CD19-Specific T Cells Post AlloSCT

Stopped early · Phase 1

Conditions studied: B Acute Lymphoblastic Leukemia With t(v;11q23.3); KMT2A Rearranged, Recurrent B Acute Lymphoblastic Leukemia, Recurrent Chronic Lymphocytic Leukemia, Recurrent Diffuse Large B-Cell Lymphoma, Not Otherwise Specified, Recurrent Mantle Cell Lymphoma, Recurrent Non-Hodgkin Lymphoma, Recurrent Ph-Like Acute Lymphoblastic Leukemia, Recurrent Primary Mediastinal (Thymic) Large B-Cell Cell Lymphoma, Recurrent Small Lymphocytic Lymphoma, Refractory B Acute Lymphoblastic Leukemia, Refractory Chronic Lymphocytic Leukemia, Refractory Diffuse Large B-Cell Lymphoma, Not Otherwise Specified, Refractory Mantle Cell Lymphoma, Refractory Non-Hodgkin Lymphoma, Refractory Ph-Like Acute Lymphoblastic Leukemia, Refractory Primary Mediastinal (Thymic) Large B-Cell Cell Lymphoma, Refractory Small Lymphocytic Lymphoma

In brief

This phase I trial investigates the side effects and best dose of CD19 positive (+) specific CAR-T cells in treating patients with CD19+ lymphoid malignancies, such as acute lymphoblastic leukemia, non-Hodgkin lymphoma, small lymphocytic lymphoma, or chronic lymphocytic lymphoma. Sometimes researchers change the genetic material in the cells of a patient's T cells using a process called gene transfer. Researchers then inject the changed T-cells into the patient's body. Receiving the T-cell infusion may help to control the disease.

Key facts

Study ID

NCT03579888

Run by

M.D. Anderson Cancer Center

People needed

4

Starts

2020-06-26

Expected to finish

2021-05-27

Last updated by the study team

2021-06-02

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• RECIPIENT: Patients with high risk or relapsed disease who are planning to receive, or have received prior allogeneic HSCT from an human leukocyte antigen (HLA)-matched related, or HLA-mismatched related donor; high risk is defined as patients with acute lymphoblastic leukemia who have delayed clearance of minimal residual disease, Philadelphia (Ph)-like, or complex, 11q23 or hypodiploid karyotype
• RECIPIENT: Available donor who provided hematopoietic stem-cell (HSC)
• RECIPIENT: Patients with CD19+ lymphoid malignancies that are refractory to or intolerant of standard treatment (as defined below):
• B-cell Acute Lymphoblastic Leukemia (ALL)
• Non-Hodgkin lymphoma (NHL) to include diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primary mediastinal large B cell lymphoma, mantle cell lymphoma, or transformed follicular lymphoma (TFL) as defined by the World Health Organization 2008 criteria
• Small lymphocytic lymphoma (SLL)
• Chronic lymphocytic leukemia (CLL)
• NOTE: Refractory disease for acute and chronic leukemia is defined by:
• Presence of > 5% malignant blasts in bone marrow and/or peripheral blood and/or minimal residual disease by flow cytometry or molecular analysis for fusion proteins and/or positive imaging for extra-medullary disease to most recent therapy
• NOTE: Refractory disease for lymphoma is defined as:
• Progressive disease or stable disease lasting =< 6 months, as best response to most recent chemotherapy regimen; or disease progression or recurrence =< 12 months after prior ASCT
• Prior therapy must have included an anti-CD20 monoclonal antibody-containing regimen and an anthracycline-containing chemotherapy regimen
• For patients with TFL, prior chemotherapy for follicular lymphoma and subsequent refractory disease after transformation to DLBCL
• At least one measurable lesion according to revised International Working Group (IWG) Response Criteria
• RECIPIENT: In patients with prior transplant, treatment will begin no earlier than 3 months post-transplant. Enrollment can occur earlier to allow time for donor cell collection
• RECIPIENT: Karnofsky performance scale > 60
• RECIPIENT: Patient able to provide written informed consent
• RECIPIENT: Patient able to provide written informed consent for the long-term follow-up (LTFU) gene therapy study
• RECIPIENT: Negative human anti-mouse antibody (HAMA)
• DONOR: HLA-matched related, HLA-mismatched related, including haploidentical donor, or related donor cleared to donate based on Stem Cell Transplantation and Cellular Therapy (SCTCT) standard-of-care (SOC) guidelines
• DONOR: Negative beta HCG in female of child-bearing potential defined as:
• Not post-menopausal for 12 months, or
• No previous surgical sterilization, or
• Lactating females
• T-CELL INFUSION REQUIREMENTS FOR RECIPIENT: Patient must have measurable disease at the time of treatment

You may not qualify if…

• RECIPIENT: Positive beta human chorionic gonadotropin (HCG) in female of child-bearing potential defined as not post-menopausal for 12 months or no previous surgical sterilization or lactating females
• RECIPIENT: Patients with allergy to mouse products or cetuximab
• RECIPIENT: Active central nervous system (CNS) disease in patient with history of CNS malignancy
• RECIPIENT: Positive serology for human immunodeficiency virus (HIV)
• RECIPIENT: Active hepatitis B or active hepatitis C
• RECIPIENT: Has received a T-cell product within 6 weeks prior to planned infusion of genetically modified T cells

Where it is running

• M D Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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