Ignite Creation Date:
2024-05-06 @ 8:17 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06326008
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-28
First Post:
2024-03-10
Brief Title:
Safety Tolerability and Pharmacokinetics of Donor-derived CD19 CAR Therapy Bridged Allo-HSCT and Sequential Donor-derived CD22 CAR Therapy for rr B-ALL a Clinical Trial
Sponsor:
Beijing GoBroad Hospital
Organization:
Beijing GoBroad Hospital
Study Overview
Official Title:
Safety Tolerability and Pharmacokinetics of Donor-derived CD19 CAR Therapy Bridged Allogeneic Haematopoietic Stem Cell Transplantation and Sequential Donor-derived CD22 CAR Therapy in Refractory or Relapsed B Cell Acute Lymphoblastic Leukemia a Clinical Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is an investigator-initiated single-arm open-label non-randomised phase I clinical study The objective of this trial is to evaluate the safety tolerability and pharmacokinetics of donor-derived CD19 CAR Therapy bridged Allo-HSCT and sequential donor-derived CD22 CAR Therapy for rr B-ALL and to explore the efficacy of this therapy preliminarily The primary endpoints are incidence and type of dose-limiting toxicity DLT within 28 days ie 43 days after donor-derived CD19 CAR T-cell infusion after donor-derived CD19 CAR T-cell therapy bridged allogeneic haematopoietic stem cell transplantation total number incidence and severity of adverse events from donor-derived CD19 CAR T cell infusion back to 30 days after donor-derived CD22 CAR T cell infusion ie within 120 days of donor-derived CD19 CAR T cell infusion The secondary endpoints are total number incidence and severity of adverse events from 120 days to 2 years after donor-derived CD19 CAR T-cell infusion ORRCRCRi on days 45 90 120 duration of responseDOR event-free survivalEFS overall survivalOS pharmacokinetics characteristics The trial plan to enroll 312 cases in dose escalation phase and 36 cases in dose expansion phase
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None