Is NCT07284641 recruiting in Pittsburgh, PA?

Yes, NCT07284641 is currently recruiting participants at its Pittsburgh, PA location. This common variable immunodeficiency (cvid) clinical trial is actively enrolling qualified participants.

Is participation in this Pittsburgh clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Common Variable Immunodeficiency (CVID) Clinical Trial in Pittsburgh, PA

Q: How do I join the common variable immunodeficiency (cvid) clinical trial in Pittsburgh?

To join this clinical trial in Pittsburgh, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

About This Common Variable Immunodeficiency (CVID) Study in Pittsburgh

This is a research protocol that will examine Hematopoietic Stem Cell Transplantation (HSCT) using a reduced conditioning regimen (RIC) with total body Irradiation (TBI) in those diagnosed with Common Variable Immunodeficiency (CVID) and Other Autoimmune Manifestations of Primary Immune Regulatory Disorders (PIRD).

Sponsor: Paul Szabolcs

Who Can Participate

Inclusion Criteria

Patient, parent, or legal guardian must have given written informed consent. For pediatric subjects who are developmentally able, assent or affirmation will be obtained.

Male or female, 5 through 40 years old, inclusive, at the time of informed consent.

Patients must have evidence of common variable immunodeficiency (CVID) or other autoimmune manifestation of a primary immune regulatory disorder (PIRD). Genetic screening is required by a targeting gene panel to determine presence of genetic variations that may lead to inborn errors of immunity. Examples of such diseases include, but are not limited to:

Common variable immunodeficiency (CVID)

Combined Immunodeficiency (CID)

Immune dysregulation polyendocrinopathy enteropathy X-linked (IPEX syndrome), IPEX like syndromes

Combined immunodeficiency with defects in T-cell-mediated immunity, including Omenn syndrome and DiGeorge Syndrome

Chronic Granulomatous Disease (CGD)

Signal Transducer and Activator of Transcription (STAT 1) Gain of Function (STAT1 GOF)

Signal Transducer and Activator of Transcription (STAT 3) Gain of Function (STAT3 GOF)

Hypomorphic Recombination-Activating Genes (RAG) 1 and RAG 2

CD40 or CD40L deficiency

Mendelian Susceptibility to Mycobacterial Disease

GATA-binding factor 2 (GATA2) Associated Immunodeficiency

Mouth and Genital Ulcers with Inflamed Cartilage Syndrome (MAGIC)

Must have previously failed, due to lack of response or intolerance, mycophenolate mofetil and a B cell-depleting antibody, such as Rituximab

Glomerular Filtration Rate (GFR) ≥50 mL/min/1.73 m2

Aspartate Aminotransferase (AST) ≤4x upper limit of normal

Alanine Aminotransferase (ALT) ≤4x upper limit of normal

Direct bilirubin ≤ 2.5 mg/dL

Human Immunodeficiency Virus (HIV) negative by serology and PCR

Human T-cell Lymphotropic Virus (HTLV) negative by serology

Cardiac ejection fraction ≥ 40% or shortening fraction ≥26%

Forced Vital Capacity (FVC) and Forced Expiratory Volume in 1 second (FEV1) ≥40% predicted for age

Peripheral Capillary Oxygen Saturation (SpO2) of \>92% at rest on room air

Subjects must be a minimum of 8 weeks post-solid organ transplant prior to start of conditioning, if applicable

Negative pregnancy test for females \>10 years old or who have reached menarche, unless surgically sterilized.

All females of childbearing potential and sexually active males must agree to use a FDA approved method of birth control for up to 12 months after stem cell transplant or for as long as they are taking any medication that may harm a pregnancy, an unborn child or may cause birth defects.

Subject and/or parent guardian informed of the potential risks of infertility following stem cell transplant and advised to discuss sperm banking or oocyte harvesting.

Transplant endorsement from clinical immunologist

Exclusion Criteria

Allergy to Dimethylsulfoxide (DMSO) or any other ingredient used in the manufacturing of the stem cell product

Uncontrolled systemic infection, as determined by the appropriate confirmatory testing e.g. blood cultures, Polymerase chain reaction (PCR) testing, etc.

Recent recipient of any licensed or investigational live attenuated vaccine(s) within 4 weeks of stem cell transplant

Past or current medical problems or findings from physical examination or laboratory testing that are not listed above, which, in the opinion of the investigator, may pose additional risks from participation in the study, may interfere with the subject's ability to comply with study requirements or that may impact the quality or interpretation of the data obtained from the study.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Pittsburgh?

Yes, this clinical trial (NCT07284641) has an active research site in Pittsburgh, PA that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Common Variable Immunodeficiency (CVID) Treatment Options in Pittsburgh, PA

If you're searching for common variable immunodeficiency (cvid) treatment options in Pittsburgh, PA, this clinical trial (NCT07284641) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Pittsburgh research site is actively enrolling participants for this phase 2 clinical trial. You'll receive care from experienced common variable immunodeficiency (cvid) specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all common variable immunodeficiency (cvid) clinical trials near you to find additional studies recruiting in your area.

Common Variable Immunodeficiency (CVID) Clinical Trial in Pittsburgh, PA

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