A Phase I/II Study to Evaluate the Safety of Cellular Immunotherapy Using Autologous T Cells Engineered to Express a CD20-Specific Chimeric Antigen Receptor for Patients With Relapsed or Refractory B Cell Non-Hodgkin Lymphomas

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Macroglobulinemia Investigating the Safety and Efficacy of Rituximab and Pembrolizumab in Relapsed/Refractory Waldenström’s Macroglobulinaemia An Open-label, Phase 2 Study of Acalabrutinib in Subjects With Waldenström Macroglobulinemia Simvastatin in Waldenstrom’s Macroglobulinemia Ibrutinib (PCI-32765) in Waldenstrom’s Macroglobulinemia Carfilzomib, Rituximab and Dexamethasone in Waldenstrom’s Macroglobulinemia Thalidomide and Rituximab in Waldenstrom’s Macroglobulinemia Comparison of ASCT and Conventional Chemotherapy in High Risk Waldenström Macroglobulinemia Fase II Study With BRB for Non-Hodgkin Lymphoplasmacytic Lymphoma/Waldenstrom Macroglobulinemia’s Study of Lenalidomide in Relapse/Refractory Waldenstrom Macroglobulinemia Efficacy of Bortezomib (Velcade(R)) in Patients With Advanced Waldenström Macroglobulinemia A Study of Daratumumab in Patients With Relapsed or Refractory Waldenström Macroglobulinemia A Study of Ulocuplumab And Ibrutinib in Symptomatic Patients With Mutated CXCR4 Waldenstrom’s Macroglobulinemia Study of Phosphatidylinositol-3-kinase (PI3K) Inhibitor Idelalisib (GS-1101) in Waldenström Macroglobulinemia Trial of Ixazomib, Dexamethasone and Rituximab in Patients With Untreated Waldenstrom’s Macroglobulinemia Study of Ibrutinib in Patients With Symptomatic, Previously Untreated Waldenstrom’s Macroglobulinemia, and Impact on Tumor Genomic Evolution Using Whole Genome Sequencing LBH589 in Relapsed or Relapsed and Refractory Waldenstrom’s Macroglobulinemia Everolimus, Bortezomib and/or Rituximab in Patients With Relapsed/Refractory Waldenstrom’s Macroglobulinemia A Phase II Trial of Ofatumumab in Subjects With Waldenstrom’s Macroglobulinemia Study of ABT-199 (GDC-199) In Patients With Relapsed Or Refractory Waldenström Macroglobulinemia Expression of Ku70/XRCC6 in Waldenström’s Macroglobulinemia Anti-Angiogenesis Therapy Using Thalidomide in Patients With Waldenstrom’s Macroglobulinemia Study of VTD in Waldenstrom’s Macroglobulinemia Dasatinib In Waldenström Macroglobulinemia The Comparison of RCD Versus BCD in Newly Diagnosed Waldenström Macroglobulinemia CC-5013 (Lenalidomide) and Rituximab in Waldenstrom’s Macroglobulinemia Combination Bortezomib and Rituximab in Patients With Waldenstrom’s Macroglobulinemia R-VRD Followed by Lenalidomide Maintenance in Patients With Waldenstrom’s Macroglobulinemia Phase 1/2 Dose Escalation Study in Patients With Relapsed or Refractory Waldenstrom’s Macroglobulinemia Antineoplaston Therapy in Treating Patients With Recurrent or Refractory Waldenstrom’s Macroglobulinemia Efficacy of First Line B-RI for Treatment Naive Waldenström’s Macroglobulinemia Sildenafil Citrate in Waldenstrom’s Macroglobulinemia Bortezomib (Velcade) in Waldenstrom’s Macroglobulinemia Phase II Study of Campath-1H Antibody to Treat Waldenstrom’s Macroglobulinemia

Brief Title

A Phase I/II Study to Evaluate the Safety of Cellular Immunotherapy Using Autologous T Cells Engineered to Express a CD20-Specific Chimeric Antigen Receptor for Patients With Relapsed or Refractory B Cell Non-Hodgkin Lymphomas

Official Title

A Phase I/II Study to Evaluate the Safety of Cellular Immunotherapy Using Autologous T Cells Engineered to Express a CD20-Specific Chimeric Antigen Receptor for Patients With Relapsed or Refractory B Cell Non-Hodgkin Lymphomas

Brief Summary

      The purpose of this research is to find the best dose of genetically modified T-cells, to
      study the safety of this treatment, and to see how well it works in treating patients with B
      cell non-Hodgkin lymphoma that has come back (relapsed) or did not respond to previous
      treatment (refractory).
    

Detailed Description

      OUTLINE:

      This is a phase I/II dose-escalation study of CD20-specific CAR T cell therapy.

      Patients undergo leukapheresis and may receive treatment after if needed for disease control.
      Patients then receive cyclophosphamide intravenously (IV). Patients may also receive
      fludarabine IV. After 36-96 hours, patients receive CD20-specific CAR T cell infusion IV over
      20-30 minutes.

      Patients will be actively participating in the study for approximately 15 months. The total
      time includes the time for the T cells to be made, the T cell infusion, and for approximately
      12 months after the T cell infusion is given. After completion of study treatment, patients
      are followed up for a minimum of 15 years.
    

Study Phase

Phase 1/Phase 2

Study Type

Interventional


Primary Outcome

Dose-limiting toxicity

Secondary Outcome

 Complete remission

Condition

Recurrent B-Cell Non-Hodgkin Lymphoma

Intervention

Chimeric Antigen Receptor T-Cell Therapy

Study Arms / Comparison Groups

 Treatment (CD20-specific CAR T cell, chemotherapy)
Description:  Patients undergo leukapheresis and may receive treatment after if needed for disease control. Patients then receive cyclophosphamide IV. Patients may also receive fludarabine IV. After 36-96 hours, patients receive CD20-specific CAR T cell infusion IV over 20-30 minutes.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Biological

Estimated Enrollment

35

Start Date

December 5, 2017

Completion Date

November 16, 2037

Primary Completion Date

November 16, 2022

Eligibility Criteria

        Inclusion Criteria:

          -  Patients must have B-cell non-Hodgkin lymphoma or chronic lymphocytic leukemia/small
             lymphocytic lymphoma. Eligible lymphoma subtypes include (but not limited to): mantle
             cell, follicular, lymphoplasmacytic, marginal zone, transformed indolent B cell
             lymphoma (including transformed chromic lymphoid leukemia [CLL]), or diffuse large B
             cell lymphoma that has relapsed after a response to at least one prior therapy regimen
             or is refractory to prior therapy. Patients with mantle cell lymphoma must have
             previously been treated with a BTK inhibitor and have either had disease progression,
             intolerance, or exposure to the drug for at least 3 months. Patients with de novo
             diffuse large B-cell lymphoma (DLBCL) must meet one of the following criteria:

               -  Biopsy-proven refractory disease after a frontline regimen containing both an
                  anthracycline and rituximab or other anti-CD20 antibody (i.e. "primary
                  refractory"), where any disease recurring within 6 months of completion of the
                  regimen is considered refractory

               -  Relapsed or refractory disease after at least one of the following:

                    -  At least 2 lines of therapy (including at least one with an anthracycline
                       and anti-CD20 antibody)

                    -  Autologous stem cell transplant

                    -  Allogeneic stem cell transplant

          -  Patients of any gender, race or ethnicity

          -  Patients must be capable of understanding and providing a written informed consent

          -  Negative serum pregnancy test within 2 weeks before enrollment for women of
             childbearing potential, defined as those who have not been surgically sterilized or
             who have not been free of menses for at least 1 year

          -  Fertile male and female patients must be willing to use an effective contraceptive
             method before, during, and for at least 4 months after the CAR T cell infusion

          -  Patients must have a Karnofsky performance status of >= 60%

          -  Confirmation of diagnosis by internal pathology review of initial or subsequent biopsy
             or other pathologic material at Fred Hutchinson Cancer Research Center (FHCRC)/Seattle
             Cancer Care Alliance (SCCA)/University of Washington (UW)/Harborview Medical Center
             (HMC)

          -  Evidence of CD20 expression by immunohistochemistry or flow cytometry on the tumor
             specimen obtained with the biopsy performed with screening; if the CD20 expression on
             the screening tumor biopsy is unclear or could not be assessed due to technical
             reasons, CD20 expression on a concomitant tumor specimen (such as marrow biopsy or
             circulating tumor cells) may be used to satisfy this requirement

          -  Serum creatinine =< 2.5

          -  Total bilirubin =< 3.0 mg/dL

          -  Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 5 x the upper
             limit of normal

          -  Adequate pulmonary function, defined as =< grade 1 dyspnea and saturated oxygen (SaO2)
             >= 92% on room air; if pulmonary function test (PFT)s are performed based on the
             clinical judgment of the treating physician, patients with forced expiratory volume in
             1 second (FEV1) >= 50% of predicted and carbon monoxide diffusing capability (DLCO)
             (corrected) of >= 40% of predicted will be eligible

          -  Adequate cardiac function, defined as left ventricular ejection fraction (LVEF) of >=
             50% as assessed by echocardiogram or multigated acquisition (MUGA) scan, or LVEF of
             45-49% and clearance by a cardiologist

          -  Measurable disease that can be accurately measured in at least one dimension as >= 2.0
             cm with computed tomography (CT), ultrasound, or magnetic resonance imaging (MRI)
             techniques; extranodal disease that is measurable by fludeoxyglucose F-18
             (FDG)-positron emission tomography (PET) imaging only will also be allowed; note that
             if an excisional biopsy was performed that removed the sole site of measurable
             disease, the patient will not be eligible for leukapheresis and generation of CAR T
             cell product

          -  ELIGIBILITY FOR LYMPHODEPLETION CHEMOTHERAPY: Absence of uncontrolled active infection
             (bacterial, fungal, viral, mycobacterial) not responding to treatment with
             antibiotics, antiviral agents, or antifungal agents

          -  ELIGIBILITY FOR LYMPHODEPLETION CHEMOTHERAPY: Absence of active autoimmune disease
             requiring ongoing systemic immunosuppressive therapy

          -  ELIGIBILITY FOR LYMPHODEPLETION CHEMOTHERAPY: Negative serum pregnancy test within 2
             weeks before lymphodepletion chemotherapy for women of childbearing potential, defined
             as those who have not been surgically sterilized or who have not been free of menses
             for at least 1 year

          -  ELIGIBILITY FOR LYMPHODEPLETION CHEMOTHERAPY: No treatment with any investigational
             agent on a different clinical trial between enrollment and lymphodepleting
             chemotherapy

          -  ELIGIBILITY FOR LYMPHODEPLETION CHEMOTHERAPY: Serum creatinine =< 2.5

          -  ELIGIBILITY FOR LYMPHODEPLETION CHEMOTHERAPY: Total bilirubin =< 3.0 mg/dL

          -  ELIGIBILITY FOR LYMPHODEPLETION CHEMOTHERAPY: AST and ALT =< 5 x the upper limit of
             normal

          -  ELIGIBILITY FOR LYMPHODEPLETION CHEMOTHERAPY: Adequate pulmonary function, defined as
             =< grade 1 dyspnea and SaO2 >= 92% on room air; if PFTs are performed based on the
             clinical judgment of the treating physician, patients with FEV1 >= 50% of predicted
             and DLCO (corrected) of >= 40% of predicted will be eligible

          -  ELIGIBILITY FOR LYMPHODEPLETION CHEMOTHERAPY: Adequate cardiac function, defined as
             left ventricular ejection fraction (LVEF) of >= 50% as assessed by echocardiogram or
             MUGA scan, or LVEF of 45-49% and clearance by a cardiologist; if subject receives
             cardiotoxic chemotherapy after enrollment, repeat echocardiogram or MUGA is required
             to reestablish eligible LVEF

          -  ELIGIBILITY FOR LYMPHODEPLETION CHEMOTHERAPY: Patients must have a Karnofsky
             performance status of >= 60%

          -  ELIGIBILITY FOR LYMPHODEPLETION CHEMOTHERAPY: Measurable disease that can be
             accurately measured in at least one dimension as >= 2.0 cm with CT, ultrasound, or MRI
             techniques; extranodal disease that is measurable by FDG-PET imaging only will also be
             allowed; note that if an excisional biopsy was performed that removed the sole site of
             measurable disease, the patient is not be eligible for lymphodepletion and CAR T cell
             infusion; measurable disease can be based on the imaging study done during the
             screening unless the patient received treatment in the interim, in which case imaging
             should be repeated

          -  ELIGIBILITY FOR LYMPHODEPLETION CHEMOTHERAPY: Patients must require no corticosteroid
             therapy or dose of less than 15 mg per day of prednisone or the equivalent; pulsed
             corticosteroid dose for disease control is acceptable until the day before the start
             of lymphodepletion

          -  ELIGIBILITY FOR LYMPHODEPLETION CHEMOTHERAPY: Patients must have no active acute or
             chronic GVHD

        Exclusion Criteria:

          -  Active autoimmune disease requiring systemic immunosuppressive therapy

          -  Patients requiring corticosteroid therapy at a dose of 15 mg or more per day of
             prednisone or the equivalent; pulsed corticosteroid dose for disease control is
             acceptable

          -  Patients who are human immunodeficiency virus (HIV) seropositive

          -  Women who are pregnant or breastfeeding

          -  Significant cardiovascular diseases within the past 6 months including uncontrolled
             congestive heart failure (> New York Heart Association [NYHA] class II), myocardial
             infarction, unstable angina, or uncontrolled arrhythmia

          -  History of severe immediate hypersensitivity reaction to cyclophosphamide or
             fludarabine

          -  History or presence of clinically relevant non-lymphoma central nervous system
             pathology, including seizures that are uncontrolled on anticonvulsant therapy (>= 1
             seizure in the last year), paresis, aphasia, stroke, severe brain injuries, dementia,
             Parkinson disease, cerebellar disease, or psychosis

          -  Treatment with any investigational agent on a different clinical trial within 4 weeks
             prior to enrollment, unless the patient is documented to be unresponsive to the
             therapy and at least 3 half-lives have elapsed prior to enrollment

          -  Treatment with any anti-CD19 or anti-CD20 antibody or antibody-drug conjugate therapy
             within 4 weeks before enrollment

          -  Previous treatment with CD19-targeted CAR T cells that has resulted in ongoing B cell
             aplasia at the time of enrollment; patients that demonstrate recovery of normal B
             cells (>= 20 B cells/ul) by flow cytometry at any point 28 days or later after CD19
             CAR T cell infusion will be considered to have functional loss of CD19 CAR T cells and
             are potentially eligible

          -  Known active central nervous system metastases and/or lymphomatous meningitis;
             patients with isolated cerebrospinal fluid (CSF) involvement detectable by flow
             cytometry are eligible if clinically asymptomatic and if abnormal B cells are reported
             to be less than 3% by flow cytometry; subjects with previously treated central nervous
             system (CNS) disease may participate provided: 1) any CNS-directed treatment was
             completed at least 1 month prior to enrollment, 2) imaging studies and CSF evaluation
             show no evidence of disease progression, and 3) any neurologic symptoms have returned
             to baseline

          -  Presence of active acute or chronic graft versus host disease (GVHD)

          -  Uncontrolled active infection (bacterial, fungal, viral, mycobacterial) not responding
             to treatment with intravenous antibiotics, antiviral or antifungal agents

          -  Patients with concurrent known additional malignancy that is progressing and/or
             requires active treatment; exceptions include squamous or basal cell carcinoma of the
             skin and low grade prostate carcinoma (Gleason grade =< 6)

          -  Patients with blood or platelet transfusion within 1 week prior to signing Consent A,
             or with platelets < 50,000/mm^3, neutrophils < 750/mm^3, or hemoglobin < 8.5 g/dL,
             unless the cytopenias are considered by the treating physician to be largely due to
             marrow involvement by lymphoma
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Mazyar Shadman, 206-667-5467, [email protected]

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT03277729

Organization ID

9738

Secondary IDs

NCI-2017-01595

Responsible Party

Sponsor

Study Sponsor

Fred Hutchinson Cancer Research Center

Collaborators

 National Cancer Institute (NCI)

Study Sponsor

Mazyar Shadman, Principal Investigator, Fred Hutch/University of Washington Cancer Consortium


Verification Date

April 2021