RecruitingPhase 2NCT05260957

CAR-T Cell Therapy, Mosunetuzumab and Polatuzumab for Treatment of Refractory/Relapsed Aggressive Non-Hodgkin's Lymphoma (NHL).

ML43165 - Single Arm Phase 2 Trial of an FDA Approved Anti-CD19 CAR-T Therapy Followed by Mosunetuzumab and Polatuzumab Consolidation for the Treatment of Refractory/Relapsed Aggressive NHL.

Sponsor

Lazaros Lekakis

Enrollment

22 participants

Start Date

Dec 14, 2022

Study Type

INTERVENTIONAL

Conditions

Refractory Non-Hodgkin Lymphoma Relapsed Non Hodgkin Lymphoma Aggressive Non-Hodgkin Lymphoma

Summary

The purpose of this research study is to test if a combination treatment of chimeric antigen receptor (CAR) T-cell therapy, Mosunetuzumab, and Polatuzumab Vedotin will result in tumor reduction.

Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of CAR-T cell therapy (a type of personalized immune cell treatment), mosunetuzumab, and polatuzumab for people with aggressive B-cell lymphoma that has returned or stopped responding to previous treatments. **You may be eligible if...** - You have been diagnosed with diffuse large B-cell lymphoma (DLBCL), primary mediastinal B-cell lymphoma, or transformed follicular lymphoma - Your lymphoma has relapsed or not responded to prior treatment - Your cancer expresses a protein called CD19 - Your insurance approves CAR-T therapy - You are in adequate health to undergo this intensive treatment **You may NOT be eligible if...** - You have lymphoma arising after an organ transplant (post-transplant lymphoproliferative disorder) - Your cancer does not express CD19 - You have uncontrolled infections or serious organ problems - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGMosunetuzumab

Induction Phase (Days -42 through -7): * 1 mg of Mosunetuzumab administered via intravenous (IV) infusion (given as per treatment guidelines) on Day -42. * 2 mg of Mosunetuzumab administered via intravenous (IV) infusion (given as per treatment guidelines) on Day -35. * 60 mg of Mosunetuzumab administered via intravenous (IV) infusion on (given as per treatment guidelines) on Days -28 and -7. Consolidation Phase (Day +1 through Day +90): 30 mg IV Mosunetuzumab administered via intravenous (IV) infusion (given as per treatment guidelines) on Days +14, +35, +56 and +77.

DRUGPolatuzumab

Induction Phase (Days -42 through -7): 1.8mg/kg of Polatuzumab administered via intravenous (IV) infusion (given as per treatment guidelines) on Day -28. Consolidation Phase (Days +1 through +90): 1.8mg/kg of Polatuzumab administered via intravenous (IV) infusion (given as per treatment guidelines) on Days +35, +56 and +77.

BIOLOGICALCAR-T Cell Therapy

Participants will receive CAR-T Cell therapy via infusion on Day 0 (given as per treatment guidelines). Prior to CAR-T Cell Therapy, participants will begin receiving lymphodepleting chemotherapy on Days -5 through -3 (given as per treatment guidelines).

Locations(1)

University of Miami

Miami, Florida, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05260957

Related Trials

Anti-CD19/20/22 Chimeric Antigen Receptor T Cells (TriCAR19.20.22 T Cells) for the Treatment of Relapsed or Refractory Non-Hodgkin Lymphoma, Acute Lymphoblastic Leukemia, and Chronic Lymphocytic Leukemia

NCT071664191 location

Immune Cell Therapy (CAR-T) for the Treatment of Patients With HIV and B-Cell Non-Hodgkin Lymphoma

NCT050775276 locations

Polatuzumab Vedotin and Combination Chemotherapy With or Without Glofitamab for the Treatment of Untreated Aggressive Large B-cell Lymphoma

NCT042318771 location

Tegavivint for the Treatment of Recurrent or Refractory Solid Tumors, Including Lymphomas and Desmoid Tumors

NCT0485111921 locations

Anti-CD19, Dual Co-stimulatory (4-1BB, CD3ζ) Chimeric Antigen Receptor T-cells in Patients With Relapsed/Refractory Aggressive Lymphoma or Acute Lymphoblastic Leukemia (ALL)

NCT039389876 locations