RecruitingPhase 1NCT05418088

Genetically Engineered Cells (Anti-CD19/CD20/CD22 CAR T-cells) for the Treatment of Relapsed or Refractory Lymphoid Malignancies

Phase I Clinical Trial of Anti-CD19/20/22 Chimeric Antigen Receptor T Cells for Treatment of Relapsed or Refractory Lymphoid Malignancies (Non-Hodgkin Lymphoma, Acute Lymphoblastic Leukemia, Chronic Lymphocytic Leukemia, B-Prolymphocytic Leukemia)


Sponsor

Sumithira Vasu

Enrollment

54 participants

Start Date

Jun 30, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

This phase I trial tests the safety, side effects and best infusion dose of genetically engineered cells called anti-CD19/CD20/CD22 chimeric antigen receptor (CAR) T-cells following a short course of chemotherapy with cyclophosphamide and fludarabine in treating patients with lymphoid cancers (malignancies) that have come back (recurrent) or do not respond to treatment (refractory). Lymphoid malignancies eligible for this trial are: non-Hodgkin lymphoma (NHL), acute lymphoblastic leukemia (ALL), chronic lymphocytic leukemia (CLL), and B-prolymphocytic leukemia (B-PLL). T-cells (a type of white blood cell) form part of the body's immune system. CAR-T is a type of cell therapy that is used with gene-based therapies. CAR T-cells are made by taking a patient's own T-cells and genetically modifying them with a virus so that they are recognized by a group of proteins called CD19/CD20/CD22 which are found on the surface of cancer cells. Anti-CD19/CD20/CD22 CAR T-cells can recognize CD19/CD20/CD22, bind to the cancer cells and kill them. Giving combination chemotherapy helps prepare the body before CAR T-cell therapy. Giving CAR-T after cyclophosphamide and fludarabine may kill more tumor cells.


Eligibility

Min Age: 2 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a type of personalized cell therapy called CAR T-cell therapy for adults with blood cancers that involve certain immune cell types (B-cell lymphomas and leukemias). The therapy engineers a patient's own immune cells to attack cancer cells that carry specific markers (CD19, CD20, or CD22). **You may be eligible if...** - You are an adult (18 or older) - You have a relapsed or treatment-resistant B-cell blood cancer, such as non-Hodgkin lymphoma, chronic lymphocytic leukemia, or B-cell acute lymphoblastic leukemia - Prior standard treatments have not worked - Your cancer has specific markers (CD19, CD20, or CD22 positive) confirmed by testing **You may NOT be eligible if...** - You have active, uncontrolled infection (including HIV or active hepatitis) - You have significant organ dysfunction (heart, liver, kidneys) - You have had a prior CAR T-cell therapy that targeted these same markers - You have active autoimmune disease requiring treatment - 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.

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Interventions

BIOLOGICALAnti-CD19/CD20/CD22 CAR T-Cells

Given IV

DRUGCyclophosphamide

Given IV

DRUGFludarabine Phosphate

Given IV

PROCEDUREEchocardiography

Undergo echocardiography

PROCEDUREMultigated Acquisition Scan

Undergo MUGA scan

PROCEDUREBiopsy

Undergo tissue biopsy

PROCEDUREPheresis

Undergo apheresis

PROCEDUREBone Marrow Aspiration and Biopsy

Undergo bone marrow aspiration and biopsy

PROCEDUREBiospecimen Collection

Undergo blood sample collection


Locations(2)

Nationwide Children's Hospital

Columbus, Ohio, United States

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States

View Full Details on ClinicalTrials.gov

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NCT05418088


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