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Monoclonal Antibodies

JSP191 for Chronic Granulomatous Disease

Q: Is there still capacity in this research project for new participants?

Unfortunately, this clinical trial is no longer in the process of recruiting patients. Initially posted on December 6th 2022 and last updated November 30th 2022, it has since ceased to look for new participants; however, there are 21 other trials that remain receptive to new enrollees.

Q: Is this research endeavor accepting volunteers who are 50 years or older?

The eligibility criteria for this medical experiment necessitates that participants are between 4 and 65 years of age. Simultaneously, there are 15 studies open to minors and 13 trials accessible for individuals over the age of 65.

Q: Is it possible for me to join this research endeavor?

This clinical trial is seeking to enrol 30 individuals aged 4-65 years who are diagnosed with Chronic Granulomatous Disease (CGD). To be admitted, participants must meet the following conditions: demonstrate CGD symptoms and complications; have an unrelated donor ready for transplantation or a Quartile 1/2 oxidase production level; reside within one hour of NIH upon post-<a href="https://www.withpower.com/clinical-trials/transplant">transplant</a> period commencement; appoint a responsible adult relative as Durable Power of Attorney for Health Care Decision Making through form NIH 200. Additionally, female patients require contraceptive methods such as oral pills, patches, Norplant implants, Depo-Provera injections etc

Phase < 1

Recruiting

Led By Elizabeth M Kang, M.D.

Research Sponsored by National Institute of Allergy and Infectious Diseases (NIAID)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 100 and 2 years post transplant

Awards & highlights

Study Summary

This trial tests if a study drug (JSP191) can improve success of stem cell transplants for people 4-65 w/ Chronic Granulomatous Disease.

Who is the study for?

This trial is for people aged 4-65 with Chronic Granulomatous Disease (CGD) needing a stem cell transplant and have an unrelated matched donor. Participants must be able to stay near the NIH for 3 months post-transplant, use contraception, and not have major illnesses or organ failure that could affect survival after the transplant.Check my eligibility

What is being tested?

The study tests JSP191 in patients with CGD undergoing stem cell transplants from unrelated donors. It aims to improve success rates by including a conditioning phase where JSP191 is administered intravenously before the actual transplant procedure.See study design

What are the potential side effects?

While specific side effects of JSP191 are not listed here, similar treatments may include reactions at the infusion site, potential infection risks due to immune system suppression during transplantation, and general discomfort associated with hospital stays.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 100 and 2 years post transplant

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 100 and 2 years post transplant

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 100 and 2 years post transplant for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Early and long term engraftment

Secondary outcome measures

Incidence of graft-vs-host disease (GvHD)

Incidence of viral reactivation

Safety

Trial Design

1Treatment groups

Experimental Treatment

Group I: Single arm studyExperimental Treatment1 Intervention

Eligible CGD patients will receive one time infusion of study product along with Alemtuzumab and TBI as part of HSCT conditioning regimen

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

National Institute of Allergy and Infectious Diseases (NIAID)Lead Sponsor

3,269 Previous Clinical Trials

5,481,439 Total Patients Enrolled

Elizabeth M Kang, M.D.Principal InvestigatorNational Institute of Allergy and Infectious Diseases (NIAID)

11 Previous Clinical Trials

364 Total Patients Enrolled

Media Library

JSP191 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05600907 — Phase < 1

Chronic Granulomatous Disease Research Study Groups: Single arm study

Chronic Granulomatous Disease Clinical Trial 2023: JSP191 Highlights & Side Effects. Trial Name: NCT05600907 — Phase < 1

JSP191 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05600907 — Phase < 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there still capacity in this research project for new participants?

"Unfortunately, this clinical trial is no longer in the process of recruiting patients. Initially posted on December 6th 2022 and last updated November 30th 2022, it has since ceased to look for new participants; however, there are 21 other trials that remain receptive to new enrollees."

Answered by AI

Is this research endeavor accepting volunteers who are 50 years or older?

"The eligibility criteria for this medical experiment necessitates that participants are between 4 and 65 years of age. Simultaneously, there are 15 studies open to minors and 13 trials accessible for individuals over the age of 65."

Answered by AI

Is it possible for me to join this research endeavor?

"This clinical trial is seeking to enrol 30 individuals aged 4-65 years who are diagnosed with Chronic Granulomatous Disease (CGD). To be admitted, participants must meet the following conditions: demonstrate CGD symptoms and complications; have an unrelated donor ready for transplantation or a Quartile 1/2 oxidase production level; reside within one hour of NIH upon post-transplant period commencement; appoint a responsible adult relative as Durable Power of Attorney for Health Care Decision Making through form NIH 200. Additionally, female patients require contraceptive methods such as oral pills, patches, Norplant implants, Depo-Provera injections etc"

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study to Assess the Use of JSP191 in Matched Unrelated Donor Transplantation for Chronic Granulomatous Disease (CGD)

2023. "Study to Assess the Use of JSP191 in Matched Unrelated Donor Transplantation for Chronic Granulomatous Disease (CGD)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05600907.