Recruiting

CAR-T Vaccine Responses

Sponsor:

OHSU Knight Cancer Institute

Code:

NCT06784167

Conditions

Chronic Lymphocytic Leukemia

Diffuse Large B-Cell Lymphoma

Follicular Lymphoma

Mantle Cell Lymphoma

Multiple Myeloma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Non-Interventional Study

Study Details

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.

Conditions

Chronic Lymphocytic Leukemia

Diffuse Large B-Cell Lymphoma

Follicular Lymphoma

Mantle Cell Lymphoma

Multiple Myeloma

Study ID

NCT06784167

Start date

Mar 10, 2025

Status verified date

Sep, 2025

Completion date

Apr 12, 2027

Anticipated

Primary completion date

Jan 11, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

45 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Interventions

Non-Interventional Study

Non-interventional study

Primary outcome measure

  • Preserved immunity [ Time Frame: Up to 12 months after CAR-T cell infusion ]

Central Contacts and Locations

Locations

OHSU Knight Cancer Institute

Recruiting

Portland, Oregon, United States, 97239

Contacts

Amrita Desai

503-494-8534desaia@ohsu.edu

Principal Investigator:

Amrita Desai

More Information

Sponsor

OHSU Knight Cancer Institute

Last update posted

Sep 15, 2025

Last verified

Sep, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by OHSU Knight Cancer Institute on 2025-09-15.