Mesothelin-targeted CAR T-cell Therapy in Patients With Mesothelioma

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Pleurectomy/Decortication (Neo) Adjuvant Chemotherapy and Intensity Modulated Radiation Therapy to the Pleura in Patients With Locally Advanced Malignant Pleural Mesothelioma Pembrolizumab and Hypofractionated Stereotactic Radiotherapy in Patients With Malignant Pleural Mesothelioma Study of CBP501 + Pemetrexed + Cisplatin on MPM (Phase I/II) NGR015: Study in Second Line for Patient With Advanced Malignant Pleural Mesothelioma Pretreated With Pemetrexed Dendritic Cell-based Immunotherapy in Mesothelioma MTG201 Plus Nivolumab in Patients With Relapsed Pleural Mesothelioma Nintedanib in Treating Patients With Malignant Pleural Mesothelioma That Is Recurrent Active Symptom Control With or Without Chemotherapy in Treating Patients With Malignant Pleural Mesothelioma Do Your Genes Put You at a Higher Risk of Developing Mesothelioma Trimodality Therapy for Malignant Pleural Mesothelioma Pleurectomy/Decortication Followed by Intrathoracic/Intraperitoneal Heated Cisplatin for Malignant Pleural Mesothelioma Intracavitary Cisplatin-Fibrin Localized Chemotherapy After P/D or EPP for Malignant Pleural Mesothelioma Ganetespib With Platinum, in Patients With Malignant Pleural Mesothelioma Efficacy & Safety of rAd-IFN Administered With Celecoxib & Gemcitabine in Patients With Malignant Pleural Mesothelioma A Phase 2 Study of Durvalumab in Combination With Tremelimumab in Malignant Pleural Mesothelioma Prospectively Collected Pleural Biopsies for Validation of Malignant Pleural Mesothelioma Prognostic Biomarkers Phase II Study of Six Hours Low Dose Gemcitabine Plus Cisplatin in the Treatment for Advanced Pleural Mesothelioma Safety and Efficacy of Listeria in Combination With Chemotherapy as Front-line Treatment for Malignant Pleural Mesothelioma Intrapleural Photodynamic Therapy in a Multimodal Treatment for Patients With Malignant Pleural Mesothelioma Re-directed T Cells for the Treatment (FAP)-Positive Malignant Pleural Mesothelioma Concurrent Pemetrexed/Cisplatin With Pleural Intensity Modulated Radiation Therapy for Patients With Unresectable Malignant Pleural Mesothelioma Study of Cytoreductive Surgery and Hyperthermic Intraoperative Chemotherapy With Pemetrexed and Cisplatin for Malignant Pleural Mesotheliomas Effect of FAS and FAS Ligand Polymorphisms on Patients With Platinum-Based -Treated Malignant Pleural Mesothelioma Dasatinib in Resectable Malignant Pleural Mesothelioma Palliative Treatment With Liposomal Doxorubicin Plus Cisplatin for Patients With Malignant Pleural Mesothelioma Effect of Expression of CD74 and VEGF on Outcome of Treatment in Patients With Malignant Pleural Mesothelioma Clinical Study of YS110 in Patients With Malignant Pleural Mesothelioma Lurbinectedin Monotherapy in Patients With Progressive Malignant Pleural Mesothelioma. 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Placebo Controlled Study of VS-6063 in Subjects With Malignant Pleural Mesothelioma Response Evaluation in Malignant Pleural Mesothelioma Gemcitabine in Long Infusion and Cisplatin for Malignant Pleural Mesothelioma Treatment

Brief Title

Mesothelin-targeted CAR T-cell Therapy in Patients With Mesothelioma

Official Title

A Single-Arm, Open-Label, Phase I Trial to Assess the Safety of Genetically Engineered Autologous T Cells Targeting the Cell Surface Antigen Mesothelin With Cell-Intrinsic Checkpoint Inhibition in Patients With Mesothelioma

Brief Summary

      This study will test the safety of MSLN-targeted CAR-T cells at different doses to find the
      safest dose to give to people with MPM. The researchers want to see what effects, if any, the
      study treatment has on people with this type of cancer. This study is the first time that an
      MSLN-targeted CAR-T cell treatment with an anti-PD1 component is being given to people.
    


Study Phase

Phase 1

Study Type

Interventional


Primary Outcome

MTD of M28z1XXPD1DNR

Secondary Outcome

 overall response rate (ORR)

Condition

Malignant Pleural Mesothelioma (MPM)

Intervention

cyclophosphamide

Study Arms / Comparison Groups

 Engineered Autologous T Cells
Description:  Following eligibility screening and enrollment, patients will undergo leukapheresis for the collection of peripheral blood mononuclear cells (PBMCs), to enable generation of M28z1XXPD1DNR. Following successful M28z1XXPD1DNR CAR T-cell manufacturing, patients will be reevaluated for eligibility. A preconditioning regimen of one dose of intravenous (IV) cyclophosphamide 1.5 g/m2 will be administered 2-7 days before the infusion. A single dose of M28z1XXPD1DNR CAR T cells will be instilled into the pleural cavity via a pleural catheter or through an interventional radiology-guided needle. All patients will be monitored in the hospital for a minimum of 48 h following the administration of CAR T cells.

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

Drug

Estimated Enrollment

30

Start Date

September 30, 2020

Completion Date

September 2022

Primary Completion Date

September 2022

Eligibility Criteria

        Inclusion Criteria:

        1. Aged ≥18 years 2. Karnofsky performance status ≥70% 3. Pathologically confirmed MPM

          1. Epithelioid or biphasic histologic diagnosis provided that ≥10% of the tumor expresses
             MSLN by IHC analysis

          2. Patients with peritoneal mesothelioma with pleural involvement are eligible only if
             there is radiographic and pathologic confirmation of mesothelioma in the pleural
             cavity and ≥10% of the tumor expresses MSLN by IHC analysis. 4. Previously treated
             with at least 1 treatment regimen 5. Measurable or evaluable disease (disease is
             considered evaluable but not measurable if it does not meet the eligibility criteria
             for mRECIST but is a manifestation of malignancy that can be followed qualitatively as
             an indicator of disease progression or treatment response) 6. Chemotherapy, targeted
             therapy, or radiotherapy must be completed at least 7 days before leukapheresis.

        a. CPI must be completed at least 21 days before leukapheresis. 7. Chemotherapy, targeted
        therapy, or therapeutic radiotherapy must be completed at least 14 days before
        administration of T cells.

        a. Palliative radiotherapy can be completed 2 days before lymphodepletion. Immunotherapy
        with CPI must be completed at least 42 days before administration of T cells. 9. Any major
        thoracic (thoracotomy with lung or esophageal resection) or abdominal (laparotomy with
        organ resection) operation must have occurred at least 28 days before study enrollment.
        Patients who have undergone diagnostic VATS or laparoscopy can be included in the study.
        10. All acute toxic effects of any previous therapeutic or palliative radiotherapy,
        chemotherapy, or surgical procedures must have resolved to grade 1 (CTCAE v5.0).

        11. Lab requirements (hematology):

          1. Absolute neutrophil count ≥1.5 K/mcL

          2. Platelet count ≥100 K/mcL 12. Lab requirements (serum chemistry):

          1. Bilirubin ≤1.5x upper limit of normal (ULN)

          2. Serum alanine aminotransferase and serum aspartate aminotransferase (ALT/AST) level
             ≤5x ULN

          3. Serum creatinine level ≤1.5x ULN or creatinine >1.5x ULN but calculated clearances of
             >60 by Cockcroft-Gault Equation 13. Negative screen for infectious disease markers
             including Hepatitis B core antibody, Hepatitis B surface antigen, Hepatitis C
             antibody, HIV 1-2 antibody, HTLV 1-2 and Syphilis (rapid plasma regain profile) 14.
             Life expectancy at the time of screening ≥4 months

        Exclusion Criteria:

          1. Patients receiving therapy for concurrent active malignancy a. Patients receiving
             treatment for in situ skin malignancies are not excluded.

          2. Patients who received prior CAR T-cell therapy

          3. Untreated or active central nervous system (CNS) metastases (progressing or requiring

          4. anticonvulsants or corticosteroids for symptomatic control). Patients with a history
             of treated CNS metastases are eligible if all the following criteria are met:

               1. Presence of measurable or evaluable disease outside of the CNS

               2. Radiographic demonstration of improvement upon completion of CNS-directed therapy
                  and no evidence of interim progression between completion of CNSdirected therapy
                  and the screening radiographic study

               3. Completion of radiotherapy ≥8 weeks before the screening radiographic study

               4. Discontinuation of corticosteroids and anticonvulsants ≥4 weeks before the
                  screening radiographic study

          5. History of seizure disorder

          6. Active autoimmune disease that has required systemic treatment in the past year (with
             use of disease-modifying agents, corticosteroids, or immunosuppressive drugs) a.
             Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid
             replacement therapy for adrenal or pituitary insufficiency) is not considered a form
             of systemic treatment and is allowed.

          7. Patients who are receiving daily systemic corticosteroids that are above physiological
             doses for any reason or who are under immunosuppressive or immunomodulatory treatment

          8. Patients with the below cardiac conditions:

               1. New York Heart Association stage III or IV congestive heart failure

               2. Myocardial infarction ≤6 months before enrollment

               3. History of myocarditis

               4. Serious uncontrolled cardiac arrhythmia, unstable angina, or uncontrolled
                  infection

          9. Patients with left ventricular ejection fraction ≤40%

         10. Patients with active interstitial lung disease/pneumonitis or a history of
             interstitial lung disease/pneumonitis requiring treatment with systemic steroids

         11. Baseline pulse oximetry <90% on room air at the screening timepoint

         12. Pregnant or lactating women

             a. Subjects and their partners with reproductive potential must agree to use an
             effective form of contraception during treatment and for 1 year following treatment.

         13. Known active infection requiring antibiotic treatment 7 days before the start of
             treatment (Day 0). Note: treatment can be delayed at the discretion of the treating
             physician to allow the patient to recover from the infection.

         14. Administration of live, attenuated vaccine within 8 weeks before the start of
             treatment (Day 0) and for 100 days following treatment.

         15. Any other medical condition that, in the opinion of the PI, may interfere with a
             subject's participation in or compliance with the study

         16. Any patient deemed to be noncompliant by the study team for administration of a high
             risk treatment agent and for close follow-up after treatment as required by the
             protocol
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Roisin O'Cearbhaill, MD, 646-888-4227, [email protected]

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT04577326

Organization ID

20-328


Responsible Party

Sponsor

Study Sponsor

Memorial Sloan Kettering Cancer Center

Collaborators

 Atara Biotherapeutics

Study Sponsor

Roisin O'Cearbhaill, MD, Principal Investigator, Memorial Sloan Kettering Cancer Center


Verification Date

October 2020