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CAR T-cell Therapy

PCV13 + CAR T-Cell Therapy for Lymphoma

Phase 2

Recruiting

Led By Frederick Locke, MD

Research Sponsored by H. Lee Moffitt Cancer Center and Research Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at 90 days and 180 days post car t therapy

Awards & highlights

Study Summary

This trial will test whether receiving the pneumococcal 13-valent conjugate vaccine before and after CD19-targeted CAR T cell therapy will help to create immunity against pneumococcus.

Who is the study for?

This trial is for adults over 18 with certain types of B-cell lymphoma who are in good health or have relapsed/refractory disease and are candidates for CD19-targeted CAR T cell therapy. They must be willing to use effective contraception if applicable, and cannot participate if they have severe allergies to vaccines, active infections, very low blood counts, recent IVIG treatment, or are pregnant.Check my eligibility

What is being tested?

The study tests whether the pneumococcal conjugate vaccine (PCV13) given before and after CD19-targeted CAR T cell therapy can improve immune response against pneumococcus in patients with specific types of B-cell lymphoma.See study design

What are the potential side effects?

Potential side effects from PCV13 include pain at the injection site, fatigue, headache, muscle pain, joint pain, decreased appetite. The CAR T cell therapy may cause flu-like symptoms, difficulty breathing due to inflammation in lungs or other organs.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 90 days and 180 days post car t therapy

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at 90 days and 180 days post car t therapy

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 90 days and 180 days post car t therapy for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Humoral Response Rate -PCV13 vaccine

Secondary outcome measures

Increase in On-Specific Serotype IgG levels

Serotyping

Overall Survival

+2 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: TreatmentExperimental Treatment2 Interventions

Pneumococcal conjugate vaccine (PCV13) .5 ml will be administered intramuscularly three times: 7 days (range 4 to 21 days) before apheresis collection and on day +30 (range +21 to +37) and day +90 (range +75 to +115) after CAR T cell infusion.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

H. Lee Moffitt Cancer Center and Research InstituteLead Sponsor

543 Previous Clinical Trials

135,469 Total Patients Enrolled

Frederick Locke, MDPrincipal InvestigatorMoffitt Cancer Center

Media Library

CD19 targeted CAR T Cell Therapy (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04745559 — Phase 2

B-Cell Lymphoma Research Study Groups: Treatment

B-Cell Lymphoma Clinical Trial 2023: CD19 targeted CAR T Cell Therapy Highlights & Side Effects. Trial Name: NCT04745559 — Phase 2

CD19 targeted CAR T Cell Therapy (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04745559 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any openings still available for this clinical trial?

"According to the information hosted on clinicaltrials.gov, this medical research is actively recruiting at present. The trial was posted on February 18th 2021 and had its most recent update by November 10th 2022."

Answered by AI

What is the current patient participation in this clinical experiment?

"Affirmative. According to the clinicaltrials.gov registry, this medical experiment is actively recruiting participants. It was initially made public on February 18th 2021 and had its last update on November 10th 2022; 26 people must be enrolled from a single location for it to proceed."

Answered by AI

Has CD19 targeted CAR T Cell Therapy received regulatory clearance?

"CAR T cell therapy is relatively new, and hence has not been tested for efficacy yet. However, given the existing safety data available it was rated as a 2 on our 1-3 scale at Power."

Answered by AI

Are there antecedent experiments involving CD19-oriented CAR T Cell Therapy?

"Currently, 21 trials for CD19 targeted CAR T Cell Therapy are underway with 5 of them in their terminal phase. Jamaica, New york is a major hub for this medical intervention; however there are 321 different sites conducting research on it throughout the world."

Answered by AI

What health ailments is CD19 targeted CAR T Cell Therapy regularly used to address?

"When treating tetanus, CD19 targeted CAR T Cell Therapy has proven to be effective. Additionally, this same therapy can treat traumatic injuries, pneumococcal infections and diphtheria too."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Optimizing Cellular and Humoral Immunity by Vaccinating With PCV13 Before and After CAR-T Therapy

2021. "Optimizing Cellular and Humoral Immunity by Vaccinating With PCV13 Before and After CAR-T Therapy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04745559.