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

Last updated: March 17, 2025
Sponsor: OHSU Knight Cancer Institute
Overall Status: Active - Recruiting

Phase

N/A

Condition

Lymphoma, B-cell

Lymphoma

Cancer/tumors

Treatment

Non-Interventional Study

Clinical Study ID

NCT06784167
STUDY00027998
STUDY00027998
NCI-2024-10661
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

    • Willingness to provide written informed consent before any study-specificprocedures or activities are performed

  • Age ≥ 18 years of age, at the time of consent

  • Documented, histologically or cytologically confirmed diagnosis of multiplemyeloma (MM), diffuse large B cell lymphoma (DLBCL),follicular lymphoma (FL),mantle cell lymphoma (MCL), chronic lymphocytic leukemia (CLL), or smalllymphocytic lymphoma (SLL), or primary mediastinal B cell lymphoma (PMBL). Allnumber of prior lines of therapy are allowed

  • History of prior vaccination against common VPD

  • Approved by managing physician for CAR-T therapy, with preparative conditioningplanned within the next 90 days

  • Approved by managing physician for revaccination against Streptococcuspneumoniae or tetanus

Exclusion

Exclusion Criteria:

    • Ongoing use of immunosuppressive agents or plans for immunosuppressive therapythat would interfere with interpretation of study endpoints

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

Study Design

Total Participants: 45
Treatment Group(s): 1
Primary Treatment: Non-Interventional Study
Phase:
Study Start date:
March 10, 2025
Estimated Completion Date:
April 12, 2027

Study 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.

Connect with a study center

  • OHSU Knight Cancer Institute

    Portland, Oregon 97239
    United States

    Active - Recruiting

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