NCT07245251

To Evaluate the Safety, Tolerability, and Preliminary Antitumor Activity of STR-P004

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 11 (estimated)
• Sponsor: Starna Therapeutics · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acute Lymphobkastic Leukemia

Interventions

Type	Name	Description
DRUG	STR-P004	This study enrolls adult patients with B-cell acute lymphoblastic leukemia (B-ALL). Enrolled patients receive STR-P004 at the corresponding dose via intravenous infusion, administered four times

Timeline

• Start date: 2025-12-03
• Primary completion: 2026-11-02
• Completion: 2026-12-30
• First posted: 2025-11-24
• Last updated: 2025-11-24