Trials / Recruiting

RecruitingNCT07166419

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

Phase I Clinical Trial of Caring Cross 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) (C3PO)

Status: Recruiting
Phase: Phase 1
Study type: Interventional
Enrollment: 24 (estimated)

Sponsor: Ohio State University Comprehensive Cancer Center · Academic / Other
Sex: All
Age: 18 Years
Healthy volunteers: Not accepted

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.

Detailed description

PRIMARY OBJECTIVE: I. To determine the safety of the treatment of relapsed/refractory non-Hodgkin lymphoma, relapsed/refractory chronic lymphocytic leukemia, lymphoid blast crisis from chronic myeloid leukemia and relapsed/refractory acute lymphoblastic leukemia with chimeric antigen receptor T cells targeting CD19/20/22 and to find the recommended phase II dose for this cellular therapy. SECONDARY OBJECTIVES: I. To describe the safety profile of the infusion of CAR-T cells targeting CD19/20/22 in relapsed/refractory non-Hodgkin lymphoma, relapsed/refractory chronic lymphocytic leukemia, lymphoid blast crisis from chronic myeloid leukemia and in relapsed/refractory acute lymphoblastic leukemia. II. To describe the toxicities related to infusion of CAR-T cells targeting CD19/20/22. III. To describe the overall response rate and complete response rate of relapsed B cell malignancies treated with CAR-T cells targeting CD19/20/22. IV. To describe the overall and progression free survival of patients with relapsed lymphoma, CLL, and ALL treated with autologous anti-CD19/CD20/CD22 CAR T-cells (TriCAR19.20.22 T cells). CORRELATIVE OBJECTIVES: I. To describe the persistence of TriCAR19.20.22 T cells, measured by flow cytometry and quantitative polymerase chain reaction (qPCR). II. To describe the T cell subpopulations of the TriCAR19.20.22 T cell product before infusion. III. To describe the changes in TriCAR19.20.22 T cells after infusion and their correlation with disease response and adverse events. IV. To investigate the correlation between changes in cytokine plasma concentrations and changes in TriCAR19.20.22 T cell subpopulations over time. V. To investigate proteomic changes in TriCAR19.20.22 T cell subpopulations over time. VI. To investigate whether antigen escape occurs in patients treated with TriCAR19.20.22. OUTLINE: This is a dose-escalation study of TriCAR19.20.22 T cells. Patients are assigned to 1 of 2 cohorts. COHORT A: Patients undergo apheresis between days -30 and -7 or days -9 and -7. Patients receive lymphodepletion chemotherapy with cyclophosphamide intravenously (IV) on day -6, fludarabine IV over 30 minutes on days -5 to -3. Patients then receive TriCAR19.20.22 T cells IV over 5-30 minutes on day 0. Patients also undergo echocardiography or multigated acquisition scan (MUGA) at baseline and blood sample collection and bone marrow biopsy and aspiration throughout the study. Additionally, patients undergo positron emission tomography (PET)/computed tomography (CT) as clinically indicated throughout the study. COHORT B: Patients undergo apheresis between days -30 and -7 or days -9 and -7. Patients receive lymphodepletion chemotherapy with cyclophosphamide IV on day -6, fludarabine IV over 30 minutes on days -5 to -3 and TriCAR19.20.22 T cells IV over 5-30 minutes on days 0 and 7. Patients also undergo echocardiography or MUGA at baseline and blood sample collection and bone marrow biopsy and aspiration throughout the study. Additionally, patients undergo PET/CT as clinically indicated throughout the study. After completion of study treatment, patients are followed for up at 7, 14, 21, 30, 60, and 90 days, at 6 and 12 months, then yearly for up to year 15.

Conditions

Interventions

Type	Name	Description
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

Timeline

Start date: 2026-01-14
Primary completion: 2026-12-31
Completion: 2026-12-31
First posted: 2025-09-10
Last updated: 2026-04-15

Locations

1 site across 1 country: United States

Regulatory

FDA-regulated drug study

Source: ClinicalTrials.gov record NCT07166419. Inclusion in this directory is not an endorsement.