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IL13Ra2-CAR T Cells With or Without Nivolumab and Ipilimumab in Treating Patients With GBM

Primary Purpose

Recurrent Glioblastoma, Refractory Glioblastoma

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
IL13Ralpha2-specific Hinge-optimized 4-1BB-co-stimulatory CAR/Truncated CD19-expressing Autologous TN/MEM Cells
Ipilimumab
Nivolumab
Quality-of-Life Assessment
Questionnaire Administration
Sponsored by
City of Hope Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Recurrent Glioblastoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria Informed Consent and Willingness to Participate

  • 1. Documented informed consent of the participant and/or legally authorized representative. Assent, when appropriate, will be obtained per institutional guidelines.
  • 2. Agreement to allow the use of archival tissue from diagnostic tumor biopsies. If unavailable, exceptions may be granted with Study PI approval. Age Criteria, Performance status
  • 3. Ages ≥18 years
  • 4. KPS ≥ 60%, ECOG ≤ 2
  • 5. Life expectancy ≥ 4 weeks Nature of Illness and Illness Related Criteria
  • 6. Histologically confirmed diagnosis of WHO classification grade IV GBM, or has a prior histologicallyconfirmed diagnosis of a grade II or III glioma and now has radiographic progression consistent with a grade IV GBM after completing standard therapy.
  • 7. Relapsed/refractory disease: radiographic evidence of recurrence/progression of measurable disease after standard therapy, and ≥ 12 weeks after completion of front-line radiation therapy.
  • 8. COH Clinical Pathology confirms IL13Rα2+ tumor expression by IHC at the initial tumor presentation or recurrent disease (H-score > 50; reference Appendix B)
  • 9. Participants with a known history of congestive heart failure (CHF) or cardiac symptoms consistent with NYHA classification III-IV within 6 months prior to Day 1 of protocol treatment, cardiomyopathy, myocarditis, Myocardial Infarction (MI), exposure to cardiotoxic medications or with clinical history suggestive of the above must have an EKG and Echocardiogram (ECHO) performed within 42 days prior to registration and as clinically indicated while on treatment. Clinical Laboratory and Organ Function Criteria (To be performed within 14 days prior to leukapheresis unless otherwise stated.
  • 10. WBC > 2000 /dl (or ANC ≥ 1,000/mm3)
  • 11. Platelets ≥ 75,000/mm3
  • 12. Fasting Blood glucose within ULN
  • 13. Total bilirubin ≤ 1.5 ULN
  • 14. AST ≤ 2.5x ULN
  • 15. ALT ≤ 2.5x ULN
  • 16. Serum creatinine ≤1.6 mg/dL
  • 17. O2 saturation ≥ 95% on room air
  • 18. Seronegative for HIV Ag/Ab combo, Hepatitis C Ab*, active HBV (Surface Antigen Negative), Hepatitis A Virus IgM Antibody

    *If positive, Hepatitis C RNA quantitation must be performed.

  • 19. Women of childbearing potential (WOCBP): negative urine or serum pregnancy test If the urine test is positive or cannot be
  • 20. Agreement by females and males of childbearing potential* to use an effective method of birth control or abstain from heterosexual activity for the course of the study through at least 5 months after the last dose of nivolumab and/or 3 months after the last cycle of CAR T cells.

Exclusion Criteria Prior and concomitant therapies

  • 1. Prior CTLA-4, PD-1 or PD-L1 inhibitor therapy.
  • 2. Participant is steroid-dependent, requiring more than 6 mg of dexamethasone per day at the time of enrollment.
  • 3. Participant has not yet recovered from toxicities of prior therapy. Other illnesses or conditions
  • 4. History of or active autoimmune disease
  • 5. Uncontrolled seizure activity and/or clinically evident progressive encephalopathy
  • 6. History of allergic reactions attributed to compounds of similar chemical or biologic composition to study agent
  • 7. Active diarrhea
  • 8. Clinically significant uncontrolled illness
  • 9. Active infection requiring antibiotics
  • 10. Known history of immunodeficiency virus (HIV) or hepatitis B or hepatitis C infection
  • 11. Other active malignancy
  • 12. Females only: Pregnant or breastfeeding
  • 13. Any other condition that would, in the Investigator's judgment, contraindicate the subject's participation in the clinical study due to safety concerns with clinical study procedures. Noncompliance
  • 14. Prospective participants who, in the opinion of the Investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics).

Sites / Locations

  • City of Hope Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Arm I (nivolumab, ipilimumab, IL13Ralpha2 CAR T cells)

Arm II (nivolumab, IL13Ra2 CAR T cells)

Arm III (IL13Ra2 CAR T cells)

Arm Description

Patients receive nivolumab intravenously (IV) over 60 minutes and ipilimumab IV over 90 minutes on day -14. Patients then receive IL13Ralpha2 CAR T cells infusion over 5 minutes via Rickham catheter (ICV/intracranital ICT) every week and nivolumab IV over 30 minutes every other week. Treatment repeats weekly for up to 4 cycles in the absence of disease progression or unacceptable toxicity. After cycle 4, patients may receive additional CAR T cells weekly and nivolumab IV every other week or monthly at the discretion of the principal investigator and oncologist.

Patients receive IL13Ralpha2 CAR T cells infusion over 5 minutes via Rickham catheter (ICV/ICT) every week and nivolumab IV over 30 minutes every other week. Treatment repeats weekly for up to 4 cycles in the absence of disease progression or unacceptable toxicity. After cycle 4, patients may receive additional CAR T cells weekly and nivolumab IV every other week or monthly at the discretion of the principal investigator and oncologist.

Patients receive IL13Ralpha2 CAR T cells infusion over 5 minutes via Rickham catheter (ICV/ICT) every week. Treatment repeats weekly for up to 4 cycles in the absence of disease progression or unacceptable toxicity. After cycle 4, patients may receive additional CAR T cells weekly at the discretion of the principal investigator and oncologist.

Outcomes

Primary Outcome Measures

Incidence of adverse events
Will assess dose limiting toxicity and all toxicities. Toxicity is the primary endpoint and will be assessed using the National Cancer Institute (NCI)'s Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Rates and associated 95% Clopper and Pearson binomial confidence limits (95% confidence interval [CI]) will be estimated for participants' experiencing dose limiting toxicity (DLT) during neoadjuvant treatment period (DLT period 1), during adjuvant treatment period (DLT period 2), neo-adjuvant and adjuvant feasibility, as well as survival at 9 months. All toxicities and side effects will be summarized in tables by dose, time period, organ, and severity.
Dose-limiting toxicity (DLT)
A toxicity that causes side effects that are serious enough to prevent an increase in dose or level of that treatment.
Feasibility (neoadjuvant therapy)
As measured by the ability of patients receive ipilimumab/nivolumab (> 80% of the assigned doses) and undergo undergo surgery so that they can go on to receive the first dose of CAR T cells.
Feasibility (adjuvant therapy)
Defined as the ability of patients to complete 4 cycles of CAR T infusions (> 80% of the assigned dose) and 2 doses of nivolumab.
Overall Survival
The length of time from either the date of diagnosis or the start of treatment for a disease, such as cancer, that patients diagnosed with the disease are still alive.

Secondary Outcome Measures

T cell levels
Will assess chimeric antigen receptor (CAR) T and endogenous T cell levels and phenotype detected in tumor cyst fluid (TCF), peripheral blood (PB), and cerebral spinal fluid (CSF) (absolute number per ul by flow). Statistical and graphical methods will be used to describe persistence and expansion.
Cytokine levels in TCF, PB, and CSF
Statistical and graphical methods will be used to describe persistence and expansion.
Disease response
By Response Assessment in Neuro-Oncology (RANO) criteria with the need for Avastin as an additional indicator of progression.
Time to progression
Progression is defined by RANO with the need for Avastin as an additional indicator of progression.
Overall survival (OS)
Kaplan Meier methods will be used to estimate median OS and graph the results.
Quality of life (QOL)
Will 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 European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 and the domain scale and items scores from the Quality of Life Questionnaire Brian Tumor Patients 20. Will be estimated for each treatment arm.
Area under the curve (AUC) for CD3, IFNgamma, and IP-10 levels over time for the DLT evaluation period
A two-tailed two-sample Students T test with a 0.05 level of significance will be used to determine if the AUCs over the adjuvant treatment DLT period (DLT period 2) for CD3, IFNgamma, and IP-10 are higher in one arm over the other.
CAR T and endogenous cells detected in tumor tissue
By immunohistochemistry.
IL13Ralpha2 antigen expression levels in tumor tissue
By pathology H score.
PD-L1 levels on tumor cells
By flow cytometry
Biomathematical modeling of tumor growth
Will assess perfusion and growth parameters based on serial brain magnetic resonance imaging (MRI)s.
Progression free survival (PFS)
Kaplan Meier methods will be used to estimate median PFS and graph the results.

Full Information

First Posted
November 23, 2018
Last Updated
February 7, 2023
Sponsor
City of Hope Medical Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT04003649
Brief Title
IL13Ra2-CAR T Cells With or Without Nivolumab and Ipilimumab in Treating Patients With GBM
Official Title
A Phase 1 Study to Evaluate IL13Rα2-Targeted Chimeric Antigen Receptor (CAR) T Cells Combined With Checkpoint Inhibition for Patients With Resectable Recurrent Glioblastoma
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 2, 2019 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
City of Hope Medical Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This phase I trial studies the side effects and how well IL13Ralpha2-CAR T cells work when given alone or together with nivolumab and ipilimumab in treating patients with glioblastoma that has come back (recurrent) or does not respond to treatment (refractory). Biological therapies, such as IL13Ralpha2-CAR T cells, use substances made from living organisms that may attack specific glioma cells and stop them from growing or kill them. Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. It is not yet known whether giving IL13Ralpha2-CAR T cells and nivolumab together may work better in treating patients with glioblastoma.
Detailed Description
PRIMARY OBJECTIVES: I. To examine and describe the safety and feasibility of nivolumab plus ipilimumab as neoadjuvant therapy. (Arm 1) II. To examine and describe the safety and feasibility of IL13Ralpha2-CAR T cell plus nivolumab as adjuvant therapy. (Arms 1 and 2) III. To provide IL13Rα2-CAR T cell therapy for subjects who are unable to wait for randomization into Arms 1 and 2. This arm will provide additional safety data provided in COH IRB 13384 for the set dose schedule. (Arm 3) III. In arms determined to be safe and feasible, a selection design based on two Southwest Oncology Group (SWOG) two stage designs will be used to assess which arm(s) goes on for further study based on survival rate at 9 months. SECONDARY OBJECTIVES: I. Describe persistence, expansion and phenotype of endogenous and IL13Ralpha2-CAR CAR T cells in tumor cyst fluid (TCF), peripheral blood (PB), and cerebral spinal fluid (CSF). II. Describe cytokine levels (PB, TCF, CSF) over the study period for each arm. (Arm 1 or Arm 2). III. Estimate disease response rates. IV. Estimate time to progression. V. Estimate median overall survival (OS). VI. In study participants who have completed the adjuvant dose-limiting toxicity (DLT) period: VIa. 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-Core (QLQ-C)30 and EORTC QLQ Brain Cancer Patients (BN-20) survey scale, domain and item scores during and post treatment. VIb. Assess if the area under the curve (AUC) for CD3 T cells, IFNgamma and IP-10 for the DLT period is greater in one arm versus (vs.) the other. VII. In study participants who undergo an additional biopsy/resection or autopsy: VIIa. Evaluate CAR T cell persistence in the tumor tissue and the location of the CAR T cells with respect to the injection, and VIIb. Evaluate IL13Ralpha2 antigen and PD-L1 levels on tumor tissue pre and post CAR T cell therapy. VIII. Use biomathematical modeling of tumor growth to evaluate benefit of treatment. OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Patients receive nivolumab intravenously (IV) over 60 minutes and ipilimumab IV over 90 minutes on day -14. Patients then receive IL13Ralpha2 CAR T cells infusion over 5 minutes via Rickham catheter (intracranial intraventricular [ICV]/intracranial intratumoral [ICT]) every week and nivolumab IV over 30 minutes every other week. Treatment repeats weekly for up to 4 cycles in the absence of disease progression or unacceptable toxicity. After cycle 4, patients may receive additional CAR T cells weekly and nivolumab IV every other week or monthly at the discretion of the principal investigator and oncologist. ARM II: Patients receive IL13Ralpha2 CAR T cells infusion over 5 minutes via Rickham catheter (ICV/ICT) every week and nivolumab IV over 30 minutes every other week. Treatment repeats weekly for up to 4 cycles in the absence of disease progression or unacceptable toxicity. After cycle 4, patients may receive additional CAR T cells weekly and nivolumab IV every other week or monthly at the discretion of the principal investigator and oncologist. ARM III: Patients receive IL13Ralpha2 CAR T cells infusion over 5 minutes via Rickham catheter (intracranial intraventricular [ICV]/intracranial intratumoral [ICT]) every week. Treatment repeats weekly for up to 4 cycles in the absence of disease progression or unacceptable toxicity. After cycle 4, patients may receive additional CAR T cells weekly at the discretion of the principal investigator and oncologist. After completion of study treatment, patients are followed up at 30 days, 3, 6, and 12 months, and then annually for 15 years.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recurrent Glioblastoma, Refractory Glioblastoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm I (nivolumab, ipilimumab, IL13Ralpha2 CAR T cells)
Arm Type
Experimental
Arm Description
Patients receive nivolumab intravenously (IV) over 60 minutes and ipilimumab IV over 90 minutes on day -14. Patients then receive IL13Ralpha2 CAR T cells infusion over 5 minutes via Rickham catheter (ICV/intracranital ICT) every week and nivolumab IV over 30 minutes every other week. Treatment repeats weekly for up to 4 cycles in the absence of disease progression or unacceptable toxicity. After cycle 4, patients may receive additional CAR T cells weekly and nivolumab IV every other week or monthly at the discretion of the principal investigator and oncologist.
Arm Title
Arm II (nivolumab, IL13Ra2 CAR T cells)
Arm Type
Experimental
Arm Description
Patients receive IL13Ralpha2 CAR T cells infusion over 5 minutes via Rickham catheter (ICV/ICT) every week and nivolumab IV over 30 minutes every other week. Treatment repeats weekly for up to 4 cycles in the absence of disease progression or unacceptable toxicity. After cycle 4, patients may receive additional CAR T cells weekly and nivolumab IV every other week or monthly at the discretion of the principal investigator and oncologist.
Arm Title
Arm III (IL13Ra2 CAR T cells)
Arm Type
Experimental
Arm Description
Patients receive IL13Ralpha2 CAR T cells infusion over 5 minutes via Rickham catheter (ICV/ICT) every week. Treatment repeats weekly for up to 4 cycles in the absence of disease progression or unacceptable toxicity. After cycle 4, patients may receive additional CAR T cells weekly at the discretion of the principal investigator and oncologist.
Intervention Type
Biological
Intervention Name(s)
IL13Ralpha2-specific Hinge-optimized 4-1BB-co-stimulatory CAR/Truncated CD19-expressing Autologous TN/MEM Cells
Other Intervention Name(s)
IL13 [EQ]BBzeta/truncated CD19[t]+ Naive and Memory T Cells, IL13 [EQ]BBzeta/truncated CD19[t]+ TN/MEM Cells, IL13Ra2-specific-hinge-optimized-4-1BB-CAR/truncated CD19-expressing Autologous TN/MEM Lymphocytes
Intervention Description
Given ITV/ITC
Intervention Type
Biological
Intervention Name(s)
Ipilimumab
Other Intervention Name(s)
Anti-Cytotoxic T-Lymphocyte-Associated Antigen-4 Monoclonal Antibody, BMS-734016, MDX-010, MDX-CTLA4, Yervoy
Intervention Description
Given IV
Intervention Type
Biological
Intervention Name(s)
Nivolumab
Other Intervention Name(s)
BMS-936558, MDX-1106, NIVO, ONO-4538, Opdivo
Intervention Description
Given IV
Intervention Type
Other
Intervention Name(s)
Quality-of-Life Assessment
Other Intervention Name(s)
Quality of Life Assessment
Intervention Description
Ancillary studies
Intervention Type
Other
Intervention Name(s)
Questionnaire Administration
Intervention Description
Ancillary studies
Primary Outcome Measure Information:
Title
Incidence of adverse events
Description
Will assess dose limiting toxicity and all toxicities. Toxicity is the primary endpoint and will be assessed using the National Cancer Institute (NCI)'s Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Rates and associated 95% Clopper and Pearson binomial confidence limits (95% confidence interval [CI]) will be estimated for participants' experiencing dose limiting toxicity (DLT) during neoadjuvant treatment period (DLT period 1), during adjuvant treatment period (DLT period 2), neo-adjuvant and adjuvant feasibility, as well as survival at 9 months. All toxicities and side effects will be summarized in tables by dose, time period, organ, and severity.
Time Frame
Up to 15 years
Title
Dose-limiting toxicity (DLT)
Description
A toxicity that causes side effects that are serious enough to prevent an increase in dose or level of that treatment.
Time Frame
Up to 28 days
Title
Feasibility (neoadjuvant therapy)
Description
As measured by the ability of patients receive ipilimumab/nivolumab (> 80% of the assigned doses) and undergo undergo surgery so that they can go on to receive the first dose of CAR T cells.
Time Frame
Up to 14 days
Title
Feasibility (adjuvant therapy)
Description
Defined as the ability of patients to complete 4 cycles of CAR T infusions (> 80% of the assigned dose) and 2 doses of nivolumab.
Time Frame
Up to 28 days
Title
Overall Survival
Description
The length of time from either the date of diagnosis or the start of treatment for a disease, such as cancer, that patients diagnosed with the disease are still alive.
Time Frame
At 9 months
Secondary Outcome Measure Information:
Title
T cell levels
Description
Will assess chimeric antigen receptor (CAR) T and endogenous T cell levels and phenotype detected in tumor cyst fluid (TCF), peripheral blood (PB), and cerebral spinal fluid (CSF) (absolute number per ul by flow). Statistical and graphical methods will be used to describe persistence and expansion.
Time Frame
Up to 15 years
Title
Cytokine levels in TCF, PB, and CSF
Description
Statistical and graphical methods will be used to describe persistence and expansion.
Time Frame
Up to 15 years
Title
Disease response
Description
By Response Assessment in Neuro-Oncology (RANO) criteria with the need for Avastin as an additional indicator of progression.
Time Frame
Up to 15 years
Title
Time to progression
Description
Progression is defined by RANO with the need for Avastin as an additional indicator of progression.
Time Frame
Up to 15 years
Title
Overall survival (OS)
Description
Kaplan Meier methods will be used to estimate median OS and graph the results.
Time Frame
Up to 15 years
Title
Quality of life (QOL)
Description
Will 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 European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 and the domain scale and items scores from the Quality of Life Questionnaire Brian Tumor Patients 20. Will be estimated for each treatment arm.
Time Frame
Up to 15 years
Title
Area under the curve (AUC) for CD3, IFNgamma, and IP-10 levels over time for the DLT evaluation period
Description
A two-tailed two-sample Students T test with a 0.05 level of significance will be used to determine if the AUCs over the adjuvant treatment DLT period (DLT period 2) for CD3, IFNgamma, and IP-10 are higher in one arm over the other.
Time Frame
Up to 28 days
Title
CAR T and endogenous cells detected in tumor tissue
Description
By immunohistochemistry.
Time Frame
Up to 15 years
Title
IL13Ralpha2 antigen expression levels in tumor tissue
Description
By pathology H score.
Time Frame
Up to 15 years
Title
PD-L1 levels on tumor cells
Description
By flow cytometry
Time Frame
Pre- and post-therapy
Title
Biomathematical modeling of tumor growth
Description
Will assess perfusion and growth parameters based on serial brain magnetic resonance imaging (MRI)s.
Time Frame
Up to 15 years
Title
Progression free survival (PFS)
Description
Kaplan Meier methods will be used to estimate median PFS and graph the results.
Time Frame
Up to 15 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria Informed Consent and Willingness to Participate 1. Documented informed consent of the participant and/or legally authorized representative. Assent, when appropriate, will be obtained per institutional guidelines. 2. Agreement to allow the use of archival tissue from diagnostic tumor biopsies. If unavailable, exceptions may be granted with Study PI approval. Age Criteria, Performance status 3. Ages ≥18 years 4. KPS ≥ 60%, ECOG ≤ 2 5. Life expectancy ≥ 4 weeks Nature of Illness and Illness Related Criteria 6. Histologically confirmed diagnosis of WHO classification grade IV GBM, or has a prior histologicallyconfirmed diagnosis of a grade II or III glioma and now has radiographic progression consistent with a grade IV GBM after completing standard therapy. 7. Relapsed/refractory disease: radiographic evidence of recurrence/progression of measurable disease after standard therapy, and ≥ 12 weeks after completion of front-line radiation therapy. 8. COH Clinical Pathology confirms IL13Rα2+ tumor expression by IHC at the initial tumor presentation or recurrent disease (H-score > 50; reference Appendix B) 9. Participants with a known history of congestive heart failure (CHF) or cardiac symptoms consistent with NYHA classification III-IV within 6 months prior to Day 1 of protocol treatment, cardiomyopathy, myocarditis, Myocardial Infarction (MI), exposure to cardiotoxic medications or with clinical history suggestive of the above must have an EKG and Echocardiogram (ECHO) performed within 42 days prior to registration and as clinically indicated while on treatment. Clinical Laboratory and Organ Function Criteria (To be performed within 14 days prior to leukapheresis unless otherwise stated. 10. WBC > 2000 /dl (or ANC ≥ 1,000/mm3) 11. Platelets ≥ 75,000/mm3 12. Fasting Blood glucose within ULN 13. Total bilirubin ≤ 1.5 ULN 14. AST ≤ 2.5x ULN 15. ALT ≤ 2.5x ULN 16. Serum creatinine ≤1.6 mg/dL 17. O2 saturation ≥ 95% on room air 18. Seronegative for HIV Ag/Ab combo, Hepatitis C Ab*, active HBV (Surface Antigen Negative), Hepatitis A Virus IgM Antibody *If positive, Hepatitis C RNA quantitation must be performed. 19. Women of childbearing potential (WOCBP): negative urine or serum pregnancy test If the urine test is positive or cannot be 20. Agreement by females and males of childbearing potential* to use an effective method of birth control or abstain from heterosexual activity for the course of the study through at least 5 months after the last dose of nivolumab and/or 3 months after the last cycle of CAR T cells. Exclusion Criteria Prior and concomitant therapies 1. Prior CTLA-4, PD-1 or PD-L1 inhibitor therapy. 2. Participant is steroid-dependent, requiring more than 6 mg of dexamethasone per day at the time of enrollment. 3. Participant has not yet recovered from toxicities of prior therapy. Other illnesses or conditions 4. History of or active autoimmune disease 5. Uncontrolled seizure activity and/or clinically evident progressive encephalopathy 6. History of allergic reactions attributed to compounds of similar chemical or biologic composition to study agent 7. Active diarrhea 8. Clinically significant uncontrolled illness 9. Active infection requiring antibiotics 10. Known history of immunodeficiency virus (HIV) or hepatitis B or hepatitis C infection 11. Other active malignancy 12. Females only: Pregnant or breastfeeding 13. Any other condition that would, in the Investigator's judgment, contraindicate the subject's participation in the clinical study due to safety concerns with clinical study procedures. Noncompliance 14. Prospective participants who, in the opinion of the Investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Behnam Badie
Organizational Affiliation
City of Hope Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
City of Hope Medical Center
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Behnam Badie
Phone
626-256-4673
Ext
89393
Email
neurosurgerymail@coh.org
First Name & Middle Initial & Last Name & Degree
Behnam Badie

12. IPD Sharing Statement

Learn more about this trial

IL13Ra2-CAR T Cells With or Without Nivolumab and Ipilimumab in Treating Patients With GBM

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