Last updated on March 2019

Cellular Immunotherapy Following Chemotherapy in Treating Patients With Recurrent Non-Hodgkin Lymphomas Chronic Lymphocytic Leukemia or B-Cell Prolymphocytic Leukemia


Brief description of study

This phase I trial studies the side effects and best dose of cellular immunotherapy following chemotherapy in treating patients with non-Hodgkin lymphomas, chronic lymphocytic leukemia or B-cell prolymphocytic leukemia that has come back. Placing a modified gene into white blood cells may help the body build an immune response to kill cancer cells.

Detailed Study Description

PRIMARY OBJECTIVES:

I. To assess the safety of adoptive therapy using ex vivo expanded autologous memory T cells (central memory T cells [Tcm] or nave and memory T-cells [Tn/mem]) that are enriched and genetically modified to express a CD19-specific, hinged optimized, CD28-costimulatory chimeric antigen receptor (CAR) as well as a truncated human epidermal growth factor receptor (EGFR) (CD19R[EQ]28zeta/truncated EGFR [EGFRt]+ Tcm or CD19R[EQ]28zeta/EGFRt+ Tn/mem) shortly following lymphodepletion for adults with recurrent/progressive/residual CD19 + B-cell lymphoproliferative neoplasms (non-Hodgkin lymphoma [NHL], chronic lymphocytic leukemia [CLL]/prolymphocytic leukemia [PLL]) and who are not eligible for or decline City of Hope (COH) Institutional Review Board (IRB) Protocol Number (No.) 13277.

II. To determine the recommended Phase II dose (RP2D) in the two Tn/mem strata (NHL; CLL/PLL).

SECONDARY OBJECTIVES:

I. To study antitumor activity of CD19R(EQ)CD28zeta/EGFRt+Tcm or CD19R[EQ]28zeta/EGFRt+ Tn/mem (e.g., detection of CAR+T cells, B cells, and tumor burden).

OUTLINE: This is a dose-escalation study of autologous CD19CAR-CD28-CD3zeta-EGFRt-expressing enriched T cells (T-cell infusion).

LYMPHODEPLETING REGIMEN: Patients receive a chemotherapy regimen based on disease type and extent of disease comprising: cyclophosphamide intravenously (IV) on days -4 and/or -3; OR bendamustine hydrochloride IV on days -4 and -3; OR fludarabine phosphate IV and cyclophosphamide IV on days -5 to -3; OR etoposide IV and cyclophosphamide IV on days -5 to -3; OR cyclophosphamide IV on days -7 and -6 followed by etoposide IV on days -5 to -3.

CELLULAR IMMUNOTHERAPY: Beginning 3-10 days later after lymphodepletion, patients receive autologous CD19CAR-CD28-CD3zeta-EGFRt-expressing Tcm-enriched T cells or autologous CD19CAR-CD28-CD3zeta-EGFRt-expressing Tn/mem-enriched T-lymphocytes IV over 10-15 minutes on day 0. Patients with relapsed, residual or progressive disease may receive an optional second infusion of autologous CD19CAR-CD28-CD3zeta-EGFRt-expressing Tcm-enriched T cells or autologous CD19CAR-CD28-CD3zeta-EGFRt-expressing Tn/mem-enriched T-lymphocytes >= 28 days post T cell infusion.

After completion of study treatment, patients are followed up at every 2 days for 14 days, weekly for 1 month, monthly for 1 year, and then yearly for at least 15 years

Clinical Study Identifier: NCT02153580

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Recruitment Status: Open


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