Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06617286
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-09
Brief Title:
CD30 CAR T-cells Post AutoHSCT for Poor-risk Hodgkin Lymphoma
Sponsor:
None
Organization:
None
Study Overview
Official Title:
MAC-CAR a Phase 1BII Trial of Myeloablative Conditioning and Autologous Stem Cell Transplantation Followed by Autologous CD30 CAR T Cells in Children Adolescents and Young Adults with Poor-Risk Classical Hodgkin Lymphoma cHL
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:
Patients with poor risk classical Hodgkin Lymphoma cHL will undergo myeloablative chemotherapy MAC with autologous stem cell transplantation AutoHSCT and subsequently receive autologous CD30 CAR T-cells
Detailed Description:
Eligible patients will be screened for study entry and proceed to cell procurement at local sites with collection of peripheral blood mononuclear cells PBMC for CD30 CAR T-cell manufacturing at UNC Patients will then have autologous stem cells collected PBSC and stored for future AutoHSCT
After another screening for MACAutoHSCT patients who meet criteria will receive BEAM conditioning followed by AutoHSCT About 21-42 day after the autologous stem cell infusion patients will receive their autologous CD30 CAR T-cell infusion if they meet subsequent pre CD30 CAR T-cell eligibility criteria
After another screening for MACAutoHSCT patients who meet criteria will receive BEAM conditioning followed by AutoHSCT About 21-42 day after the autologous stem cell infusion patients will receive their autologous CD30 CAR T-cell infusion if they meet subsequent pre CD30 CAR T-cell eligibility criteria
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