Vaccine Responses in Patient With Multiple Myeloma and Non-Hodgkin Lymphoma After CAR-T Treatment

September 8, 2025 updated by: Amrita Desai, M.D., OHSU Knight Cancer Institute

Vaccine Responses in Patient With Multiple Myeloma and Non-Hodgkins Lymphoma Post CAR-T Treatment

This study evaluates immune responses after CAR-T therapy to find out if CAR-T therapy reduces the effectiveness of the vaccines (vaccine immunity) against diseases such as measles, mumps and rubella, among others in patients with multiple myeloma and non-Hodgkin lymphoma.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

PRIMARY OBJECTIVES:

I. To assess positive VPD antibody (Ab) titers prior to and at 6 months after CAR-T therapy to evaluate the impact of CAR-T on immune responses in patients undergoing CAR-T therapy.

II. To assess the change in Ab titer to S. pneumoniae and tetanus at 6 months and 1 year post-vaccination and evaluate if titer increases are correlated to post-vaccination CD4+ count and IgG level.

OUTLINE: This is an observational study.

Patients may receive up to 3 doses of pneumococcal and/or tetanus vaccine per institutional policy of revaccination. Patients undergo blood sample collection and have medical records reviewed throughout the study.

Study Type

Observational

Enrollment (Estimated)

45

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Oregon
      • Portland, Oregon, United States, 97239
        • Recruiting
        • OHSU Knight Cancer Institute
        • Contact:
        • Principal Investigator:
          • Amrita Desai

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with multiple myeloma and non-hodgkin lymphoma recruited through OHSU Knight Cancer Institute

Description

Inclusion Criteria:

  • * Willingness to provide written informed consent before any study-specific procedures or activities are performed

    • Age ≥ 18 years of age, at the time of consent
    • Documented, histologically or cytologically confirmed diagnosis of multiple myeloma (MM), diffuse large B cell lymphoma (DLBCL),follicular lymphoma (FL), mantle cell lymphoma (MCL), chronic lymphocytic leukemia (CLL), or small lymphocytic lymphoma (SLL), or primary mediastinal B cell lymphoma (PMBL). All number of prior lines of therapy are allowed
    • History of prior vaccination against common VPD
    • Approved by managing physician for CAR-T therapy, with preparative conditioning planned within the next 90 days
    • Approved by managing physician for revaccination against Streptococcus pneumoniae or tetanus

Exclusion Criteria:

  • * Ongoing use of immunosuppressive agents or plans for immunosuppressive therapy that would interfere with interpretation of study endpoints

    • Uncontrolled, intercurrent illness including, but not limited to, systemic infection, symptomatic congestive heart failure, unstable angina pectoris, or psychiatric illness/social situations that would limit compliance with study requirements or make the study procedures unadvisable

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Observational
Patients may receive up to 3 doses of pneumococcal and/or tetanus vaccine per institutional policy of revaccination. Patients undergo blood sample collection and have medical records reviewed throughout the study.
Other: Non-Interventional Study
Non-interventional study

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Preserved immunity
Time Frame: Up to 12 months after CAR-T cell infusion
Will be defined as titers that meet the definition of positive both pre- and post-CAR-T cell infusion. The proportion of subjects who have preserved immunity to each VPD will be estimated with an exact 95% confidence interval.
Up to 12 months after CAR-T cell infusion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in antibody titers
Time Frame: At baseline, at 6 months and at 1 year after vaccination
Immune reconstitution will be reported based on ELISA assays for S. pneumoniae or tetanus after each dose of respective vaccine for the re-vaccination populations. Will be correlated with the changes of CD4+ and IgG using a Spearman correlation coefficient.
At baseline, at 6 months and at 1 year after vaccination

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

OHSU Knight Cancer Institute

Collaborators

Oregon Health and Science University

Investigators

  • Principal Investigator: Amrita Desai, OHSU Knight Cancer Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 10, 2025

Primary Completion (Estimated)

January 11, 2027

Study Completion (Estimated)

April 12, 2027

Study Registration Dates

First Submitted

January 14, 2025

First Submitted That Met QC Criteria

January 14, 2025

First Posted (Actual)

January 20, 2025

Study Record Updates

Last Update Posted (Estimated)

September 15, 2025

Last Update Submitted That Met QC Criteria

September 8, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00027998 (Other Identifier: OHSU Knight Cancer Institute)
  • NCI-2024-10661 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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