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

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.

Conditions

• Recurrent Acute Lymphoblastic Leukemia
• Recurrent B Acute Lymphoblastic Leukemia
• Recurrent B-Cell Prolymphocytic Leukemia
• Recurrent Chronic Lymphocytic Leukemia
• Recurrent High Grade B-Cell Lymphoma
• Recurrent Indolent Non-Hodgkin Lymphoma
• Recurrent Non-Hodgkin Lymphoma
• Recurrent Transformed Chronic Lymphocytic Leukemia
• Refractory Acute Lymphoblastic Leukemia
• Refractory B Acute Lymphoblastic Leukemia
• Refractory B-Cell Prolymphocytic Leukemia
• Refractory Chronic Lymphocytic Leukemia
• Refractory High Grade B-Cell Lymphoma
• Refractory Indolent Non-Hodgkin Lymphoma
• Refractory Non-Hodgkin Lymphoma
• Refractory Transformed Chronic Lymphocytic Leukemia
• Refactory Childhood Acute Lymphoblastic Leukemia
• Refractory Childhood Non-Hodgkin Lymphoma

Interventions

BIOLOGICAL

Anti-CD19/CD20/CD22 CAR T-Cells

Given IV

DRUG

Cyclophosphamide

Given IV

DRUG

Fludarabine Phosphate

Given IV

PROCEDURE

Echocardiography

Undergo echocardiography

PROCEDURE

Multigated Acquisition Scan

Undergo MUGA scan

PROCEDURE

Biopsy

Undergo tissue biopsy

PROCEDURE

Pheresis

Undergo apheresis

PROCEDURE

Bone Marrow Aspiration and Biopsy

Undergo bone marrow aspiration and biopsy

PROCEDURE

Biospecimen Collection

Undergo blood sample collection

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• Sumithira Vasu

  lead OTHER

Principal Investigators

• Sumithira Vasu, MD · Ohio State University Comprehensive Cancer Center

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

2 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-06-30

Primary Completion

2026-07-01

Completion

2027-07-01

FDA Drug

Yes

Countries

• United States

Study Locations