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Genetically Modified T-cells in Treating Patients With Recurrent or Refractory Malignant Glioma

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ClinicalTrials.gov Identifier: NCT02208362
Recruitment Status : Recruiting
First Posted : August 5, 2014
Last Update Posted : January 9, 2019
Sponsor:
Collaborators:
National Cancer Institute (NCI)
Gateway for Cancer Research
Mustang Bio, Inc.
California Institute for Regenerative Medicine (CIRM)
Information provided by (Responsible Party):
City of Hope Medical Center

August 1, 2014
August 5, 2014
January 9, 2019
May 18, 2015
May 2020   (Final data collection date for primary outcome measure)
  • Incidence of grade 3 toxicity, graded using the National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE) version 4.0, the revised cytokine release syndrome grading system as well as the modified neurological grading system [ Time Frame: Up to 15 years ]
  • Incidence of DLT, graded using NCI CTCAE version 4.0 [ Time Frame: Up to 1 week following the last course (not including optional courses 4-6) ]
    Rate and associated 90% Clopper and Pearson binomial confidence limits (90% confidence interval) will be estimated for participants' experiencing DLTs at the RP2D schedule.
  • Incidence of toxicities, graded using NCI CTCAE version 4.0 as well as the modified neurological grading system [ Time Frame: Up to 15 years ]
    Tables will be created to summarize all toxicities and side effects by dose, time post treatment, organ, severity and strata.
  • Incidence of grade 3 toxicity, graded using the National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE) version 4.0 as well as the modified neurological grading system [ Time Frame: Up to 15 years ]
  • Incidence of DLT, graded using NCI CTCAE version 4.0 [ Time Frame: Up to 1 week following the course 3 infusion ]
    Rate and associated 90% Clopper and Pearson binomial confidence limits (90% confidence interval) will be estimated for participants' experiencing DLTs at the RP2D schedule.
  • Incidence of toxicities, graded using NCI CTCAE version 4.0 as well as the modified neurological grading system [ Time Frame: Up to 15 years ]
    Tables will be created to summarize all toxicities and side effects by dose, time post treatment, organ, severity and strata.
Complete list of historical versions of study NCT02208362 on ClinicalTrials.gov Archive Site
  • Changes in largest length of tumor [ Time Frame: Baseline to up to 15 years ]
    Descriptive statistics will be provided for brain inflammation (largest length of tumor) pre and post treatment.
  • Changes in cytokine levels [ Time Frame: Baseline to up to 6 weeks ]
    Statistical and graphical methods will be used to describe the cytokine levels (cyst fluid, peripheral blood) over the study period.
  • Changes in CAR T cell levels [ Time Frame: Baseline to up to 6 weeks ]
    Statistical and graphical methods will be used to describe the CAR T cell levels (cyst fluid, peripheral blood) over the study period.
  • Progression free survival [ Time Frame: At 6 months ]
    Kaplan Meier methods will be used to estimate median PFS and graph the results.
  • Disease response by the Response Assessment in Neuro-Oncology criteria [ Time Frame: Up to 15 years ]
    Estimated using 90% confidence interval.
  • Overall survival (OS) [ Time Frame: Up to 15 years ]
    Kaplan Meier methods will be used to estimate median overall survival and graph the results. OS will also be examined for all patients, as well as, separately for those that received initial treatment only and those that received intraventricular infusion following progression
  • Changes in quality of life [ Time Frame: Baseline to up to 15 years ]
    Estimate the mean and standard error for change from baseline during treatment and post treatment in the quality of life functioning scale, symptom scale and item scores from the EORTC QLQ-C30 and the domain scale and items scores from the QLQ-BN20.
  • T cell detection in tumor [ Time Frame: Up to 1 year ]
    In study participants that undergo a second resection or following autopsy, T cells numbers, location, and antigen levels will be described.
  • IL13Ra2 antigen expression levels [ Time Frame: Up to 1 year ]
  • Disease response from intraventricular infusion following progression after intracranial infusion (stratum 1 and 2) [ Time Frame: Up to 15 years ]
    Estimated using 90% confidence
  • Changes in largest length of tumor [ Time Frame: Baseline to up to 15 years ]
    Descriptive statistics will be provided for brain inflammation (largest length of tumor) pre and post treatment.
  • Changes in cytokine levels [ Time Frame: Baseline to up to 6 weeks ]
    Statistical and graphical methods will be used to describe the cytokine levels (cyst fluid, peripheral blood) over the study period.
  • Progression free survival [ Time Frame: At 6 months ]
    Estimated using 90% confidence interval.
  • Disease response by MacDonald criteria [ Time Frame: Up to 15 years ]
    Estimated using 90% confidence interval.
  • Overall survival [ Time Frame: Up to 15 years ]
    Kaplan Meier methods will be used to estimate median overall survival and graph the results.
  • Changes in quality of life [ Time Frame: Baseline to up to 15 years ]
    Estimate the mean and standard error for change from baseline during treatment and post treatment in the quality of life functioning scale, symptom scale and item scores from the EORTC QLQ-C30 and the domain scale and items scores from the QLQ-BN20.
  • T cell detection in tumor [ Time Frame: Up to 1 year ]
    In study participants that undergo a second resection or following autopsy, T cells numbers, location, and antigen levels will be described.
  • IL13Ra2 antigen expression levels [ Time Frame: Up to 1 year ]
Not Provided
Not Provided
 
Genetically Modified T-cells in Treating Patients With Recurrent or Refractory Malignant Glioma
Phase I Study of Cellular Immunotherapy Using Memory Enriched T Cells Lentivirally Transduced to Express an IL13Rα2-Specific, Hinge-Optimized, 41BB-Costimulatory Chimeric Receptor and a Truncated CD19 for Patients With Recurrent/Refractory Malignant Glioma

This phase I trial studies the side effects and best dose of genetically modified T-cell immunotherapy in treating patients with malignant glioma that has come back (recurrent) or has not responded to therapy (refractory). A T cell is a type of immune cell that can recognize and kill abnormal cells in the body. T cells are taken from the patient's blood and a modified gene is placed into them in the laboratory and this may help them recognize and kill glioma cells. Genetically modified T-cells may also help the body build an immune response against the tumor cells.

Funding Source - FDA OOPD

PRIMARY OBJECTIVES:

I. To assess the feasibility and safety of cellular immunotherapy utilizing ex vivo expanded autologous memory-enriched T cells that are genetically modified using a self-inactivating (SIN) lentiviral vector to express an interleukin 13 receptor alpha 2 (IL13R alpha 2)-specific, hinge-optimized, 41BB-costimulatory chimeric antigen receptor (CAR), as well as a truncated human cluster of differentiation 19 (CD19) for participants with recurrent/refractory malignant glioma in one of the following ways: stratum 1 (intratumoral delivery of IL13 [EQ]BBzeta/truncated CD19[t]+ central memory T cells [Tcm]) (IL13R alpha 2-specific, hinge-optimized, 41BB-costimulatory CAR/truncated CD19-expressing T lymphocytes), stratum 2 (intracavitary delivery of IL13 [EQ]BBzeta/truncated CD19[t]+ Tcm, stratum 3 (intraventricular delivery of IL13 [EQ]BBzeta/truncated CD19[t]+ Tcm), stratum 4 (dual delivery [both intratumoral and intraventricular] of IL13 [EQ]BBzeta/truncated CD19[t]+ Tcm), or stratum 5 (dual delivery of IL13 [EQ]BBzeta/truncated CD19[t]+ naive and memory T cells [Tn/mem]).II. To determine maximum tolerated dose schedule (MTD) and a recommended phase II dosing plan (RP2D) for each stratum based on dose limiting toxicities (DLTs) and the full toxicity profile.

SECONDARY OBJECTIVES:

I. To assess the timing and extent of brain inflammation, as assessed by magnetic resonance imaging (MRI)/magnetic resonance spectroscopy (MRS), following T cell administration.

II. To describe cytokine levels (cyst fluid, peripheral blood) over the study period.

III. In research participants who receive the full schedule of three CAR+ T cell doses: estimate the six month progression free survival rate, disease response rates, and median overall survival.

IV. In research participants who receive intraventricular infusions after progressing following intratumoral/intracranial infusions (stratum 1 or 2): estimate disease response.

V. In research participants who receive at least one dose of CAR+ T cells estimate the mean change from baseline in quality of life using the European Organization for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ)-C30 and EORTC QLQ brain neoplasm (BN)-20 survey scale, domain and item scores during and post treatment.

VI. To evaluate CAR T cell persistence in the tumor micro-environment and the location of the CAR T cells with respect to the injection. (For research participants who undergo a second resection or autopsy).

VII. To evaluate IL13R alpha 2 antigen expression levels pre and post CAR T cell therapy. (For research participants who undergo a second resection or autopsy) OUTLINE: This is a dose-escalation study. Patients are assigned to 1 of 5 strata.

STRATUM I (Intratumoral delivery) CLOSED TO ACCRUAL 03/02/2018: Patients receive IL13R alpha 2-specific, hinge-optimized, 41BB-costimulatory CAR/truncated CD19-expressing T lymphocytes via intratumoral catheter over 5 minutes weekly for 3 weeks. Beginning as early as 1 week later, patients may receive additional T cell infusions as long as patients remain eligible and there is product available. Patients who progress on intracavitary or intratumoral administration may move to intraventricular catheter for the optional infusions.

STRATUM II (Intracavitary delivery): Patients receive IL13R alpha 2-specific, hinge-optimized, 41BB-costimulatory CAR/truncated CD19-expressing T lymphocytes via intracavitary catheter over 5 minutes weekly for 3 weeks. Beginning as early as 1 week later, patients may receive additional T cell infusions as long as patients continue to remain eligible and there is product available. Patients who progress on intracavitary or intratumoral administration may move to intraventricular catheter for the optional infusions.

STRATUM III (Intraventricular delivery): Patients receive IL13R alpha 2-specific, hinge-optimized, 41BB-costimulatory CAR/truncated CD19-expressing T lymphocytes via intraventricular catheter over 5 minutes weekly for 3 weeks. Beginning as early as 1 week later, patients may receive additional T cell infusions as long as patients continue to remain eligible and there is product available.

STRATUM IV (Dual delivery): Patients receive IL13R alpha 2-specific, hinge-optimized, 41BB-costimulatory CAR/truncated CD19-expressing T lymphocytes via intratumoral catheter and intraventricular catheter over 5 minutes weekly for 3 weeks. Beginning as early as 1 week later, patients may receive additional T cell infusions as long as patients continue to remain eligible and there is product available. Based on clinical response after the first 3 infusions, the study principal investigator may decide to continue with the optional infusions at either one or both sites (instead of requiring injections at both sites).

STRATUM V (Dual delivery): Patients receive IL13 [EQ]BBzeta/truncated CD19[t]+ Tn/mem via intratumoral catheter and intraventricular catheter over 5 minutes weekly for 3 weeks. Beginning as early as 1 week later, patients may receive additional T cell infusions as long as patients continue to remain eligible and there is product available. Based on clinical response after the first 3 infusions, the study principal investigator may decide to continue with the optional infusions at either one or both sites (instead of requiring injections at both sites).

After completion of study treatment, patients are followed up at 4 weeks, 3, 6, 8, 10 and 12 months and then yearly for 15 years.

Interventional
Phase 1
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Malignant Glioma
  • Refractory Brain Neoplasm
  • Recurrent Brain Neoplasm
  • Glioblastoma
  • Biological: IL13Rα2-specific, hinge-optimized, 41BB-costimulatory CAR/truncated CD19-expressing Autologous T lymphocytes
    Given via intratumoral or intracavitary or intraventricular catheter
    Other Name: autologous IL13(EQ)BBzeta/CD19t+ Tcm-enriched T cells
  • Other: laboratory biomarker analysis
    Correlative studies
  • Other: quality-of-life assessment
    Ancillary studies
    Other Name: quality of life assessment
  • Procedure: Magnetic Resonance Imaging
    Correlative studies
    Other Names:
    • Magnetic Resonance Imaging Scan
    • Medical Imaging, Magnetic Resonance/Nuclear Magnetic Resonance
    • MRI
    • MRI Scan
    • NMR Imaging
    • NMRI
    • Nuclear Magnetic Resonance Imaging
  • Procedure: Magnetic Resonance Spectroscopic Imaging
    Correlative studies
    Other Names:
    • 1H- Nuclear Magnetic Resonance Spectroscopic Imaging
    • Magnetic Resonance Spectroscopy
    • MRS
    • MRS Imaging
    • MRSI
    • Proton Magnetic Resonance Spectroscopic Imaging
  • Biological: IL13Rα2-specific, hinge-optimized, 41BB-costimulatory CAR/truncated CD19-expressing Autologous T lymphocytes
    Given via intratumoral and intraventricular catheter
    Other Name: autologous IL13(EQ)BBzeta/CD19t+ Tcm-enriched T cells
  • Biological: Vaccine Therapy
    Given IL13 [EQ]BBzeta/truncated CD19[t]+ Tn/mem via intratumoral or intraventricular catheter
  • Procedure: Magnetic Resonance Imaging
    Correlative studies
    Other Names:
    • Medical Imaging
    • Magnetic Resonance / Nuclear Magnetic Resonance
    • MRI
    • MRI Scan
    • NMR Imaging
    • NMRI
    • Nuclear Magnetic Resonance Imaging
  • Procedure: Magnetic Resonance Spectroscopic Imaging
    Correlative Studies
    Other Names:
    • 1H- Nuclear Magnetic Resonance
    • Spectroscopic Imaging
    • 1H-nuclear magnetic resonance spectroscopic imaging
    • Magnetic Resonance Spectroscopy
    • MRS
    • MRS Imaging
    • MRSI
    • proton magnetic resonance spectroscopic imaging
  • Other: Laboratory Biomarker Analysis
    Correlative Studies
  • Other: Quality of Life Assessment
    Ancillary Studies
    Other Name: Quality-of-Life Assessment
  • Experimental: Stratum I (T lymphocytes intratumoral)

    CLOSED TO ACCRUAL 03/02/2018

    Patients receive IL13Rα2-specific, hinge-optimized, 41BB-costimulatory CAR/truncated CD19-expressing T lymphocytes via intratumoral catheter over 5-10 minutes weekly for 3 weeks. Beginning as early as 1 week later, patients may receive additional T cell infusions as long as patients continue to remain eligible and there is product available. Patients who progress on intracavitary or intratumoral administration may move to intraventricular catheter for the optional infusions.

    Interventions:
    • Biological: IL13Rα2-specific, hinge-optimized, 41BB-costimulatory CAR/truncated CD19-expressing Autologous T lymphocytes
    • Other: laboratory biomarker analysis
    • Other: quality-of-life assessment
    • Procedure: Magnetic Resonance Imaging
    • Procedure: Magnetic Resonance Spectroscopic Imaging
  • Experimental: Stratum II (T lymphocytes intracavitary)
    Patients receive IL13Rα2-specific, hinge-optimized, 41BB-costimulatory CAR/truncated CD19-expressing T lymphocytes via intracavitary catheter over 5-10 minutes weekly for 3 weeks. Beginning as early as 1 week later, patients may receive additional T cell infusions as long as patients continue to remain eligible and there is product available. Patients who progress on intracavitary or intratumoral administration may move to intraventricular catheter for the optional infusions.
    Interventions:
    • Biological: IL13Rα2-specific, hinge-optimized, 41BB-costimulatory CAR/truncated CD19-expressing Autologous T lymphocytes
    • Other: laboratory biomarker analysis
    • Other: quality-of-life assessment
    • Procedure: Magnetic Resonance Imaging
    • Procedure: Magnetic Resonance Spectroscopic Imaging
  • Experimental: Stratum III (T lymphocytes intraventricular)
    Patients receive IL13Rα2-specific, hinge-optimized, 41BB-costimulatory CAR/truncated CD19-expressing T lymphocytes via intraventricular catheter over 5-10 minutes weekly for 3 weeks. Beginning as early as 1 week later, patients may receive additional T cell infusions as long as patients continue to remain eligible and there is product available.
    Interventions:
    • Biological: IL13Rα2-specific, hinge-optimized, 41BB-costimulatory CAR/truncated CD19-expressing Autologous T lymphocytes
    • Other: laboratory biomarker analysis
    • Other: quality-of-life assessment
    • Procedure: Magnetic Resonance Imaging
    • Procedure: Magnetic Resonance Spectroscopic Imaging
  • Experimental: Stratum IV (T lymphocytes intratumoral and intraventricular)
    Patients receive IL13Rα2-specific, hinge-optimized, 41BB-costimulatory CAR/truncated CD19-expressing T lymphocytes via intratumoral catheter and intraventricular catheter over 5 minutes weekly for 3 weeks. Beginning as early as 1 week later, patients may receive additional T cell infusions as long as patients continue to remain eligible and there is product available. Based on clinical response after the first 3 infusions, the study principal investigator may decide to continue with the optional infusions at either one or both sites (instead of requiring injections at both sites).
    Interventions:
    • Other: laboratory biomarker analysis
    • Other: quality-of-life assessment
    • Procedure: Magnetic Resonance Imaging
    • Procedure: Magnetic Resonance Spectroscopic Imaging
    • Biological: IL13Rα2-specific, hinge-optimized, 41BB-costimulatory CAR/truncated CD19-expressing Autologous T lymphocytes
  • Experimental: Stratum V (T lymphocytes intratumoral and intraventricular)
    Patients receive IL13 [EQ]BBzeta/truncated CD19[t]+ Tn/mem via intratumoral catheter and intraventricular catheter over 5 minutes weekly for 3 weeks. Beginning as early as 1 week later, patients may receive additional T cell infusions as long as patients continue to remain eligible and there is product available. Based on clinical response after the first 3 infusions, the study principal investigator may decide to continue with the optional infusions at either one or both sites (instead of requiring injections at both sites).
    Interventions:
    • Biological: Vaccine Therapy
    • Procedure: Magnetic Resonance Imaging
    • Procedure: Magnetic Resonance Spectroscopic Imaging
    • Other: Laboratory Biomarker Analysis
    • Other: Quality of Life Assessment
Brown CE, Alizadeh D, Starr R, Weng L, Wagner JR, Naranjo A, Ostberg JR, Blanchard MS, Kilpatrick J, Simpson J, Kurien A, Priceman SJ, Wang X, Harshbarger TL, D'Apuzzo M, Ressler JA, Jensen MC, Barish ME, Chen M, Portnow J, Forman SJ, Badie B. Regression of Glioblastoma after Chimeric Antigen Receptor T-Cell Therapy. N Engl J Med. 2016 Dec 29;375(26):2561-9. doi: 10.1056/NEJMoa1610497.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
92
44
May 2020
May 2020   (Final data collection date for primary outcome measure)

Inclusion Criteria:

SCREENING INCLUSION CRITERIA

  • Participant has a prior histologically-confirmed diagnosis of a grade III or IV glioma, or has a prior histologically-confirmed diagnosis of a grade II glioma and now has radiographic progression consistent with a grade III or IV malignant glioma (MG) after completing standard therapy
  • Radiographic evidence of progression/recurrence of the measurable disease more than 12 weeks after the end of the initial radiation therapy
  • Karnofsky performance status (KPS) >= 60%
  • Life expectancy > 4 weeks
  • 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
  • COH Clinical Pathology confirms IL13R alpha 2+ tumor expression by immunohistochemistry (>= 20%, 1+)
  • All research participants must have the ability to understand and the willingness to sign a written informed consent

ELIGIBILITY TO PROCEED WITH PBMC COLLECTION:

  • Research participant must not require more than 2 mg TID of Dexamethasone on the day of PBMC collection
  • Research participant must have appropriate venous access
  • At least 2 weeks must have elapsed since the research participant received his/her last dose of prior chemotherapy or radiation

ELIGIBILITY TO PROCEED WITH RICKHAM PLACEMENT:

  • Creatinine < 1.6 mg/dL
  • White blood cell (WBC) > 2,000/dl
  • Absolute neutrophil count (ANC) > 1,000
  • Platelets >= 100,000/dl
  • International normalized ratio (INR) < 1.3
  • Bilirubin < 1.5 mg/dL
  • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < 2.5 x upper limits of normal
  • An interval of at least 12 weeks must have elapsed since the completion of initial radiation therapy
  • At least 6 weeks since the completion of a nitrosourea-containing chemotherapy regimen
  • At least 23 days since the completion of Temodar and/or 4 weeks for any other non-nitrosourea-containing cytotoxic chemotherapy regimen; if a patient's most recent treatment was with a targeted agent only, and s/he has recovered from any toxicity of this targeted agent, then a waiting period of only 2 weeks is needed from the last dose and the start of study treatment, with the exception of bevacizumab where a wash out period of at least 4 weeks is required before starting study treatment

ELIGIBILITY FOR ENROLLMENT AND TO PROCEED WITH CAR T CELL INFUSION:

  • Research participant has a released cryopreserved T cell product
  • Research participant does not require supplemental oxygen to keep saturation greater than 95% and/or does not have presence of any radiographic abnormalities on chest x-ray that are progressive
  • Research participant does not require pressor support and/or does not have symptomatic cardiac arrhythmias
  • Research participant does not have a fever exceeding 38.5° Celsius (C); there is an absence of positive blood cultures for bacteria, fungus, or virus within 48-hours prior to T cell infusion and/or there aren't any indications of meningitis
  • Serum total bilirubin does not exceed 2 x normal limit
  • Transaminases does not exceed 2 x normal limit
  • Serum creatinine =< 1.8 mg/dL
  • Research participant does not have uncontrolled seizure activity following surgery prior to starting the first T cell dose
  • Platelet count must be >= 100,000; however, if platelet level is between 75,000-99,000, then T-cell infusion may proceed after platelet transfusion is given and the post transfusion platelet count is >= 100,000
  • Research participants must not require more than 2 mg thrice daily (TID) of dexamethasone during T cell therapy

Exclusion Criteria:

SCREENING EXCLUSION CRITERIA

  • Research participant requires supplemental oxygen to keep saturation greater than 95% and the situation is not expected to resolve within 2 weeks
  • Research participant requires pressor support and/or has symptomatic cardiac arrhythmias
  • Research participant requires dialysis
  • Research participant has uncontrolled seizure activity and/or clinically evident progressive encephalopathy
  • Failure of research participant to understand the basic elements of the protocol and/or the risks/benefits of participating in this phase I study; a legal guardian may substitute for the research participant
  • Research participants with any non-malignant intercurrent illness which is either poorly controlled with currently available treatment, or which is of such severity that the investigators deem it unwise to enter the research participant on protocol shall be ineligible
  • Research participants with any other active malignancies
  • Research participants being treated for severe infection or who are recovering from major surgery are ineligible until recovery is deemed complete by the investigator
  • Research participants with any uncontrolled illness including ongoing or active infection; research participants with known active hepatitis B or C infection; research participants with any signs or symptoms of active infection, positive blood cultures or radiological evidence of infections
  • Research participants who have confirmed HIV positivity within 4 weeks of screening
  • Subjects, who in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study
Sexes Eligible for Study: All
12 Years to 75 Years   (Child, Adult, Older Adult)
No
United States
 
 
NCT02208362
13384
NCI-2014-01488 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
13384 ( Other Identifier: City of Hope Medical Center )
R01FD005129 ( U.S. FDA Grant/Contract )
Yes
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Not Provided
City of Hope Medical Center
City of Hope Medical Center
  • National Cancer Institute (NCI)
  • Gateway for Cancer Research
  • Mustang Bio, Inc.
  • California Institute for Regenerative Medicine (CIRM)
Principal Investigator: Behnam Badie, MD City of Hope Medical Center
City of Hope Medical Center
January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP