Ignite Creation Date:
2025-12-24 @ 11:48 PM
Ignite Modification Date:
2025-12-25 @ 9:42 PM
Study NCT ID:
NCT07245251
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-11-24
First Post:
2025-11-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
To Evaluate the Safety, Tolerability, and Preliminary Antitumor Activity of STR-P004
Sponsor:
Starna Therapeutics
Organization:
Study Overview
Official Title:
An Early-Phase Clinical Study Evaluating the Safety and Clinical Efficacy of STR-P004 in Subjects With Relapsed/Refractory CD19-Positive Acute Lymphoblastic Leukemia
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-11
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 a single-arm, single-center, open-label, multiple-dose, dose-escalation early clinical study aimed at evaluating the safety, tolerability, pharmacokinetic characteristics, and preliminary antitumor activity of STR-P004 in subjects with relapsed/refractory CD19-positive acute lymphoblastic leukemia.
Detailed Description:
The study adopts a dose-escalation approach combining "accelerated titration" and "traditional 3+3" design. Five dose-escalation cohorts are planned within the dose range of AA mg/kg to BB mg/kg. The escalation follows a modified Fibonacci sequence (i.e., 2, 1.67, 1.5, 1.4, 1.33, 1.33… multiples), with faster escalation in the early stages to minimize patient exposure to ineffective doses and quickly reach the predicted effective dose range, followed by reduced escalation rates to ensure safety and explore efficacy.
Study Oversight
Has Oversight DMC:
False
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?: