Clinical Trial Details
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[Information provided by: ClinicalTrials.gov, which provides patients, family members, and members of the public easy and free access to information on clinical studies for a wide range of diseases and conditions.]

NCT02209376 : Pilot Study of Autologous T Cells Redirected to EGFRVIII-With a Chimeric Antigen Receptor in Patients With EGFRVIII+ Glioblastoma
PhaseN/A
AgesMin: 18 Years Max: N/A
Eligibility
Inclusion Criteria:

- Pathological criteria: Glioblastoma (GBM) that is histologically confirmed by
pathology review of surgically resected tissue.

- Tumor cells from resected tissue must be available for EGFRvIII testing. Patients who
have previously been treated with an EGFRvIII-targeted therapy and recurred, must
have a tumor sample obtained after their recurrence available for EGFRvIII testing.

- Age greater than 18 years 4. If the patient is on dexamethasone, the anticipated dose
must be 4 mg/day or less for at least 5 days prior to apheresis.

- ECOG performance status of 0 or 1 6. Documented negative serum HCG for female
patients of child-bearing potential.

- Participants with adequate organ function as measured by:

- White blood count greater than or equal to 2500/mm^3; platelets greater than or
equal to 100,000/mm^3, hemoglobin greater than or equal to 9.0 g/dL; without
transfusion or growth factor support

- AST, ALT, GGT, LDH, alkaline phosphatase within 2.5 x upper normal limit, and
total bilirubin less than or equal to 2.0 mg/dL

- Serum creatinine less than or equal to 1.5 x upper limit of normal

- Coagulation tests PT and PTT have to be within normal limits, unless the patient
has been therapeutically anti-coagulated for previous venous thrombosis.

- Provide voluntary informed consent for Tissue Screening and Apheresis Inclusion
Criteria Step 2:

1. Subject met all Step 1 Eligibility Criteria.

2. Tumor cells test positive for EGFRvIII expression (by RT-PCR, next generation
sequencing, or immunohistochemistry) and a CART EGFRvIII product has been
manufactured and formulated. Patients who have previously been treated with an
EGFRvIII-targeted therapy and recurred are only eligible if a tumor sample
obtained after their recurrence tests positive for EGFRvIII.

3. Stage of disease:

- Cohort 1: Patients with first relapse of previously diagnosed primary
glioblastoma. Recurrence may be determined by imaging and clinical criteria
alone.

- Cohort 2: Patients with newly diagnosed glioblastoma with a less than 95%
resection or greater than or equal to 1 cm^3 of residual disease on the
post-operative MRI (typically post-operative day 1).

4. If the patient is on dexamethasone, the dose must be 4 mg/day or less prior to
CART-EGFRvIII infusion.

5. It is anticipated that all patients in Cohort 2 will have completed standard of
care external beam radiotherapy and chemotherapy with temozolomide (TMZ) at the
time of the pre-infusion safety visit.

6. Life expectancy less greater than 3 months

7. ECOG performance status of 0 or 1.

8. Documented negative serum HCG for female patients of child-bearing age.

9. Participants with adequate organ function as measured by:

- White blood count greater than or equal to 2500/mm^3; platelets greater
than or equal to 100,000/mm^3, hemoglobin greater than or equal to 9.0
g/dL; without transfusion or growth factor support

- AST, ALT, GGT, LDH, alkaline phosphatase within 2.5 x upper normal limit,
and total bilirubin less than or equal to 2.0 mg/dL

- Serum creatinine less than or equal to 1.5 x upper limit of normal

- Coagulation tests PT and PTT have to be within normal limits, unless the
patient has been therapeutically anti-coagulated for previous venous
thrombosis.

- Adequate cardiac function (greater than EF 55%)

10. Provide voluntary informed consent for study treatment.

11. Female subjects of reproductive potential must agree to use a reliable method of
contraception.

Exclusion Criteria Step 1:

- Female subjects of reproductive potential who are pregnant or lactating. Female study
participants of reproductive potential must have a negative serum pregnancy test as
part of Step 1 eligibility confirmation.

- Uncontrolled active infection.

- Active or latent chronic hepatitis B [detectable hepatitis B surface antigen (HBsAg)]
or active hepatitis C (positive serology [HCV Ab]) infection.

- HIV infection.

- Previous treatment with any gene therapy products.

- Known addiction to alcohol or illicit drugs.

- History of allergy or hypersensitivity to study product excipients (human serum
albumin, DMSO, and Dextran 40)

Exclusion Criteria Step 2:

- Female subjects of reproductive potential who are pregnant or lactating. Female study
participants of reproductive potential must have a negative serum pregnancy test
within two weeks prior to CART-EGFRvIII cell infusion. The safety of this therapy on
unborn children is not known.

- Uncontrolled active infection.

- Use of immunosuppressive agents such as cyclosporine, MMF, tacrolimus, or rapamycin
within 4 weeks of enrollment on Step 2.

- A minimal dose of corticosteroid (dexamethasone up to 4 mg/day) is permitted. Recent
or current use of inhaled steroids is not exclusionary.

- Previous treatment with any gene therapy products.

- Subjects or their physicians anticipate use of any of the following concurrent
treatment or medications including: a. Radiosurgery (except for the Standard of Care
Fractionated External Radiation therapy is a part of the protocol regimen in Cohort
2) b. Chemotherapy (except for the Standard of Care Temozolomide therapy in Cohort 2)
c. Interferon (e.g. Intron-A®) d. Allergy desensitization injections e. Any ongoing
investigational therapeutic medication. f. Bevacizumab

- Participants who have another cancer diagnosis with history of visceral metastases at
the time of pre-entry evaluation. The following diagnoses are examples that will be
allowed:

- squamous cell cancer of the skin without known metastasis

- basal cell cancer of the skin without known metastasis

- carcinoma in situ of the breast (DCIS or LCIS)

- carcinoma in situ of the cervix

- prostate cancer with only PSA recurrence

- any cancer that has not required systemic therapy (other than hormonal
therapies) for the past three (3) years.

- Any uncontrolled active medical disorder that would preclude participation as
outlined.

- Unstable angina and/or myocardial infarction within 6 months prior to screening

- Known addiction to alcohol or illicit drugs.

- History of allergy or hypersensitivity to study product excipients (human serum
albumin, DMSO, and Dextran 40)
LinksPermanent Link to THIS page: https://virtualtrials.com/nct/display1trial.cfm?nct=NCT02209376      |      Link to official Clinicaltrials.gov listing
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