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

NCT07166419 | Recruiting Phase 1 DMC FDA Drug

• 2 other identifiers: OSU-24176NCI-2025-05721
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (2)

• Dose-limiting toxicity

  Adverse events will be graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5.0 with the exception of cytokine release syndrome (CRS). CRS will be graded according to the American Society for Transplantation and Cellular Therapy (ASTCT) Consensus Grading for CRS.

  Up to 30 days after infusion

• Recommended phase 2 dose

  Up to 30 days after infusion

Secondary Outcomes (5)

• Incidence of adverse events (AEs)

  Up to 30 days after infusion

• Overall response rate

  Up to 15 years

• Complete response rate

  Up to 15 years

• Overall survival

  Up to 15 years

• Progression-free survival

  From entry onto study until lymphoma progression or death from any cause, assessed up to 15 years

Study Arms (2)

Cohort A (TriCAR19.20.22 T cells)

EXPERIMENTAL

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. Patients then receive TriCAR19.20.22 T cells IV over 5-30 minutes on day 0. Patients also undergo echocardiography or MUGA at baseline and blood sample collection and bone marrow biopsy and aspiration throughout the study. Additionally, patients undergo positron emission tomography PET/CT as clinically indicated throughout the study.

Biological: Autologous Anti-CD19/CD20/CD22 CAR T-cells; Procedure: Biospecimen Collection; Procedure: Bone Marrow Aspiration; Procedure: Bone Marrow Biopsy; Procedure: Computed Tomography; Drug: Cyclophosphamide; Procedure: Echocardiography Test; Drug: Fludarabine; Procedure: Multigated Acquisition Scan; Procedure: Pheresis; Procedure: Positron Emission Tomography

Cohort B (TriCAR19.20.22 T cells)

EXPERIMENTAL

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.

Biological: Autologous Anti-CD19/CD20/CD22 CAR T-cells; Procedure: Biospecimen Collection; Procedure: Bone Marrow Aspiration; Procedure: Bone Marrow Biopsy; Procedure: Computed Tomography; Drug: Cyclophosphamide; Procedure: Echocardiography Test; Drug: Fludarabine; Procedure: Multigated Acquisition Scan; Procedure: Pheresis; Procedure: Positron Emission Tomography

Interventions

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

Given IV

Also known as: Autologous Anti-CD19/CD20/CD22 CAR T Cells, Autologous Anti-CD19/CD20/CD22 CAR-T Cells, Autologous CAR19.20.22 CAR T-cells

Cohort A (TriCAR19.20.22 T cells); Cohort B (TriCAR19.20.22 T cells)

Biospecimen Collection PROCEDURE

Undergo blood sample collection

Also known as: Biological Sample Collection, Biospecimen Collected, Specimen Collection

Cohort A (TriCAR19.20.22 T cells); Cohort B (TriCAR19.20.22 T cells)

Bone Marrow Aspiration PROCEDURE

Undergo bone marrow biopsy and aspiration

Cohort A (TriCAR19.20.22 T cells); Cohort B (TriCAR19.20.22 T cells)

Bone Marrow Biopsy PROCEDURE

Undergo bone marrow biopsy and aspiration

Also known as: Biopsy of Bone Marrow, Biopsy, Bone Marrow

Cohort A (TriCAR19.20.22 T cells); Cohort B (TriCAR19.20.22 T cells)

Computed Tomography PROCEDURE

Undergo PET/CT

Also known as: CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography, Computerized axial tomography (procedure), Computerized Tomography, Computerized Tomography (CT) scan, CT, CT Scan, tomography

Cohort A (TriCAR19.20.22 T cells); Cohort B (TriCAR19.20.22 T cells)

Cyclophosphamide DRUG

Given IV

Also known as: (-)-Cyclophosphamide, 2H-1,3,2-Oxazaphosphorine, 2-[bis(2-chloroethyl)amino]tetrahydro-, 2-oxide, monohydrate, Asta B 518, B 518, B-518, B518, Carloxan, Ciclofosfamida, Ciclofosfamide, Cicloxal, Clafen, Claphene, CP monohydrate, CTX, CYCLO-cell, Cycloblastin, Cycloblastine, Cyclophospham, Cyclophosphamid monohydrate, Cyclophosphamide Monohydrate, Cyclophosphamidum, Cyclophosphan, Cyclophosphane, Cyclophosphanum, Cyclostin, Cyclostine, Cytophosphan, Cytophosphane, Cytoxan, Fosfaseron, Genoxal, Genuxal, Ledoxina, Mitoxan, Neosar, Revimmune, Syklofosfamid, WR 138719, WR- 138719, WR-138719, WR138719

Cohort A (TriCAR19.20.22 T cells); Cohort B (TriCAR19.20.22 T cells)

Echocardiography Test PROCEDURE

Undergo echocardiography

Also known as: EC, Echocardiography

Cohort A (TriCAR19.20.22 T cells); Cohort B (TriCAR19.20.22 T cells)

Fludarabine DRUG

Given IV

Also known as: Fluradosa

Cohort A (TriCAR19.20.22 T cells); Cohort B (TriCAR19.20.22 T cells)

Multigated Acquisition Scan PROCEDURE

Undergo MUGA

Also known as: Blood Pool Scan, Equilibrium Radionuclide Angiography, Gated Blood Pool Imaging, Gated Heart Pool Scan, MUGA, MUGA Scan, Multi-Gated Acquisition Scan, Radionuclide Ventriculogram Scan, Radionuclide Ventriculography, RNV Scan, RNVG, SYMA Scanning, Synchronized Multigated Acquisition Scanning

Cohort A (TriCAR19.20.22 T cells); Cohort B (TriCAR19.20.22 T cells)

Pheresis PROCEDURE

Undergo apheresis

Also known as: Apheresed, Apheresis, Blood Component Removal, Collection, Apheresis/Leukapheresis, Hemapheresis

Cohort A (TriCAR19.20.22 T cells); Cohort B (TriCAR19.20.22 T cells)

Positron Emission Tomography PROCEDURE

Undergo PET/CT

Also known as: Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure), Positron Emission Tomography Scan, Positron-Emission Tomography, PT

Cohort A (TriCAR19.20.22 T cells); Cohort B (TriCAR19.20.22 T cells)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• COHORT A: Subjects must have relapsed or refractory non-Hodgkin lymphoma with lesions ≤ 5 cm, indolent lymphomas, or chronic lymphocytic leukemia without Richter's transformation
• COHORT B: Subjects with lymphoid blast crisis from chronic myeloid leukemia, acute lymphoblastic leukemia, chronic lymphocytic leukemia with Richter's transformation, non-Hodgkin lymphoma with lesions \> 5 cm and/or lymphoblastic lymphoma, or non-Hodgkin lymphoma with circulating lymphoma cells
• Subjects must have been treated with at least two lines of therapy; subjects with prior commercial or investigational CAR T therapy targeting CD19, and/or CD20, and/or CD22 are permitted. Disease must have either progressed after the last regimen or presented failure to achieve complete remission with the last regimen
• Note: Cohort assignment at discretion of principal investigator (PI) depending on patient disease/ history
• Subjects with relapsed/refractory CLL after at least 2 prior lines of appropriate therapy and must have previously received an approved Bruton's tyrosine kinase (BTK) inhibitor and venetoclax
• In subjects who had a prior autologous stem cell transplant for refractory high-grade B-cell lymphoma who relapse within 12 months of autologous stem cell transplant are eligible
• Subjects with relapsed/refractory acute B-lymphoblastic leukemia who received at least 2 prior lines of appropriate therapy. Subjects are also eligible if they have failed or are ineligible for allogeneic stem cell transplant
• Subjects with relapsed/refractory lymphoid blast crisis from prior chronic myeloid leukemia (CML) who received at least 2 prior lines of therapy (tyrosine kinase inhibitors, multiagent chemotherapy) or have failed or are ineligible for allogeneic stem cell transplant
• The patient's lymphoid malignancy must be positive for CD19 and/or CD20 and/or CD22, either by immunohistochemistry or flow cytometry analysis on the last biopsy available or peripheral blood for circulating disease
• Subjects with prior commercial or investigational CAR T therapy targeting CD19, and/or CD20, and/or CD22 are permitted if it has been at least 30 days since previous CAR T cell therapy and \< 5% of circulating levels of CD3+ cells express the prior CAR by flow cytometry
• Subjects who received antibodies targeting CD19, or CD20, or CD22 are eligible
• Age ≥ 18 years
• Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
• Total bilirubin ≤ 1.5 times the institutional upper limit of normal
• Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\]) ≥ 3 x institutional upper limit of normal

You may not qualify if:

• Autologous transplant within 6 weeks of planned CAR-T cell infusion
• Allogeneic stem cell transplant or donor lymphocyte infusion within 2 months of planned CAR-T cell infusion and patients must be off immunosuppressive agents
• Subjects with live vaccines given 28 days prior to lymphodepleting (LD) chemotherapy will be excluded
• Active graft versus host disease
• Active malignancy, other than non-melanoma skin cancer or carcinoma in situ (e.g. cervix, bladder, breast). Subjects with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial (e.g. low Gleason score prostate cancer)
• A minimum of 28 days must have elapsed between prior treatment with investigational agent(s) and the day of lymphocyte collection
• HIV-seropositive patients are allowable, however must be on effective anti-retroviral therapy with undetectable viral load within 6 months of enrollment to be eligible for this trial
• Subjects with uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, pulmonary abnormalities or psychiatric illness/social situations that would limit compliance with study requirements
• Pregnant or breastfeeding women are excluded from this study because CAR-T cell therapy may be associated with the potential for teratogenic or abortifacient effects. Women of childbearing potential must have a negative serum pregnancy test. Because there is an unknown, but potential risk for adverse events in nursing infants secondary to treatment of the mother with CAR-T cells, breastfeeding should be discontinued. These potential risks may also apply to other agents used in this study
• Evidence of myelodysplasia or cytogenetic abnormality indicative of myelodysplasia on any bone marrow biopsy prior to initiation of therapy
• Subjects with a positive hepatitis B core antibody or surface antigen are at high risk for hepatitis B virus (HBV) reaction and will require entecavir/tenofivir prophylaxis or serial hepatitis B (Hep) B polymerase chain reaction (PCR) monitoring at the direction of an infectious disease specialist. Duration of prophylaxis to correspond with detection of TriCAR19.20.22 T cells/viral vector copies in serum or continued evidence of B-cell aplasia such as reduced intravenous immunoglobulin (IVIG) levels. No antiviral prophylaxis is indicated with hepatitis C positivity with negative PCR
• Subjects with history of clinically relevant CNS pathology such as epilepsy, seizure disorders, paresis, aphasia, uncontrolled cerebrovascular disease, severe brain injuries, dementia and Parkinson's disease
• History of autoimmune disease (i.e. rheumatoid arthritis, systemic lupus erythematosus) with requirement of immunosuppressive medication within 6 months

Sponsors & Collaborators

• Ohio State University Comprehensive Cancer Center: lead

Study Sites (1)

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

RECRUITING

Related Links

• The Jamesline

MeSH Terms

Conditions

Blast Crisis; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphocytic, Chronic, B-Cell; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Lymphoma, Non-Hodgkin

Interventions

Specimen Handling; Biopsy; Cyclophosphamide; fludarabine; Blood Component Removal; Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Cell Transformation, Neoplastic; Carcinogenesis; Neoplastic Processes; Myeloproliferative Disorders; Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Leukemia, Lymphoid; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Leukemia, B-Cell; Lymphoma

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Cytodiagnosis; Cytological Techniques; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Therapeutics; Spectrum Analysis; Chemistry Techniques, Analytical

Study Officials

• Sumithira Vasu, MD

  Ohio State University Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

The Ohio State University Comprehensive Cancer Center

CONTACT

800-293-5066; OSUCCCClinicaltrials@osumc.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 3, 2025
• First Posted: September 10, 2025
• Study Start: January 14, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 15, 2026

Record last verified: 2026-03

Locations

US (1)