P-CD19CD20-ALLO1 for Multiple Sclerosis

Recruiting at 13 trial locations

Overseen By Reference Study ID Number: GN45773 https://forpatients.roche.com/

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Genentech, Inc.

Must not be taking: Immunosuppressants, Immunomodulators

Disqualifiers: Pregnancy, PML, HLH/MAS, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 1 day

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine the safety and behavior of a new treatment, P-CD19CD20-ALLO1 (an experimental therapy), in the body for people with multiple sclerosis (MS). It addresses both progressive MS, where symptoms worsen over time, and relapsing MS, where symptoms fluctuate. Participants will undergo a special chemotherapy treatment before receiving a single dose of the new therapy. Ideal candidates for this trial are those with progressive MS experiencing worsening symptoms or relapsing MS with recent flare-ups despite current treatments. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.

Do I need to stop my current medications to join the trial?

The trial requires an appropriate washout period (time without taking certain medications) for any previous treatment with immunomodulatory or immunosuppressive medication. It is best to discuss your current medications with the trial team to understand what this means for you.

Is there any evidence suggesting that P-CD19CD20-ALLO1 is likely to be safe for humans?

Research has shown that P-CD19CD20-ALLO1 remains in the early stages of testing to assess its safety and tolerability. Scientists are carefully observing participants' reactions and any side effects. As an early-phase trial, limited information exists about its safety in humans.

The treatment is a type of therapy called CAR-T, which uses specially modified cells to target specific parts of the immune system. It is being tested for multiple sclerosis, a disease affecting the brain and spinal cord. Before receiving the CAR-T cells, participants undergo lymphodepletion, a pre-treatment that lowers white blood cell levels.

No specific safety data from completed studies for P-CD19CD20-ALLO1 is available yet. Since this trial is in an early phase, researchers are still determining the treatment's safety. They are closely monitoring participants for any side effects and how well they tolerate the treatment. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for multiple sclerosis, which often include immunomodulatory drugs like interferons or monoclonal antibodies, P-CD19CD20-ALLO1 offers a novel approach. This treatment uses a unique mechanism of targeting both CD19 and CD20 antigens present on B cells, which are implicated in the disease's progression. By potentially providing a more precise method to deplete harmful immune cells, researchers are excited about P-CD19CD20-ALLO1's ability to offer improved efficacy and fewer side effects compared to existing therapies.

What evidence suggests that P-CD19CD20-ALLO1 might be an effective treatment for multiple sclerosis?

Research has shown that P-CD19CD20-ALLO1, a new type of CAR-T cell therapy, has promising results in early studies. It performs well in lab tests and demonstrates strong effects in animal studies. This treatment targets specific proteins on immune cells that may play a role in multiple sclerosis, a disease where the immune system attacks the nervous system. By modifying the body's immune cells to recognize and attack these proteins, P-CD19CD20-ALLO1 aims to reduce disease activity. Although research in humans is still ongoing, these early results suggest it could be effective for people with multiple sclerosis. Participants in this trial will receive a lymphodepleting chemotherapy regimen followed by a single infusion of P-CD19CD20-ALLO1. Researchers will make dose escalation decisions after observing participants for at least 28 days for toxicity. ^{1 2 3 4 5}

Who Is on the Research Team?

Clinical Trials

Principal Investigator

Genentech, Inc.

Are You a Good Fit for This Trial?

This trial is for individuals with progressive or relapsing multiple sclerosis. Specific eligibility details are not provided, but typically participants must meet certain health standards and may be required to have a particular severity of disease.

Inclusion Criteria

I am between 18 and 60 years old.

My MS is worsening, I haven't had relapses in 2 years, and my disability score is between 3 to 6.

My disability level allows me to walk at least with a cane.

Exclusion Criteria

I am at high risk for serious bleeding or need treatments like blood transfusions.

I have a history of HLH/MAS or had neurotoxicity from past treatments.

I have a neurological condition that could be confused with multiple sclerosis.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Lymphodepleting Chemotherapy

Participants receive a lymphodepleting chemotherapy regimen

1 week

Treatment

Participants receive a single infusion of P-CD19CD20-ALLO1

1 day

Observation

Participants are observed for a minimum of 28 days for toxicity

4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• P-CD19CD20-ALLO1

Trial Overview The study tests P-CD19CD20-ALLO1 cells along with two chemotherapy drugs, Cyclophosphamide and Fludarabine, to assess their safety and effects on the body's cellular responses in multiple sclerosis patients.

How Is the Trial Designed?

Group I: Dose Escalation Experimental Treatment 3 Interventions

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.

Who Is Running the Clinical Trial?

Genentech, Inc.

Lead Sponsor

Trials

1,578

Recruited

569,000+

Ashley Magargee

Genentech, Inc.

Chief Executive Officer since 2024

MBA from Harvard University, BA from Princeton University

Levi Garraway

Genentech, Inc.

Chief Medical Officer since 2021

MD, PhD

Poseida Therapeutics, Inc., a member of the Roche Group

Collaborator

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07008378

NCT07008378 | A Study to Evaluate the Safety, Tolerability ... This study aims to explore the safety, tolerability, cellular kinetics, and pharmacodynamics of P-CD19CD20-ALLO1 in participants with progressive multiple ...

2. crisprmedicinenews.com crisprmedicinenews.com/clinical-trial/multiple-sclerosis-nct07008378/

Clinical trial: Multiple Sclerosis, (NCT07008378) This study aims to explore the safety, tolerability, cellular kinetics, and pharmacodynamics of P-CD19CD20-ALLO1 in participants with progressive multiple ...

3. poseida.com poseida.com/news/poseida-therapeutics-highlights-positive-interim-phase-1-results-for-p-bcma-allo1-and-preclinical-data-for-dual-car-t-p-cd19cd20-allo1-at-the-66th-american-society-of-hematology-ash-annual-meeting/

Release Details P-CD19CD20-ALLO1 Preclinical Data Preclinical data has demonstrated that P-CD19CD20-ALLO1 delivers high in vitro potency and strong in vivo ...

4. trial.medpath.com trial.medpath.com/clinical-trial/b3a5f952595d0398/nct07008378-p-cd19cd20-allo1-multiple-sclerosis-study

A Study to Evaluate the Safety, Tolerability, Cellular Kinetics ... This study aims to explore the safety, tolerability, cellular kinetics, and pharmacodynamics of P-CD19CD20-ALLO1 in participants with progressive multiple ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT06014762

NCT06014762 | P-CD19CD20-ALLO1 Allogeneic CAR-T ... The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure.