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Monoclonal Antibodies

JSP191 for Severe Combined Immunodeficiency (SCID)

Phase 1 & 2

Recruiting

Led By Susan E. Prockop, M.D.

Research Sponsored by Jasper Therapeutics, Inc.

Eligibility Criteria Checklist

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

Must have

Patients with human leukocyte antigen (HLA) matched related or unrelated donors

Patients with Typical SCID as defined by Primary Immune Deficiency Treatment Consortia including specified subtypes

Timeline

Screening 3 weeks

Treatment Varies

Follow Up weeks 36-104 post donor cell transplant

Awards & highlights

Study Summary

This trial is testing a new antibody conditioning regimen to see if it is safe and effective in people with Severe Combined Immune Deficiency who are undergoing blood stem cell transplantation.

Who is the study for?

This trial is for patients with Severe Combined Immunodeficiency (SCID) who have a matching donor for blood stem cell transplantation. They must have normal organ function and typical SCID as defined by specific criteria. People with active cancer, ongoing treatments like chemotherapy or radiation, uncontrolled infections, or recent graft-versus-host disease are not eligible.Check my eligibility

What is being tested?

The study is testing the safety and effectiveness of JSP191, a humanized anti-CD117 monoclonal antibody used as part of the conditioning regimen before blood stem cell transplants in SCID patients. This Phase 1/2 trial will assess how well patients tolerate this new treatment approach.See study design

What are the potential side effects?

While specific side effects of JSP191 are not detailed here, monoclonal antibodies can cause allergic reactions, infusion-related symptoms such as fever or chills, potential organ inflammation, and may affect immune system responses.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have a donor who matches my HLA type.

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I have been diagnosed with a specific type of severe combined immunodeficiency.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ weeks 36-104 post donor cell transplant

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~weeks 36-104 post donor cell transplant

This trial's timeline: 3 weeks for screening, Varies for treatment, and weeks 36-104 post donor cell 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

Phase 1: Safety and tolerability of JSP191 as conditioning therapy in SCID patients undergoing HCT: adverse events

Phase 2: Efficacy of JSP191 as conditioning therapy in SCID patients

Trial Design

1Treatment groups

Experimental Treatment

Group I: Blood Stem Cell Transplant w/ anti-CD117 conditioningExperimental Treatment1 Intervention

The study will enroll two groups: Group A: previously transplanted SCID patients; Group B: newly diagnosed SCID. The study plans to assess JSP191 in different dose cohorts. Patients will receive a single dose of intravenous JSP191 antibody followed by monitoring for antibody clearance. Once the antibody has cleared below a certain level, patients will receive stem cell transplant and be monitored for hematopoietic recovery.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Jasper Therapeutics, Inc.Lead Sponsor

4 Previous Clinical Trials

132 Total Patients Enrolled

Susan E. Prockop, M.D.Principal InvestigatorMemorial Sloan Kettering Cancer Center

Rajni A. Agarwal-Hashmi, M.D.Principal InvestigatorLucile Packard Children's Hospital

Media Library

Severe Combined Immunodeficiency Clinical Trial 2023: JSP191 Highlights & Side Effects. Trial Name: NCT02963064 — Phase 1 & 2

JSP191 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02963064 — Phase 1 & 2

Frequently Asked Questions

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

Are there any vacancies available for this research endeavor?

"Affirmative, the information on clinicaltrials.gov confirms that this medical trial is actively seeking participants. The study was first posted in March 20th 2017 and has been updated as recent as November 16 2021. 40 patients have to be enrolled from 8 various sites around the country."

Answered by AI

How many venues are offering access to this clinical investigation?

"At present, 8 sites throughout the United States are running this trial. These include Atlanta, New york, Bethesda and a few other cities. To reduce travel inconveniences for enrolled patients it is suggested to select the closest site available."

Answered by AI

How many participants have been accepted into this clinical research project?

"40 eligible participants are sought to participate in this trial, which can be conducted at sites such as Children's Healthcare of Atlanta (Atlanta, Georgia) and Memorial Sloan Kettering Cancer Center (New york City)."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

JSP191 Antibody Targeting Conditioning in SCID Patients

2017. "JSP191 Antibody Targeting Conditioning in SCID Patients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02963064.