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

Recruiting

• Conditions: Chronic Lymphocytic Leukemia; Diffuse Large B-Cell Lymphoma; Follicular Lymphoma; Mantle Cell Lymphoma; Multiple Myeloma; Primary Mediastinal Large B-Cell Lymphoma; Small Lymphocytic Lymphoma

• Registration Number: NCT06784167
• Lead Sponsor: OHSU Knight Cancer Institute

Brief 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.

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 Timeline

• Study First Submitted: 2025-01-14
• Study First Submitted QC: 2025-01-14
• Study First Posted: 2025-01-20
• Status Verified: 2025-03
• Study Start: 2025-03-10
• Last Update Submitted: 2025-03-17
• Last Update Posted: 2025-03-20
• Primary Completion: 2027-01-11
• Study Completion: 2027-04-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 45

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Preserved immunity	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.

Secondary Outcome Measures

Name	Time	Method
Change in antibody titers	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.

Trial Locations

Locations (1)

OHSU Knight Cancer Institute; 🇺🇸 Portland, Oregon, United States