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39 Participants NeededMy employer runs this trial

TRX319 + Bendamustine for Multiple Sclerosis

(IMPACT-MS Trial)

Recruiting at 1 trial location
TC
ST
Overseen ByStudy Team
Age: 18+
Sex: Any
Trial Phase: Phase 1 & 2
Sponsor: Tr1X, Inc.
Must not be taking: CAR-T, Chemotherapies, CD20 antibodies, others
Disqualifiers: HIV, Hepatitis B/C, Cardiac disease, others
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

The goal of this clinical trial is to treat male and female participants with two types of Multiple Sclerosis (MS) called primary progressive or secondary progressive MS.

The main questions the trial aims to answer are the following:

* Is TRX319 safe when administered to patients with progressive forms of MS?

* At what dose does TRX319 work the best to treat participants with primary and or secondary progressive MS?

* Is pre-conditioning (with Bendamustine) needed to allow TRX319 to better treat participants with primary and/or secondary progressive MS?

Participants will be asked to be on study for up 1 year and may receive up to 3 total administrations of TRX319. While on study, participants will have blood tests and other assessments (MRI scans and lumbar punctures) done to understand the safety of TRX319 and how it may benefit their multiple sclerosis.

Are You a Good Fit for This Trial?

Inclusion Criteria

4. Documented presence of CSF-restricted OCBs and/or elevated IgG index and/or κ free light chain.
I am a woman who can have children and my pregnancy test is negative.
8. Contraceptive use by all participants while on study.
See 7 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-conditioning

Participants may receive pre-conditioning with Bendamustine to enhance the efficacy of TRX319

2-4 weeks

Treatment

Participants receive up to 3 administrations of TRX319 and undergo blood tests, MRI scans, and lumbar punctures to assess safety and efficacy

12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments at 3, 6, and 12 months post-infusion

12 months

What Are the Treatments Tested in This Trial?

Interventions

  • Bendamustine
  • TRX319

How Is the Trial Designed?

6

Treatment groups

Experimental Treatment

Group I: Cohort 3AExperimental Treatment2 Interventions
Group II: Cohort 3Experimental Treatment1 Intervention
Group III: Cohort 2AExperimental Treatment2 Interventions
Group IV: Cohort 2Experimental Treatment1 Intervention
Group V: Cohort 1AExperimental Treatment2 Interventions
Group VI: Cohort 1Experimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Tr1X, Inc.

Lead Sponsor

Trials
2
Recruited
60+

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