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CAR T-cell Therapy

CAR T-cell Therapy for Non-Hodgkin Lymphoma

Phase 1

Recruiting

Led By Matthew Frigault, MD

Research Sponsored by Marcela V. Maus, M.D.,Ph.D.

Eligibility Criteria Checklist

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

Must have

≥18 years of age at the time of signing informed consent

- Diffuse large B-cell lymphoma (DLBCL), including transformed follicular lymphoma (FL), primary mediastinal B-cell lymphoma (PMBCL), high-grade B-cell lymphoma (HGBCL) and grade 3b Follicular Lymphoma (FL). - R/R disease after 2 or more prior lines of therapy OR - Relapsed following autologous SCT, OR - Ineligible for autologous SCT.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from day 0 to 2 years post-treatment

Awards & highlights

Study Summary

This trial studies the use of CAR T cells to treat people with advanced Non-Hodgkin Lymphoma that has relapsed or not responded to treatment.

Who is the study for?

This trial is for adults over 18 with certain types of Non-Hodgkin Lymphoma that have relapsed or are not responding to treatment. They must have had specific prior therapies, be in a stable condition without severe infections or heart problems, and not be pregnant. Participants should also agree to use contraception.Check my eligibility

What is being tested?

The study tests CD79b-19 CAR T cells in patients with Non-Hodgkin Lymphoma who haven't responded well to other treatments. It includes standard chemotherapy drugs cyclophosphamide and fludarabine used in the lymphodepleting process before administering the CAR T cells.See study design

What are the potential side effects?

Possible side effects include immune system reactions, fever, fatigue, difficulty breathing, changes in blood pressure or heart rate during infusion; there may also be risks related to chemotherapy such as nausea and low blood cell counts.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I have a specific type of lymphoma and it has returned or not responded after at least 2 treatments.

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I am mostly self-sufficient and can carry out daily activities.

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My Marginal Zone Lymphoma has not improved after at least 2 treatments.

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My follicular lymphoma has returned or resisted treatment after 2+ therapies.

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My condition is relapsed or refractory mantle cell lymphoma.

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I have been treated with anthracycline or bendamustine, anti-CD20 therapy, and BTKi therapy.

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My kidneys work well, with a creatinine clearance over 60 ml/min.

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My liver tests are within normal limits.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from day 0 to 2 years post-treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from day 0 to 2 years post-treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and from day 0 to 2 years post-treatment for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Incidence of Dose Limiting Toxicity (DLT)

Incidence of adverse events (AEs)

Secondary outcome measures

Overall Response Rate (ORR)

Overall Survival (OS)

Progression Free Survival (PFS)

Trial Design

1Treatment groups

Experimental Treatment

Group I: CD79b-19 CAR T cellsExperimental Treatment3 Interventions

Prior to receiving CD79b-19 CAR T cells, participants will undergo two preparatory processes: Leukapheresis: During Week -3 white blood cells will be collected. Lymphodepletion: On days, -5 to -3 participants will receive 3 days of chemotherapy to decrease the number of lymphocytes CD79b-19 CAR T cells will be administered intravenously on day 0 only. The dose you will receive will depend on the number of participants who have been enrolled prior and how well the dose was tolerated. The CD79b-19 CAR T cells will be administered over approximately 1 hour.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cyclophosphamide

1995

Completed Phase 3

~3770

Fludarabine

2012

Completed Phase 3

~1100

0 / 9Eligibility criteria met

Find a Location

Who is running the clinical trial?

Marcela V. Maus, M.D.,Ph.D.Lead Sponsor

4 Previous Clinical Trials

60 Total Patients Enrolled

Matthew Frigault, MDPrincipal InvestigatorMassachusetts General Hospital

Frequently Asked Questions

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

What potential risks could be associated with CD79b-19 CAR T cells?

"Due to the lack of prior data concerning CD79b-19 CAR T cells, Power's team assigned it a score of 1. This is standard practice for Phase 1 trials as they are focused on establishing safety and efficacy."

Answered by AI

Are there still openings available to participate in the study?

"According to clinicaltrials.gov, this trial is no longer interested in recruiting patients. Initially posted on February 1st 2024 and lastly updated on September 6th 2023, there are 1827 other trials currently seeking applicants at the present moment."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

CD79b-19 CAR T Cells in Non-Hodgkin Lymphoma

Marcela V. Maus, M.D.,Ph.D. 2023. "CD79b-19 CAR T Cells in Non-Hodgkin Lymphoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06026319.

All > Marginal Zone Lymphoma