Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06622694
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-30
Brief Title:
CD7 CAR T Cells RD13-02 in the Treatment of RelapsedRefractory Severe Aplastic Anemia
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Clinical Study of Safety Efficacy and Pharmacokinetics of Universal CD7 CAR T Cells RD13-02 in the Treatment of RelapsedRefractory Severe Aplastic Anemia
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
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:
This trial is exploratory research aimed at evaluating the safety tolerability pharmacokinetics pharmacodynamics and efficacy of RD13-02 a universal CD7 CAR T therapy in subjects with relapsedrefractory severe aplastic anemia SAA
Detailed Description:
This trial used a single-arm open-label and 33 dose-escalation design It is divided into two phases the dose escalation phase and the expansion phase The dose escalation and expansion phases each consisted of a screening period of up to 2 weeks a 7-day conditioning period a 28-day treatment period and a follow-up period to 6 months after the first infusion
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