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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

ConditionsBlast Phase Chronic Myeloid Leukemia, BCR-ABL1 PositiveRecurrent Acute Lymphoblastic LeukemiaRecurrent Chronic Lymphocytic LeukemiaRecurrent Chronic Myeloid Leukemia, BCR-ABL1 PositiveRecurrent Indolent Non-Hodgkin LymphomaRecurrent Lymphoblastic LymphomaRecurrent Non-Hodgkin LymphomaRecurrent Transformed Chronic Lymphocytic LeukemiaRefractory Acute Lymphoblastic LeukemiaRefractory Chronic Lymphocytic LeukemiaRefractory Chronic Myeloid Leukemia, BCR-ABL1 PositiveRefractory Indolent Non-Hodgkin LymphomaRefractory Lymphoblastic LymphomaRefractory Non-Hodgkin LymphomaRefractory Transformed Chronic Lymphocytic Leukemia
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorOhio State University Comprehensive Cancer Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

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

    Biological/Vaccine

    Given IV

  • Biospecimen Collection

    Procedure/Surgery

    Undergo blood sample collection

  • Bone Marrow Aspiration

    Procedure/Surgery

    Undergo bone marrow biopsy and aspiration

  • Bone Marrow Biopsy

    Procedure/Surgery

    Undergo bone marrow biopsy and aspiration

  • Computed Tomography

    Procedure/Surgery

    Undergo PET/CT

  • Cyclophosphamide

    Drug

    Given IV

  • Echocardiography Test

    Procedure/Surgery

    Undergo echocardiography

  • Fludarabine

    Drug

    Given IV

  • Multigated Acquisition Scan

    Procedure/Surgery

    Undergo MUGA

  • Pheresis

    Procedure/Surgery

    Undergo apheresis

  • Positron Emission Tomography

    Procedure/Surgery

    Undergo PET/CT

Treatment groups

24 Participants
are divided into 2 treatment groups
Group A: Cohort A (TriCAR19.20.22 T cells)Experimental treatment 11 interventions
Group B: Cohort B (TriCAR19.20.22 T cells)Experimental treatment 11 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
Up to 30 days after infusion
2

Recommended phase 2 dose

Time frame
Up to 30 days after infusion

Secondary outcomes

1

Incidence of adverse events (AEs)

Will be described and graded according to NCI CTCAE v 5.0. CRS will be described and graded using ASTCT Consensus Grading for CRS. Will be evaluated with descriptive statistics for the frequencies of AEs of different grades.

Time frame
Up to 30 days after infusion
2

Overall response rate

Will be evaluated with proportions used to describe response rates.

Time frame
Up to 15 years
3

Complete response rate

Will be evaluated with proportions used to describe response rates.

Time frame
Up to 15 years
4

Overall survival

Will be calculated using Kaplan-Meier method, comparisons between groups will be done using the log rank test.

Time frame
Up to 15 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ohio State University Comprehensive Cancer Center

Lead sponsor

Source ClinicalTrials.gov
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