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

Summary

This phase I trial tests the safety, side effects and best dose of anti-CD19/20/22 chimeric antigen receptor (CAR) T cells (TriCAR19.20.22 T cells) and how well they work in treating patients with non-Hodgkin lymphoma, acute lymphoblastic leukemia (ALL) and chronic lymphocytic leukemia (CLL) that has come back after a period of improvement (relapsed) or that has not responded to previous treatment (refractory). CAR T-cell therapy is a type of treatment in which a patient's T cells (a type of immune system cell) are changed in the laboratory so they will attack cancer cells. T cells are taken from a patient's blood. Then the gene for a special receptor that binds to a certain protein, such as CD19, CD20 and CD22, on the patient's cancer cells is added to the T cells in the laboratory. The special receptor is called a CAR. Large numbers of the CAR T cells are grown in the laboratory and given to the patient by infusion for treatment of certain cancers. Giving TriCAR19.20.22 T cells may be safe, tolerable, and/or effective in treating patients with relapsed or refractory non-Hodgkin lymphoma, ALL and CLL.

Conditions

• Blast Phase Chronic Myeloid Leukemia, BCR-ABL1 Positive
• Recurrent Acute Lymphoblastic Leukemia
• Recurrent Chronic Lymphocytic Leukemia
• Recurrent Chronic Myeloid Leukemia, BCR-ABL1 Positive
• Recurrent Indolent Non-Hodgkin Lymphoma
• Recurrent Lymphoblastic Lymphoma
• Recurrent Non-Hodgkin Lymphoma
• Recurrent Transformed Chronic Lymphocytic Leukemia
• Refractory Acute Lymphoblastic Leukemia
• Refractory Chronic Lymphocytic Leukemia
• Refractory Chronic Myeloid Leukemia, BCR-ABL1 Positive
• Refractory Indolent Non-Hodgkin Lymphoma
• Refractory Lymphoblastic Lymphoma
• Refractory Non-Hodgkin Lymphoma
• Refractory Transformed Chronic Lymphocytic Leukemia

Interventions

BIOLOGICAL

Autologous Anti-CD19/CD20/CD22 CAR T-cells

Given IV

PROCEDURE

Biospecimen Collection

Undergo blood sample collection

PROCEDURE

Bone Marrow Aspiration

Undergo bone marrow biopsy and aspiration

PROCEDURE

Bone Marrow Biopsy

Undergo bone marrow biopsy and aspiration

PROCEDURE

Computed Tomography

Undergo PET/CT

DRUG

Cyclophosphamide

Given IV

PROCEDURE

Echocardiography Test

Undergo echocardiography

DRUG

Fludarabine

Given IV

PROCEDURE

Multigated Acquisition Scan

Undergo MUGA

PROCEDURE

Pheresis

Undergo apheresis

PROCEDURE

Positron Emission Tomography

Undergo PET/CT

Sponsors & Collaborators

• Ohio State University Comprehensive Cancer Center

  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

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-01-14

Primary Completion

2026-12-31

Completion

2026-12-31

FDA Drug

Yes

Countries

• United States

Study Locations