Status:
ACTIVE_NOT_RECRUITING
Engineered Neuroblastoma Cellular Immunotherapy (ENCIT)-01
Lead Sponsor:
Seattle Children's Hospital
Collaborating Sponsors:
The Evan Foundation
Ben Towne Center for Childhood Cancer Research
Conditions:
Neuroblastoma
Ganglioneuroblastoma
Eligibility:
All Genders
18-26 years
Phase:
PHASE1
Brief Summary
Patients with recurrent or refractory neuroblastoma are resistance to conventional chemotherapy. For this reason, the investigators are attempting to use T cells obtained directly from the patient, wh...
Detailed Description
Upon meeting the eligibility requirements and enrolling on study, subjects will undergo apheresis to obtain the T cells for the generation of the CD171 CAR+ T cells. The T cells are isolated from the ...
Eligibility Criteria
Inclusion
- Prior diagnosis of NB or ganglioneuroblastoma either by histologic verification and/or demonstration of tumor cells in the bone marrow with increased catecholamine levels.
- Male or female subjects ≤ 26 years of age
- Diagnosis of high risk NB at initial diagnosis or if non-high risk at time of initial diagnosis must have had evidence of metastatic progression when \> 18 months of age.
- Measurable or evaluable disease
- Lansky or Karnofsky performance status score of ≥ 50
- Life expectancy of ≥ 8 weeks.
- Recovered from significant acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to enrollment onto this study.
- ≥ 7 days since last chemotherapy or biologic therapy administration
- No systemic corticosteroids (unless physiologic replacement dosing) within 7 days of enrollment. Topical Administration (e.g. inhaled or dermatologic) is allowed.
- ≥ 3 half-lives or 30 days from time of last dose of anti-tumor directed antibody therapy, whichever is shorter from time of enrollment
- ≥ 6 weeks from myeloablative therapy and autologous stem cell transplant (timed from stem cell infusion). Patients who received stem cell infusion following non-myelo-ablative therapy are eligible once they meet all other eligibility requirements. Patient must NOT have received a prior allogeneic hematopoietic stem cell transplant.
- No prior genetically modified cell therapy that is still detectable.
- Must not be receiving external beam radiation therapy at the time of study enrollment. ≥ 12 weeks from prior I131 MIBG therapy.
- Adequate organ function
- Adequate laboratory values
- Negative HIV antigen and antibody, Hepatitis B surface antigen and Hepatitis C antibody within 3 months prior to enrollment. For patients with positive Hepatitis C Ab, negative PCR testing must be documented in order to be eligible.
Exclusion
- History of relevant CNS pathology or current relevant CNS pathology (non-febrile seizure disorder requiring ongoing anti-epileptic medications, paresis, aphasia, cerebrovascular ischemia/hemorrhage, severe brain injuries, dementia, cerebellar disease, organic brain syndrome, psychosis, coordination or movement disorder). Patients may have CNS intracranial tumor.
- Pregnant or breast-feeding
- Unable to tolerate apheresis procedure including placement of temporary apheresis catheter if necessary
- Presence of active malignancy other than NB
- Presence of known intracranial metastatic neuroblastoma. Skull based disease with soft tissue extension is allowed.
- Presence of active severe infection
- Presence of any concurrent medical condition that, in the opinion of the protocol PI or designee, would prevent the patient from undergoing protocol-based therapy.
- Presence of a primary immunodeficiency/bone marrow failure syndrome
- Receiving any other anti-cancer agents or radiotherapy at the time of study entry
- Unwilling or unable to provide consent/assent for participation in the study and 15-year follow-up
Key Trial Info
Start Date :
November 25 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2038
Estimated Enrollment :
65 Patients enrolled
Trial Details
Trial ID
NCT02311621
Start Date
November 25 2014
End Date
November 1 2038
Last Update
May 28 2025
Active Locations (1)
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1
Seattle Children's Hospital
Seattle, Washington, United States, 98105