Humanized Anti-GD2 Antibody Hu3F8 and Allogeneic Natural... | NCT02650648

NCT02650648

Protocol Section

Identification Module

Results Section

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No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

ID	Type	Description	Link
5415	Other Identifier	OPD grant number

Status Module

Name	Class
Y-mAbs Therapeutics	INDUSTRY

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Humanized Anti-GD2 Antibody Hu3F8	Experimental	This is a phase I study to assess the safety and feasibility of combining HLA-mismatched (KIR ligand incompatible) NK cells with hu3F8 in high-risk NB patients. Following chemotherapy, patients will be treated in sequential groups with a minimum of 3 patients/ dose of NK cells. Three dose levels of NK cells, starting at dose level 1, will be evaluated in this treatment protocol. The goal dose for each dose level is the high boundary (e.g. 9.9x10^6/kg in level 1; 14.9x10^6/kg in level 2, etc), but a range is provided to allow for cases where the goal dose cannot be achieved.	Drug: cyclophosphamide Biological: NK cells Biological: hu3F8 Drug: rIL-2

Interventions

Name	Type	Description	Arm Group Labels	Other Names
cyclophosphamide	Drug	chemotherapy with intravenous (IV) cyclophosphamide 50mg/kg/day (for patients with body weight<70kg) or 1500mg/m^2/day (for patients with body weight ≥70kg) for two days (days -6 and -5).

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The number patient responses observed at each dose level	as defined by International NB Response Criteria. Disease status is defined by the International NB Response Criteria. Complete response/remission (CR): no evidence of disease. Very good partial response/remission (VGPR): >90% decrease in all disease parameters, except bone scan unchanged or improved; bone marrow must be free of disease. Partial response/remission: >50% decrease in all disease parameters, except bone scan unchanged or improved; no more than 1 positive bone marrow site. Mixed response: >50% decrease in >1 but not all disease markers. Stable disease: <50% decrease in all tumor markers. Progressive disease: new lesion, or >25 % increase in any disease marker.	2 years

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Diagnosis of NB as defined by international criteria,.e., histopathology (confirmed by the MSKCC Department of Pathology) or bone marrow metastases plus high urine catecholamine levels.
High-risk NB as defined by risk-related treatment guidelines1 and the International NB Staging System, i.e., stage 4 with (any age) or without (>365 days of age) MYCN amplification, MYCN-amplified stage 3 (unresectable; any age), or MYCN-amplified stage 4S.
Patients must have a history of tumor progression or persistent disease or failure to achieve complete response following standard therapy.
Patients must have evaluable (microscopic marrow metastasis, elevated tumor markers, positive MIBG or PET scans) or measurable (CT, MRI) disease documented after completion of prior systemic therapy.
Disease staging approximately within one month of treatment
Prior treatment with murine and hu3F8 is allowed. Patients with prior m3F8, hu3F8, ch14.18 or hu14.18 treatment must have a negative HAHA antibody titer. Human anti-mouse antibody (HAMA) positivity is allowed.
Eligible NK donor
Children and adults are eligible
Signed informed consent indicating awareness of the investigational nature of this program.

Donor Inclusion Criteria

Donor is blood-related and HLA-haploidentical to the recipient.
Donor has undergone serologic testing for transmissible diseases as per blood banking guidelines for organ and tissue donors. Tests include but are not limited to: Hepatitis B Surface Antigen, Hepatitis B Surface Antibody, Hepatitis B Core Antibody, Hepatitis C antibody, Epstein-Barr Virus Antibody, HIV, HTLV I and II, Varicella Zoster (Herpes Zoster), Herpes Simplex Antibody, Cytomegalovirus Antibodies, Syphilis (RPR profile) for adolescents and adults, measles for pediatric patients, West Nile Virus, Chagas screen, and Toxoplasma antibodies. Donor must have normal negative test results for HIV, HTLV I and II, and West Nile Virus. Donor exposure to other viral pathogens will be discussed on a case-by-case basis by investigators.
Donor must be able to undergo leukopheresis for total volume of 10-15 liters.
There is no age restriction for the donor.

Exclusion Criteria:

Patients with CR/VGPR disease
Existing severe major organ dysfunction, i.e., renal, cardiac, hepatic, neurologic, pulmonary, or gastrointestinal toxicity > grade 3 except for hearing loss, alopecia, anorexia, nausea, hyperbilirubinemia and hypomagnesemia from TPN, which may be grade 3
ANC should be >500/uL
Platelet count >75K/uL.
History of allergy to mouse proteins
Active life-threatening infection
Inability to comply with protocol requirements
Women who are pregnant or breast-feeding

Donor Exclusion Criteria:

Type	Date	Date Unknown
Release	Jun 9, 2026
Reset	Jul 2, 2026

ID	Term
D018241	Neuroectodermal Tumors, Primitive, Peripheral
D018242	Neuroectodermal Tumors, Primitive
D018302	Neoplasms, Neuroepithelial
D017599	Neuroectodermal Tumors

ID	Term
D003520	Cyclophosphamide
C000718263	naxitamab