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Prevention study for Hematologic Malignancies
Official title IVIG for Infection Prevention After CAR-T-Cell Therapy
ClinicalTrials.gov ID: NCT05952804
What this study is testing
What is Immune Globulin Infusion (Human), 10% Solution?
Immune Globulin Infusion (Human), 10% Solution is an investigational medicine, given as a monthly infusion into a vein, being studied as a potential treatment for hematologic malignancies.
Also referred to as GAMMAGARD LIQUID.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This phase II trial compares the effects of immunoglobulin replacement therapy with a placebo for preventing infectious complications in patients receiving CD19 chimeric antigen receptor (CAR)-T cell therapy. Hypogammaglobulinemia is a common complication in patients who receive CD19 CAR-T cell therapy.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 4 months
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Capable of understanding the investigational nature, potential risks and benefits of the study, and able to provide valid informed consent
- For patients with medical incapacity or impaired consciousness such that they are not able to give fully informed voluntary consent, the people'...
- Participants must be 18 years of age or older
- Participants will receive an Food and Drug Administration (FDA)-approved CD19-CAR T-cell product for the treatment of hematologic malignancies...
- Serum total IgG \< 600mg/dL within the prior three months
You likely can't join if
- Primary congenital selective IgA deficiency
- Prior serious adverse event/s related to intravenous immune globulin (IVIG) administration
- Known serious allergy to any component of IVIG
- Has a history or current evidence of any condition, therapy, lab abnormality, or other circumstance that might confound the results of the study or...
- SUBSEQUENT INFUSIONS: Ongoing symptoms of cytokine release syndrome (CRS) and/or immune effector cell-associated neurotoxicity syndrome (ICANS)...
- SUBSEQUENT INFUSIONS: Primary congenital selective IgA deficiency
See the full eligibility criteria
- Capable of understanding the investigational nature, potential risks and benefits of the study, and able to provide valid informed consent
- For patients with medical incapacity or impaired consciousness such that they are not able to give fully informed voluntary consent, the people' legal representative must sign an institutional review board (IRB)...
- Participants must be 18 years of age or older
- Participants will receive an Food and Drug Administration (FDA)-approved CD19-CAR T-cell product for the treatment of hematologic malignancies. Patients receiving an FDA-approved product are eligible even if the product...
- Serum total IgG \< 600mg/dL within the prior three months
- Note, if there are additional results ≥ 600 mg/dL within the prior three months, but the patient is receiving IVIG, they remain eligible
- SUBSEQUENT INFUSIONS: Received an FDA-approved CD19-CAR T-cell product for the treatment of hematologic malignancies
- Primary congenital selective IgA deficiency
- Prior serious adverse event/s related to intravenous immune globulin (IVIG) administration
- Known serious allergy to any component of IVIG
- Has a history or current evidence of any condition, therapy, lab abnormality, or other circumstance that might confound the results of the study or interfere with the patient's ability to participate for the full...
- SUBSEQUENT INFUSIONS: Ongoing symptoms of cytokine release syndrome (CRS) and/or immune effector cell-associated neurotoxicity syndrome (ICANS) meeting criteria for grade 3 or higher
- SUBSEQUENT INFUSIONS: Primary congenital selective IgA deficiency
- SUBSEQUENT INFUSIONS: Has a history or current evidence of any condition, therapy, lab abnormality, or other circumstance that might confound the results of the study or interfere with the patient's ability to...
- SUBSEQUENT INFUSIONS: Receipt of additional therapy for persistence or relapse of the patient's primary malignancy for which they underwent CARTx
- SUBSEQUENT INFUSIONS: Receipt of bone marrow transplant (allogeneic or autologous) after CARTx
- SUBSEQUENT INFUSIONS: Any serious adverse event (SAE), clinically significant adverse event (AE), severe laboratory abnormality, intercurrent illness, or other medical condition that indicates to the Investigator that...
The study team makes the final eligibility decision.
Where it's taking place
- Duarte, California, United States
- Miami, Florida, United States
- Tampa, Florida, United States
- Boston, Massachusetts, United States
- New York, New York, United States
- Portland, Oregon, United States
- Seattle, Washington, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 4 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Duarte, California, United States; Miami, Florida, United States; Tampa, Florida, United States; Boston, Massachusetts, United States; New York, New York, United States; Portland, Oregon, United States and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.