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:
2025-12-24 @ 9:40 PM
Ignite Modification Date:
2025-12-24 @ 9:40 PM
NCT ID:
NCT03635632
Eligibility Criteria:
Procurement Inclusion Criteria:
1. Evaluable neuroblastoma with persistent or relapsed disease
1. Recurrent disease following completion of aggressive multi-drug frontline therapy.
2. Progressive disease during aggressive multi-drug frontline therapy.
3. Primary resistant/refractory disease (less than partial response by INRC) detected at the conclusion of at least 4 cycles of aggressive multi-drug induction chemotherapy on or according to a standard high-risk treatment protocol
OR Relapsed or refractory osteosarcoma not responsive to standard treatment
OR Patients diagnosed with GD2 positive metastatic uveal melanoma and progressed after at least one prior systemic treatment
OR GD2 positive breast cancer with metastatic or locally recurrent unresectable breast cancer currently progressive after at least two prior lines of therapy in the advanced setting. Patients with HER2+ disease must have failed two or more different anti-HER2 agents.
OR Patients with other relapsed or refractory solid tumors not responsive to standard treatment with confirmed expression of GD2 by immunohistochemistry testing.
2. Life expectancy of at least 12 weeks
3. Karnofsky/Lansky score of 50% or greater
4. Absence of human anti-mouse antibodies (HAMA) prior to enrollment (only in patients that have been previously treated with murine antibodies or testing pending)
5. Informed consent and assent (as applicable) obtained from parent/guardian and child
6. Greater than 1 and less than 75 years of age
Treatment Inclusion Criteria:
1. Neuroblastoma with persistent or relapsed disease
1. Recurrent disease following completion of aggressive multi-drug frontline therapy.
2. Progressive disease during aggressive multi-drug frontline therapy.
3. Primary resistant/refractory disease (less than partial response by INRC) detected at the conclusion of at least 4 cycles of aggressive multi-drug induction chemotherapy on or according to a standard high-risk treatment protocol.
OR Relapsed or refractory osteosarcoma not responsive to standard treatment
OR Patients diagnosed with GD2 positive metastatic uveal melanoma and progressed after at least one prior systemic treatment
OR GD2 positive breast cancer with metastatic or locally recurrent unresectable breast cancer currently progressive after at least two prior lines of therapy in the advanced setting. Patients with HER2+ disease must have failed two or more different anti-HER2 agents.
OR Patients with other relapsed or refractory solid tumors not responsive to standard treatment with confirmed expression of GD2 by immunohistochemistry testing.
2. Life expectancy of at least 12 weeks
3. Karnofsky/Lansky score of 50% or greater
4. Patients must have an ANC ≥ 500, platelet count ≥ 20,000
5. Pulse Ox ≥ 90% on room air
6. AST and ALT less than 5 times the upper limit of normal (less than 10 times upper normal if uveal melanoma with metastatic liver disease)
7. Total bilirubin less than 3 times the upper limit of normal
8. Serum creatinine less than 3 times upper limit of normal. Creatinine clearance is needed for patients with creatinine greater than 1.5 times upper limit of normal.
9. At least 4 weeks from completion and recovered from acute effects of all prior chemotherapy. If some effects of therapy have become chronic (i.e., treatment associated thrombocytopenia), the patient must be clinically stable and meet all other eligibility criteria. Maintenance therapy with non-investigational oral antineoplastic drugs is allowed up to 48 hours prior to infusion.
10. Absence of human anti-mouse antibodies (HAMA) prior to enrollment for patients who have received prior therapy with murine antibodies
11. Patients must have autologous activated T-cells with ≥ 20% expressing GD2.CAR
12. Informed consent and assent (as applicable) obtained from parent/guardian and child
13. Greater than 1 and less than 75 years of age
Procurement Exclusion Criteria:
1. History of hypersensitivity to murine protein containing products (patients who have undergone desensitization and successful re-challenge without hypersensitivity reaction are eligible)
2. Active autoimmune disease (requiring immunosuppressive treatment in the past 6 months)
3. Primary brain tumor or known brain metastases (on evaluation by MIBG and/or PET if applicable, CT/MRI/LP not required)
Treatment Exclusion Criteria
1. Currently receiving other investigational drugs.
2. Received any investigational immunotherapies or checkpoint inhibitors within 6 weeks. Immunotherapies include adoptive cell therapies, gene therapies, and tumor vaccines.
3. History of hypersensitivity to murine protein containing products (patients who have undergone desensitization and successful re-challenge without hypersensitivity reaction are eligible).
4. History of cardiomegaly or bilateral pulmonary infiltrates on chest radiograph or CT. However, patients with cardiomegaly on imaging may be enrolled if they have an assessment of cardiac function (i.e., ECHO or MUGA) within 3 weeks of starting protocol therapy that is within acceptable limits (LVSF\>28% or LVEF\>50%). Additionally, patients with bilateral pulmonary infiltrates on imaging may be enrolled if the lesions are not consistent with active neuroblastoma (i.e., negative on functional imaging with PET or MIBG, or by pathologic assessment) or not bulky in other diseases (\< 5 cm for each lesion) and patient meet FiO2 criteria (\>90% on room air). Baseline pulmonary function testing is required in patients with bilateral pulmonary infiltrates (except young children unable to undergo testing). Patients with poor lung function based on PFT testing (Patients with FEV 1, FVC and DLCO/diffusion capacity \< 50%) will not be eligible for treatment on protocol. Patients with intermediate function (FEV 1, FVC and DLCO/diffusion capacity ≥ 50% and \< 70% predicted) will require assessment by a pulmonologist prior to treatment.
5. Evidence of tumor potentially causing airway obstruction
6. Patients must not be pregnant, lactating, or unwilling to use birth control
7. Patients must not be currently receiving immunosuppressive drugs such as corticosteroids (prednisone dose of \> 0.25 mg/kg/day or equivalent), tacrolimus or cyclosporine
8. Active autoimmune disease (requiring immunosuppressive treatment in the past 6 months)
9. Primary brain tumor or known brain metastases (on evaluation by MIBG and/or PET if applicable, CT/MRI/LP not required)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
1 Year
Maximum Age:
74 Years
Study:
NCT03635632
Study Brief:
Protocol Section:
NCT03635632