Status:
ACTIVE_NOT_RECRUITING
B7H3 CAR T Cell Immunotherapy for Recurrent/Refractory Solid Tumors in Children and Young Adults
Lead Sponsor:
Seattle Children's Hospital
Conditions:
Pediatric Solid Tumor
Germ Cell Tumor
Eligibility:
All Genders
Up to 26 years
Phase:
PHASE1
Brief Summary
This is a phase I, open-label, non-randomized study that will enroll pediatric and young adult research participants with relapsed or refractory non-CNS solid tumors to evaluate the safety, feasibilit...
Eligibility Criteria
Inclusion
- Participants age ≤ 26 years at the time of consent for study participation; the first 2 participants enrolled and treated with CAR T cells in both Arms A and B will be ≥ 15 years. and ≤ 26 years at time of consent for study participation
- Histologically diagnosed malignant, non-primary CNS solid tumor
- Evidence of refractory or recurrent disease
- Lansky or Karnofsky score ≥ 50
- Life expectancy ≥ 8 weeks
- Recovered from significant acute toxic effects of all prior chemotherapy, immunotherapy and radiotherapy
- If no apheresis product or usable T cell product is available, all chemotherapy has been discontinued ≥ 7 days prior to enrollment
- If no apheresis or usable T cell product is available, all biologic therapy has been discontinued ≥ 7 days prior to enrollment
- If no apheresis product or T cell product is available, all systemic corticosteroid therapy has been discontinued ≥ 7 days prior to enrollment (physiologic replacement dosing is allowed)
- If no apheresis product or usable T cell product is available, at least 3 half-lives or 30 days (whichever is shorter) from time of last dose of anti-tumor directed antibody therapy (including checkpoint inhibitor) at time of enrollment
- If no apheresis product or usable T cell product is available, at least 6 weeks post last dose of myeloablative therapy and autologous and/or allogeneic stem cell transplant, or non-myeloablative therapy and allogeneic stem cell transplant (all timed from stem cell infusion). Participants who receive autologous stem cell infusion following non-myeloablative therapy are eligible once all other eligibility requirements are met.
- If no apheresis product or usable T cell product is available, participants who have received genetically modified cell therapy must be at least 30 days from most recent cell infusion prior to enrollment
- If no apheresis product or usable T cell product is available, participants with neuroblastoma must be at least 12 weeks from I131 MIBG therapy.
- Adequate organ function
- Adequate laboratory values
- Participant is able to tolerate apheresis (including placement of temporary apheresis catheter, if necessary), or already has an apheresis product available for use in manufacturing.
- Participants of childbearing potential must agree to use highly effective contraception
Exclusion
- Presence of active malignancy other than primary malignant solid tumor diagnosis
- Current relevant CNS pathology
- Receiving external beam radiation therapy at time of enrollment
- Presence of active GVHD, or receiving immunosuppressive therapy for treatment or prevention of GVHD within 4 weeks prior to enrollment
- Participant is pregnant or breastfeeding
- Participant has presence of active severe infection
- Participant has presence of any condition that, in the option of an investigator, would prohibit the participant from undergoing treatment under this protocol
- Participant has primary immunodeficiency syndrome
- Unwilling or unable to provide consent/assent for participation in the study and 15 year follow up period
Key Trial Info
Start Date :
July 13 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2040
Estimated Enrollment :
68 Patients enrolled
Trial Details
Trial ID
NCT04483778
Start Date
July 13 2020
End Date
December 1 2040
Last Update
November 20 2025
Active Locations (1)
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1
Seattle Children's Hospital
Seattle, Washington, United States, 98105