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

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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

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

Official Title

Phase I Study to Evaluate Cellular Immunotherapy Using Memory-Enriched T Cells Lentivirally Transduced to Express a CD19-Specific, Hinge-Optimized, CD28-Costimulatory Chimeric Receptor and a Truncated EGFR Following Lymphodepleting Chemotherapy in Adult Patients With CD19+ B-Cell Lymphoproliferative Neoplasms

Brief Summary

      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 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 naive and memory T-cells [Tn/mem]) that are enriched and
      genetically modified to express a cluster of differentiation (CD)19-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 OBJECTIVE:

      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). Participants are assigned to 1 of 2 groups based on
      disease status.

      GROUP I (NON-HODGKIN LYMPHOMA [NHL]):

      LYMPHODEPLETING REGIMEN: Patients receive a chemotherapy regimen based on disease type and
      extent of disease comprising of cyclophosphamide, bendamustine hydrochloride, fludarabine
      phosphate, etoposide.

      CELLULAR IMMUNOTHERAPY: Beginning 3-10 days later after lymphodepletion, patients receive
      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 Tn/mem-enriched
      T-lymphocytes >= 28 days post T cell infusion.

      GROUP II (CHRONIC LYMPHOCYTIC LEUKEMIA [CLL] AND/OR PROLYMPHOCYTIC LEUKEMIA [PLL]):

      LYMPHODEPLETING REGIMEN: Patients receive a chemotherapy regimen based on disease type and
      extent of disease comprising of cyclophosphamide, bendamustine hydrochloride, fludarabine
      phosphate, etoposide.

      CELLULAR IMMUNOTHERAPY: Beginning 3-10 days later after lymphodepletion, patients receive
      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 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.
    

Study Phase

Phase 1

Study Type

Interventional


Primary Outcome

Toxicity profile of T-cell infusion as defined by all toxicities associated with T cells at the probably or definite levels

Secondary Outcome

 Detection of transferred T cells in the circulation for at least 28 days by quantitative-polymerase chain reaction

Condition

B-Cell Lymphoma, Unclassifiable, With Features Intermediate Between Diffuse Large B-Cell Lymphoma and Classic Hodgkin Lymphoma

Intervention

Autologous CD19CAR-CD28-CD3zeta-EGFRt-expressing Tn/mem-enriched T-lymphocytes

Study Arms / Comparison Groups

 Group I (lymphodepletion, cellular immunotherapy)
Description:  LYMPHODEPLETING REGIMEN: Patients receive a chemotherapy regimen based on disease type and extent of disease comprising of cyclophosphamide, bendamustine hydrochloride, fludarabine phosphate, etoposide.
CELLULAR IMMUNOTHERAPY: Beginning 3-10 days later after lymphodepletion, patients receive 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 Tn/mem-enriched T-lymphocytes >= 28 days post T cell infusion.
Disease status: Patients with Non-Hodgkin lymphoma (NHL).

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

54

Start Date

September 24, 2014

Completion Date

December 31, 2021

Primary Completion Date

December 31, 2021

Eligibility Criteria

        Inclusion Criteria:

          -  SCREENING INCLUSION CRITERIA:

          -  COH pathology review confirms that research participant's diagnostic material is
             consistent with recurrent/progressive/residual B cell lymphoproliferative neoplasms as
             listed below AND the research participant is not eligible for or declines COH IRB
             Protocol No. 13277; additionally, CD19 positivity must be documented in a pathology
             report if the research participant previously received CD19-targeted therapy; however,
             it is not a requirement that the CD19 testing be performed by a COH pathologist

               -  Disease stratum 1 (NHL): Unclassifiable high grade lymphoma, mantle cell
                  lymphoma, follicular lymphoma, diffuse large B-cell lymphoma (DLBCL) and all its
                  subtypes, Burkitt lymphoma (BL), marginal zone B-cell lymphoma, hairy cell
                  leukemia, lymphoplasmacytic lymphoma, B cell lymphoma unclassifiable with
                  features intermediate between DLBCL and BL, B cell lymphoma unclassifiable with
                  features intermediate between DLBCL and classical Hodgkin lymphoma, and those
                  research participants who either declined or were not eligible for COH IRB
                  Protocol No. 13277, or who collected autologous T cells for COH IRB Protocol No.
                  13277 but then became ineligible for autologous hematopoietic stem cell
                  transplant (HSCT) or participants who have relapsed following prior T cell
                  therapy on either COH IRB Protocol No. 09174 or 12224 may be enrolled on this
                  study

               -  Disease stratum 2 (CLL/PLL/SLL): chronic lymphocytic leukemia (CLL), and B-cell
                  prolymphocytic leukemia (PLL), and small lymphocytic lymphoma (SLL)

          -  Karnofsky performance status (KPS) of >= 70%

          -  Life expectancy >= 16 weeks at time of screening

          -  The effects of CD19R(EQ)28zeta/EGFRt+ TCM or CD19R(EQ)28zeta/EGFRt+ TN/MEM on the
             developing fetus are unknown; for this reason, women of child-bearing potential and
             men must agree to use adequate contraception (hormonal or barrier method of birth
             control or abstinence) prior to study entry and for six months following duration of
             study participation; should a woman become pregnant or suspect that she is pregnant
             while participating on the trial, she should inform her treating physician immediately

          -  All subjects must have the ability to understand and the willingness to sign a written
             informed consent

               -  Note: For research participants who do not speak English, a short form consent
                  may be used with a COH certified interpreter/translator to proceed with screening
                  and leukapheresis, while the request for a translated full consent is processed;
                  however, the research participant is allowed to proceed with lymphodepletion and
                  T cell infusion only after the translated full consent form is signed

          -  PROTOCOL-SPECIFIC CRITERIA:

          -  COH pathology review confirms that research participant's diagnostic material is
             consistent with a lymphoproliferative B-cell neoplasm

          -  Documentation of recurrence/progression/residual disease following prior therapy

          -  Negative serum pregnancy test for women of childbearing potential

          -  A pretreatment creatinine clearance (CrCl) of >= 60 mL/minute (min), calculated by
             Cockcroft Gault

          -  Patients must have a serum bilirubin =< 2.0 mg/dl

          -  Patients must have an alanine aminotransferase (ALT) and aspartate aminotransferase
             (AST) =< 2.5 times the institutional upper limits of normal

          -  Ejection fraction measured by echocardiogram or multi gated acquisition scan (MUGA) >
             45% (evaluation within 6 weeks of screening does not need to be repeated)

          -  ELIGIBILITY TO PROCEED WITH PERIPHERAL BLOOD MONONUCLEAR CELL (PBMC) COLLECTION

          -  Research participant must have appropriate venous access

          -  Research participant must be at least 2 weeks from having received the last dose of
             immunosuppressant medications (e.g. calcineurin inhibitors, methotrexate,
             immunosuppressive antibodies, etc)

          -  The last dose of prior chemotherapy, immunotherapy or radiation must be at least 2
             weeks before the leukapheresis procedure

          -  The last dose of cytotoxic chemotherapeutic agents that are not considered lymphotoxic
             must be at least one week before the leukapheresis procedure; oral chemotherapeutic
             agents, including lenalidomide and ibrutinib, are allowed if at least 3 half-lives
             have elapsed prior to leukapheresis

          -  The last dose of lymphotoxic chemotherapeutic agents (e.g. cyclophosphamide,
             ifosofamide, bendamustine, etc) must be at least 2 weeks before the leukapheresis
             procedure

          -  The last dose of investigational agents must be at least 2 weeks before leukapheresis
             procedure unless no response or disease progression is documented on the experimental
             therapy and at least 3 half-lives must have elapsed prior to leukapheresis

          -  Note: exceptions may be made at the discretion of the principal investigator
             (PI)/study team

          -  ELIGIBILITY TO UNDERGO LYMPHODEPLETION:

          -  Research participant has a released cryopreserved T cell product for T cell infusions
             on approximately day 0

          -  Research participant must be at least 2 weeks out from having received the last dose
             of investigational agent

          -  The last dose of cytotoxic chemotherapeutic agents that are not considered lymphotoxic
             must be at least one week before lymphodepletion; oral chemotherapeutic agents,
             including lenalidomide and ibrutinib, are allowed if at least 3 half-lives have
             elapsed prior to lymphodepletion

          -  The last dose of lymphotoxic chemotherapeutic agents (e.g. cyclophosphamide,
             ifosofamide, bendamustine, etc) must be at least 2 weeks before lymphodepletion

          -  Toxicity related to prior therapy must either have returned to =< grade 3, baseline,
             or deemed irreversible

          -  KPS >= 70%

          -  Participants of reproductive potential must agree to use and utilize an adequate
             method of contraception throughout treatment and for at least 8 weeks after T cell
             infusion

          -  Absolute neutrophil count (ANC) > 0.75

          -  Platelets > 50 K without growth factor or transfusion support for a week at least

          -  Not requiring supplemental oxygen or mechanical ventilation, oxygen saturation 90% or
             higher on room air

          -  Not requiring pressor support, not having symptomatic cardiac arrhythmias

          -  Preservation of renal function, serum creatinine did NOT increase by more than 2 fold
             above the normal range

          -  Total bilirubin =< 2.0 mg/dL

          -  Research participant without clinically significant encephalopathy/new focal deficits

          -  No clinical evidence of uncontrolled active infectious process

          -  (ELIGIBILITY CRITERIA AT TIME OF INFUSION OF GENETICALLY MODIFIED AUTOLOGOUS T CELLS):
             Research participant has completed prescribed lymphodepletion

          -  (ELIGIBILITY CRITERIA AT TIME OF INFUSION OF GENETICALLY MODIFIED AUTOLOGOUS T CELLS):
             Not requiring supplemental oxygen or mechanical ventilation, oxygen saturation 90% or
             higher on room air

          -  (ELIGIBILITY CRITERIA AT TIME OF INFUSION OF GENETICALLY MODIFIED AUTOLOGOUS T CELLS):
             Not requiring pressor support, not having symptomatic cardiac arrhythmias

          -  (ELIGIBILITY CRITERIA AT TIME OF INFUSION OF GENETICALLY MODIFIED AUTOLOGOUS T CELLS):
             Preservation of renal function, serum creatinine did NOT increase by more than 2 fold
             above the normal range

          -  (ELIGIBILITY CRITERIA AT TIME OF INFUSION OF GENETICALLY MODIFIED AUTOLOGOUS T CELLS):
             Total bilirubin =< 2.0 mg/dL

          -  (ELIGIBILITY CRITERIA AT TIME OF INFUSION OF GENETICALLY MODIFIED AUTOLOGOUS T CELLS):
             Research participant without clinically significant encephalopathy/new focal deficits

          -  (ELIGIBILITY CRITERIA AT TIME OF INFUSION OF GENETICALLY MODIFIED AUTOLOGOUS T CELLS):
             No clinical evidence of uncontrolled active infectious process

        Exclusion Criteria:

          -  SCREENING EXCLUSION CRITERIA:

          -  Research participants who received memory-enriched CD19R(EQ):CD28:zeta/EGFRt+ on
             IRB#13277

          -  Research participants with any uncontrolled illness including ongoing or active
             infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
             arrhythmia, poorly controlled pulmonary disease or psychiatric illness/social
             situations that would limit compliance with study requirements

          -  Research participants with known active hepatitis B or C infection; research
             participants who are human immunodeficiency virus (HIV) seropositive based on testing
             performed within 4 weeks of screening; research participants with any signs of
             symptoms of active infection, positive blood cultures or radiological evidence of
             infections

          -  Research participants with presence of other active malignancy; however, research
             participants with history of prior malignancy treated within 2 years with curative
             intent and in a complete remission are eligible

          -  Pregnant and lactating women

          -  STUDY-SPECIFIC EXCLUSIONS:

          -  Failure of research participant to understand the basic elements of the protocol
             and/or the risks/benefits of participating in this phase I study

          -  Research participants with precursor B-cell acute lymphoblastic leukemia/lymphoma or
             plasma cell dyscrasias

          -  Any known contraindications to cyclophosphamide, fludarabine, etoposide, bendamustine,
             cetuximab or tocilizumab

          -  Dependence on corticosteroids

               -  Steroid dependence can be defined as a medical need to be greater than 5 mg of
                  prednisone (or equivalent doses of other systemic steroids) a day, chronically;
                  higher doses need to be avoided for at least 3 days prior to leukapheresis and,
                  again, for at least 3 days prior to T cell infusion and up to at least 3 months
                  after T cell infusion unless medically indicated to treat a new toxicity

               -  Note: topical and inhaled corticosteroids in standard doses and physiologic
                  replacement for subjects with adrenal insufficiency are allowed

          -  Active autoimmune disease requiring systemic immunosuppressive therapy

          -  Subjects, who in the opinion of the investigator, may not be able to comply with the
             safety monitoring requirements of the study
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Tanya Siddiqi, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT02153580

Organization ID

13351

Secondary IDs

NCI-2014-01168

Responsible Party

Sponsor

Study Sponsor

City of Hope Medical Center

Collaborators

 National Cancer Institute (NCI)

Study Sponsor

Tanya Siddiqi, Principal Investigator, City of Hope Medical Center


Verification Date

March 2021