Neoplasms

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Infections

Symptoms and General Pathology

Rare Diseases

Lymphoma

Lymphoma, Mantle-Cell

Lymphoma, Follicular

Lymphoma, B-Cell, Marginal Zone

Lymphoma, Large B-Cell, Diffuse

Lymphoma, B-Cell

Burkitt Lymphoma

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphoma, Non-Hodgkin

Communicable Diseases

Epstein-Barr Virus Infections

Virus Diseases

Herpesviridae Infections

DNA Virus Infections

Tumor Virus Infections

Lymphosarcoma

Mantle Cell Lymphoma

Follicular Lymphoma

B-cell Lymphoma

Marginal Zone Lymphoma

Diffuse Large B-Cell Lymphoma

All Drugs and Chemicals

Amino Acids

Pirtobrutinib

Tyrosine Kinase Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Tyrosine

Pirtobrutinib is an oral agent. LV20.19 CAR T cells will be administered either fresh or thawed after cryopreservation by IV injection.

Pirtobrutinib will be administered at 200 mg/day orally starting at least 14 days prior to apheresis as bridging until the start of lymphodepletion and restarted between day 28-120 for up to one year as maintenance post cell infusion.

Subjects will receive a dose of 2.5x10\^6 CAR-T cells/kg as a previously identified safe in a Phase 1 protocol at the Medical College of Wisconsin.

LV20.19 CAR T cells

Medical College of Wisconsin Cancer Center Clinical Trials Office

Nirav Shah, MD

This is a phase I, interventional, single arm, open label, treatment study designed to evaluate the safety and efficacy of LV20.19 CAR -T cells with pirtobrutinib bridging and maintenance in adult patients with B cell malignancies that have failed prior therapies.

This is the first study to evaluate the safety and impact of the combination of pirtobrutinib and LV20.19 CAR-T cells.

Pirtobrutinib is a first-in-class non-covalent Bruton's tyrosine kinase (BTK) inhibitor. The safe dose of this agent has been identified the BRUIN study as 200 mg daily administered as an oral agent. As a single agent, the toxicity profile has been favorable and does not overlap with other covalent BTK inhibitors with minimal cardiotoxicity and bleeding complications.

LV20.19 CAR T-Cells in Combination With Pirtobrutinib for Relapsed, Refractory B-cell Malignancies

Phase I Study of LV20.19 CAR T-cells in Combination With Pirtobrutinib for Relapsed, Refractory B-cell Malignancies

This measure is the number of adverse events with grade 3 to 5 severity per Common Terminology Criteria for Adverse Events (ver. 5) occurring during the first 28 days following infusion.

Pirtobrutinib will be administered at 200 mg/day orally starting at least 14 days prior to apheresis as bridging until the start of lymphodepletion. This measure is the number of adverse events with grade 3 to 5 severity per Common Terminology Criteria for Adverse Events (ver. 5).

Pirtobrutinib will be started again at 200 mg/day orally on day 28-120 for up to one year as maintenance post cell infusion. This measure is the number of adverse events with grade 3 to 5 severity per Common Terminology Criteria for Adverse Events (ver. 5).

Medical College of Wisconsin

Associate Professor

Heart and Blood Diseases

Multiple Myeloma

Neoplasms, Plasma Cell

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hematologic Diseases

Hemorrhagic Disorders

Belantamab mafodotin is an intravenous drug.

Belantamab mafodotin will be administered IV over approximately 30 minutes at the recommended dose of 2.5 mg/kg IV over 30 minutes on day 1 of every eight-week (+/- three days) cycle for a maximum of 12 cycles. Maintenance therapy with belantamab mafodotin will continue until progressive disease (PD), death, unacceptable toxicity, withdrawal of consent or end of study (maximum of 12 cycles), whichever occurs first.

Belantamab mafodotin

Meera Mohan, MD, MS

This is a multicenter phase II, open-label study evaluating the efficacy and safety of belantamab mafodotin maintenance in participants with relapsed and/or refractory multiple myeloma (RRMM) who have received commercially available anti-BCMA CAR-T-cell therapy. Subjects will be enrolled 60-130 days after chimeric antigen receptor T-cell therapy (CAR-T) and receive belantamab mafodotin as maintenance therapy. Each maintenance cycle will have a duration of 56 days (+/- three days) and belantamab mafodotin will be administered at a dose of 2.5 mg/kg IV on day 1 of each cycle.

INTERVENTION DESCRIPTION:

Subjects will receive belantamab mafodotin as maintenance therapy. Belantamab mafodotin will be administered IV over approximately 30 minutes at the recommended dose of 2.5 mg/kg IV over 30 minutes on day 1 of every eight-week (+/- three days) cycle for a maximum of 12 cycles. Maintenance therapy with belantamab mafodotin will continue until progressive disease (PD), death, unacceptable toxicity, withdrawal of consent or end of study (maximum of 12 cycles), whichever occurs first. Dose interruptions or reductions may be required to address potential drug-associated toxicities. The dose to be administered will be based on actual body weight calculated at baseline. However, if the change in body weight is greater than 10%, the dose will be recalculated based on the actual body weight at the time of dosing. The dose may be reduced to address toxicity.

Maintenance Belantamab Mafodotin (Blenrep®) After B-cell Maturation Antigen-Directed Chimeric Antigen Receptor T-cell Therapy in Patients With Relapsed and/or Refractory Multiple Myeloma

A Multicenter Phase II Study of Maintenance Belantamab Mafodotin (Blenrep®) After BCMA-Directed Chimeric Antigen Receptor T-cell Therapy in Patients With Relapsed and/or Refractory Multiple Myeloma

The primary endpoint of the study is the 12-month progression-free survival (PFS) with time counted from the CAR-T infusion conditional on being alive and progression-free at day +90 post CAR-T. An event will be defined as documented progression or death for any cause, subjects without an event will be censored at the last date known to be alive without progression.

The number of subjects alive at the completion of the study. In long-term follow-up, subjects will be evaluated every six months.

Assistant Professor

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
LV20.19 CAR T-Cells in Combination With Pirtobrutinib for Relapsed, Refractory B-cell Malignancies	NCT05990465	Non Hodgkin Lym... Diffuse Large B... Follicular Lymp... Marginal Zone L... Mantle Cell Lym... Burkitt Lymphom...	Pirtobrutinib LV20.19 CAR T c...	18 Years - 81 Years	Medical College of Wisconsin
Maintenance Belantamab Mafodotin (Blenrep®) After B-cell Maturation Antigen-Directed Chimeric Antigen Receptor T-cell Therapy in Patients With Relapsed and/or Refractory Multiple Myeloma	NCT05117008	Refractory Mult... Relapse Multipl...	Belantamab mafo...	18 Years -	Medical College of Wisconsin

Spots Global Cancer Trial Database for car therapy

Every month we try and update this database with for car therapy cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for car therapy

Every month we try and update this database with for car therapy cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for car therapy cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.