Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:24 AM
Ignite Modification Date:
2025-12-25 @ 12:24 AM
NCT ID:
NCT02624258
Eligibility Criteria:
Inclusion Criteria:
* Male or female subjects with HL with no available curative treatment options (such as autologous SCT) who have a limited prognosis (several months to \< 2 year survival) with currently available therapies will be enrolled.
* HL with biopsy-proven relapse or refractory disease who are unresponsive to or intolerant of at least one line of standard salvage therapy;
* Patients must have evaluable disease by radiologic imaging (FDG PET-CT or FDG PET-MRI) within 42 day of enrollment; evaluable includes both assessable and/or measurable disease
* Age 18 to 24 years. Patients ages 22-24 will only be enrolled if they are currently being treated at CHOP or another pediatric facility/oncologist.
* Expected survival \> 12 weeks at time of screening
* Adequate organ function defined as:
* Renal function defined as:
* Creatinine clearance or radioisotope GFR \> 60 mL/min/1.73 m2 OR
* Serum creatinine: \< 1.7mg/dL (male subjects) or \< 1.4mg/dL (female subjects)
* ALT \< 5 times the ULN for age
* Total Bilirubin \< 2.0 mg/dl
* Must have a minimum level of pulmonary reserve defined as ≤ Grade 1 dyspnea and pulse oxygenation \> 94% on room air
* Patients with relapsed disease after prior allogeneic SCT (myeloablative or non-myeloablative) will be eligible if they meet all other inclusion criteria and
* Have no active GVHD and require no immunosuppression
* Are more than 6 months from transplant 6) Karnofsky performance status ≥ 50 at screening
* Left Ventricular Shortening Fraction (LVSF) \> 28% confirmed by echocardiogram, or Left Ventricular Ejection Fraction (LVEF) \> 45% confirmed by echocardiogram or MUGA
* Signed written informed consent must be obtained prior to any study procedures
* Successful T cell test expansion (to be performed as part of inclusion criteria until 3 subjects meet all enrollment criteria)
Exclusion Criteria:
* Pregnant or lactating women. The safety of this therapy on unborn children is not known. Female study participants of reproductive potential must have a negative serum pregnancy test at enrollment. A urine pregnancy test will be performed within 48 hours before the RNA CART19 infusion.
* Uncontrolled active infection.
* Active hepatitis B or hepatitis C infection.
* Any uncontrolled active medical disorder that would preclude participation as outlined.
* HIV infection.
* Patients with known active CNS involvement by malignancy. Patients with prior CNS disease that has been effectively treated will be eligible providing treatment was \>4 weeks before enrollment
* Patients in complete remission with no evidence by radiologic imaging of disease.
* History of allergy to murine proteins
* History of allergy or hypersensitivity to study product excipients (human serum albumin, DMSO, and Dextran 40).
* Anti-CD20 monoclonal antibody therapy within the last 3 months, or absence of circulating B cells
* Unstable angina and/or myocardial infarction within 6 months prior to screening.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
24 Years
Study:
NCT02624258
Study Brief:
Protocol Section:
NCT02624258