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P-CD19CD20-ALLO1 Cells

Phase 1

Multiple Sclerosis | Monoclonal antibody | Neurology |Roche Holding AG|Last Updated: Jul 15, 2026

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment60

FDA Designations

No designations recorded

Clinical trial landscape

P-CD19CD20-ALLO1 Cells · 1 trial · 1 indication

Phase 1 1
NCT07008378A Study to Evaluate the Safety, Tolerability, Cellular Kinetics, and Pharmacodynamics of P-CD19CD20-ALLO1 in Participants With Multiple SclerosisMultiple Sclerosis
ACTIVE NOT_RECRUITING60 Analytics
PHASE1ACTIVE NOT_RECRUITING
A Study to Evaluate the Safety, Tolerability, Cellular Kinetics, and Pharmacodynamics of P-CD19CD20-ALLO1 in Participants With Multiple Sclerosis
Multiple SclerosisUnlock trial analytics

Study Endpoints

Primary Endpoints

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

Secondary Endpoints

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
Number of Participants With Anti-CAR T Antibodies
Up to 5 years
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Dose EscalationEXPERIMENTALParticipants 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.

Interventions

NameTypeDescription
P-CD19CD20-ALLO1 CellsBIOLOGICALP-CD19CD20-ALLO1 Cells will be administered intravenously as per the schedule specified in the protocol.
CyclophosphamideDRUGCyclophosphamide will be administered intravenously.
FludarabineDRUGFludarabine will be administered intravenously.
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Eligibility Criteria

Age Range18 Years to 60 Years
SexALL
Healthy VolunteersNo
Study Sites5

Inclusion Criteria: * 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 an...

Countries:United States
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Recent Changes (Last 90 Days)

LOWJul 15, 2026NCT07008378lastUpdatePostDate: changed
LOWJul 15, 2026NCT07008378lastUpdatePostDate: changed

Frequently asked questions about P-CD19CD20-ALLO1 Cells

What is P-CD19CD20-ALLO1 Cells used for in Multiple Sclerosis?

P-CD19CD20-ALLO1 Cells is an investigational cell therapy being studied for the treatment of Multiple Sclerosis. It is currently in Phase 1 clinical development, with an active clinical trial evaluating its safety, tolerability, cellular kinetics, and pharmacodynamics in participants with Multiple Sclerosis.

Who makes P-CD19CD20-ALLO1 Cells?

P-CD19CD20-ALLO1 Cells is being developed by Roche Holding AG, which trades under the ticker RHHBY. The company is conducting a Phase 1 clinical trial of this investigational therapy in the United States for Multiple Sclerosis.

What phase is P-CD19CD20-ALLO1 Cells in?

P-CD19CD20-ALLO1 Cells is in Phase 1 clinical development. It is an investigational therapy, not yet approved, and is being studied in an active clinical trial for Multiple Sclerosis. The trial is currently active but not recruiting participants.

What clinical trials is P-CD19CD20-ALLO1 Cells in?

P-CD19CD20-ALLO1 Cells is being evaluated in a Phase 1 clinical trial with the identifier NCT07008378. This study is assessing the safety, tolerability, cellular kinetics, and pharmacodynamics of the therapy in participants with Multiple Sclerosis. The trial is active but not recruiting, with an enrollment of 60 participants.

Is P-CD19CD20-ALLO1 Cells FDA approved?

P-CD19CD20-ALLO1 Cells is not FDA approved. It is an investigational therapy currently in Phase 1 clinical development for Multiple Sclerosis. The ongoing clinical trial is designed to evaluate its safety and other characteristics, but it has not yet received regulatory approval.