Treatment of a Single Patient With CRD-TMH-001

NCT ID: NCT05514249

Last Updated: 2022-09-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

1 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-31

Study Completion Date

2023-09-30

Brief Summary

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The study is a single patient study intended to understand the effects of a gene-editing therapeutic to treat a rare mutation of Duchenne muscular dystrophy.

Detailed Description

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The objective of the study is to assess the safety and preliminary efficacy of CRD-TMH-001 after intravenous administration for a period of 1 year with long-term follow-up out to 15 years.

Conditions

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Duchenne Muscular Dystrophy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Single patient clinical trial

Study Groups

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Single patient

Single dose of CRD-TMH-001 administered by IV

Group Type EXPERIMENTAL

CRD-TMH-001

Intervention Type DRUG

Participant will receive a single dose of CRD-TMH-001 administered via intravenous injection.

Interventions

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CRD-TMH-001

Participant will receive a single dose of CRD-TMH-001 administered via intravenous injection.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Completion of informed consent
* Confirmation of genetic mutation
* Confirmation of absence of elevated AAV9 NAbs

Exclusion Criteria

\- Any significant medical issue(s) (past or current) that would, in the opinion of the Principal Investigator (PI), prevent this patient from being dosed.
Minimum Eligible Age

18 Years

Maximum Eligible Age

28 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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University of Massachusetts, Worcester

OTHER

Sponsor Role collaborator

Cure Rare Disease, Inc

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Brenda Wong, MD

Role: PRINCIPAL_INVESTIGATOR

UMass Chan Medical School

Medical Affairs

Role: STUDY_DIRECTOR

Cure Rare Disease

Locations

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UMass Chan Medical School

Worcester, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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CS-CRD-TMH-001

Identifier Type: -

Identifier Source: org_study_id

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