Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06625190
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-01
Brief Title:
AlphaBeta T and B Cell Depletion With Zoledronic Acid for Solid Tumors
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Allogeneic Stem Cell Transplantation Utilizing AlphaBeta T Cell and CD19 B Cell Depletion With Zoledronic Acid in Combination to Treat Pediatric Adolescent and Young Adult Patients With RelapsedRefractory Solid Tumors
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Hematopoietic stem cell transplantation can cure patients with blood cancer and other underlying diseases αβ-T cell and B cell depletion has been introduced to decrease GVHD and PTLD and has demonstrated effectiveness for hematologic malignancies and non-malignant diseases additionally increasing the donor pool as to allow for haploidentical transplant to safely occur
While solid tumors can be highly chemotherapy sensitive many remain resistant and require multimodalities of treatment Immunotherapy has been developed to harness the immune system in fighting solid tumors though not all have targeted effects Some solid tumors are treated with autologous transplants however they do not always demonstrate an improved event free survival or overall survival There has been evidence of the use of allogeneic stem cell transplants to provide a graft versus tumor effect though studies remain limited
By utilizing αβ-T cell and B cell depletion for stem cell transplants and combining with zoledronic acid the immune system may potentially be harnessed and enhanced to provide an improved graft versus tumor effect in relapsedrefractory solid tumors and promote an improved event-free survival and overall survival
This study will investigate the safety of treatment with a stem cell graft depleted of αβ-T cell and CD19 B cells in combination with zoledronic acid in pediatric and young adult patients with select solid tumors as well as whether this treatment improves survival rates in these patients
While solid tumors can be highly chemotherapy sensitive many remain resistant and require multimodalities of treatment Immunotherapy has been developed to harness the immune system in fighting solid tumors though not all have targeted effects Some solid tumors are treated with autologous transplants however they do not always demonstrate an improved event free survival or overall survival There has been evidence of the use of allogeneic stem cell transplants to provide a graft versus tumor effect though studies remain limited
By utilizing αβ-T cell and B cell depletion for stem cell transplants and combining with zoledronic acid the immune system may potentially be harnessed and enhanced to provide an improved graft versus tumor effect in relapsedrefractory solid tumors and promote an improved event-free survival and overall survival
This study will investigate the safety of treatment with a stem cell graft depleted of αβ-T cell and CD19 B cells in combination with zoledronic acid in pediatric and young adult patients with select solid tumors as well as whether this treatment improves survival rates in these patients
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None