (CAR) Transgene Copies in Blood Assessed by Droplet Digital Polymerase Chain Reaction (ddPCR)
Time frame: Up to 5 years
B-cell Levels in the Blood
Time frame: Up to 5 years
Number of Participants With Anti-CAR T Antibodies
Time frame: Up to 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trials study director
Genentech, Inc.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing P-CD19CD20-ALLO1 Cells, Cyclophosphamide and Fludarabine in people with Multiple Sclerosis, run by Genentech, Inc. at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Dose-limiting Toxicity (DLTs) at Each Dose Level of P-CD19CD20-ALLO1 (time frame: Day 1 up to Day 29). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.