150 Participants Needed

IVIG for Infection Prevention After Lymphoma Treatment

Recruiting at 4 trial locations
JH
JA
Overseen ByJoshua A. Hill
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Fred Hutchinson Cancer Center
Must be taking: CD19-CAR T-cell
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 4 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

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. This is a condition in which the level of immunoglobulins (antibodies) in the blood is low and the risk of infection is high. Immunoglobulin replacement therapy works by replacing the body's immunoglobulin G (IgG) antibodies with donor blood product derived IgG antibodies that may help prevent infection. IgG antibodies are often depleted as a result of CAR-T therapy. Giving immunoglobulin replacement therapy may prevent infectious complications in patients receiving CD19 CAR-T cell therapy.

Do I need to stop my current medications to join the trial?

The trial protocol does not specify whether you need to stop taking your current medications. It's best to discuss your specific situation with the trial team or your doctor.

Is IVIG for infection prevention after lymphoma treatment generally safe?

Anti-CD19 CAR T-cell therapy, which is related to IVIG, has shown potential in treating B-cell malignancies but can cause side effects like increased infection risk and acute neurotoxicity. Some patients experience reversible toxicities linked to inflammation, but these treatments are still considered promising for certain cancers.12345

How is Anti-CD19 CAR-T Cell Therapy different from other treatments for lymphoma?

Anti-CD19 CAR-T Cell Therapy is unique because it uses a patient's own T-cells, which are modified to specifically target and attack cancer cells with the CD19 marker, offering a new option for those with aggressive B-cell lymphomas that do not respond to traditional chemotherapy.16789

What data supports the effectiveness of the treatment IVIG for Infection Prevention After Lymphoma Treatment?

Research shows that CD19 CAR-T cell therapy is effective for treating relapsed or refractory lymphoma, although it can increase infection risk. The use of immune globulin infusions (IVIG) may help prevent infections in these patients, as IVIG is known to support the immune system.19101112

Who Is on the Research Team?

JH

Joshua A. Hill

Principal Investigator

Fred Hutch/University of Washington Cancer Consortium

Are You a Good Fit for This Trial?

This trial is for adults with lymphoma who are getting FDA-approved CD19-CAR T-cell therapy and have low levels of IgG antibodies. They must understand the study's risks and benefits, give informed consent, or have a legal representative do so if they're unable to. People with past IVIG issues, serious allergies to IVIG components, or conditions that could risk their safety or skew results can't join.

Inclusion Criteria

I have received an FDA-approved CAR T-cell therapy for lymphoma.
I will receive an FDA-approved CAR T-cell therapy for lymphoma.
If I'm unable to consent, my legal representative will sign for me.
See 2 more

Exclusion Criteria

Known serious allergy to any component of IVIG
Prior serious adverse event/s related to intravenous immune globulin (IVIG) administration
I have a condition where my body lacks enough IgA antibodies.
See 7 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2 weeks
1 visit (in-person)

Pre-Treatment

Participants receive either immunoglobulin replacement therapy or placebo within 14 days prior to CD19 CAR-T-cell infusion

2 weeks
1 visit (in-person)

Treatment

Participants undergo CD19 CAR-T-cell therapy and receive monthly infusions of either IVIG or placebo for up to 4 months

4 months
4 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with monthly follow-ups for up to 6 months post CAR-T-cell infusion

6 months
6 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • Anti-CD19-targeting CAR-T Cells
  • Immune Globulin Infusion (Human), 10% Solution
Trial Overview The trial is testing whether giving immunoglobulin replacement therapy (IVIG) after CAR-T cell treatment can prevent infections better than a placebo. Participants will either receive human immune globulin infusions or saline as a control while being monitored through surveys and health record reviews.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Arm I (therapeutic immune globulin)Experimental Treatment5 Interventions
Group II: Arm II (normal saline)Placebo Group5 Interventions

Anti-CD19-targeting CAR-T Cells is already approved in United States, European Union, Canada, Japan for the following indications:

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Approved in United States as CAR-T Cell Therapy for:
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Approved in European Union as CAR-T Cell Therapy for:
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Approved in Canada as CAR-T Cell Therapy for:
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Approved in Japan as CAR-T Cell Therapy for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Fred Hutchinson Cancer Center

Lead Sponsor

Trials
583
Recruited
1,341,000+

Takeda

Industry Sponsor

Trials
1,255
Recruited
4,219,000+
Dr. Naoyoshi Hirota profile image

Dr. Naoyoshi Hirota

Takeda

Chief Medical Officer since 2020

MD from University of Tokyo

Christophe Weber profile image

Christophe Weber

Takeda

Chief Executive Officer since 2015

PhD in Molecular Biology from Universitรฉ de Montpellier

National Cancer Institute (NCI)

Collaborator

Trials
14,080
Recruited
41,180,000+

Published Research Related to This Trial

In a study of 50 patients receiving CD19 CAR-T cell therapy, 36% experienced infectious complications, with a median time to infection of 225 days, indicating that infections can occur well after treatment.
Severe infections were common, with 54.8% leading to significant health issues, including hospitalization and even death in 6% of patients, highlighting the need for ongoing monitoring and improved antimicrobial prophylaxis strategies.
Infectious complications among CD19 CAR-T cell therapy recipients: A single-center experience.Walker, B., Zimmer, AJ., Stohs, EJ., et al.[2023]
CAR-T cell therapy combined with anti-PD-1 immunotherapy shows promising efficacy in treating lymphoma, with an overall response rate of 65% based on an analysis of 57 patients from 5 clinical trials.
The most common adverse effect observed was fever, with a pooled incidence of 59%, indicating that while the therapy is effective, it does come with notable side effects.
Ray of dawn: Anti-PD-1 immunotherapy enhances the chimeric antigen receptor T-cell therapy in Lymphoma patients.Zhou, Y., Mu, W., Wang, C., et al.[2023]
CD79b is widely expressed on tumor cells in various types of B-cell lymphomas, making it a promising target for CAR T-cell therapy.
Anti-CD79b CAR T-cells demonstrated high specificity and effectiveness in treating B-cell lymphomas, suggesting that targeting CD79b could improve outcomes for patients who do not respond to existing therapies.
Targeting CD79b for Chimeric Antigen Receptor T-Cell Therapy of B-Cell Lymphomas.Ding, S., Mao, X., Cao, Y., et al.[2021]

Citations

Infectious complications among CD19 CAR-T cell therapy recipients: A single-center experience. [2023]
Ray of dawn: Anti-PD-1 immunotherapy enhances the chimeric antigen receptor T-cell therapy in Lymphoma patients. [2023]
Targeting CD79b for Chimeric Antigen Receptor T-Cell Therapy of B-Cell Lymphomas. [2021]
CAR T-Cell Therapy for Relapsed/Refractory Aggressive Large B-Cell Lymphoma. [2023]
Chimeric antigen receptor T-cell therapy following autologous transplantation for secondary central nervous system lymphoma: A case report. [2022]
Long-term Neurologic Safety in Patients With B-Cell Lymphoma Treated With Anti-CD19 Chimeric Antigen Receptor T-Cell Therapy. [2023]
Treating B-cell cancer with T cells expressing anti-CD19 chimeric antigen receptors. [2021]
B-cell depletion and remissions of malignancy along with cytokine-associated toxicity in a clinical trial of anti-CD19 chimeric-antigen-receptor-transduced T cells. [2023]
CAR T-Based Therapies in Lymphoma: A Review of Current Practice and Perspectives. [2023]
10.United Statespubmed.ncbi.nlm.nih.gov
Anti-CD19 CAR T-Cell Therapy for B-Cell Non-Hodgkin Lymphoma. [2021]
Successful treatment of a case with synchronous follicular lymphoma and gastric adenocarcinoma with CD19 CAR T cells and literature review. [2022]
Engineered CD20-specific primary human cytotoxic T lymphocytes for targeting B-cell malignancy. [2017]
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