NCT07003178

A Study to Evaluate the Safety and Clinical Efficacy of STR-P004

An Early Clinical Study to Evaluate the Safety and Clinical Efficacy of STR-P004 in Subjects With Relapsed/Refractory CD19-Positive B-Lymphocytic Non-Hodgkin's Lymphoma

• Status: Not Yet Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Starna Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is a single-arm, single-center, open-label, multiple-dose, dose-escalation early clinical study aimed at evaluating the safety, tolerability, and pharmacokinetic profile of STR-P004 in subjects with relapsed/refractory CD19-positive B-cell non-Hodgkin lymphoma, and preliminarily observing its antitumor activity.

Detailed description

This study employs a dose-escalation approach combining "accelerated titration" and "traditional 3+3". Within the dose range of xxmg/kg to xxxmg/kg, five dose-escalation cohorts are planned. The escalation follows a modified Fibonacci sequence (i.e., 2, 1.67, 1.5, 1.4, 1.33, 1.33 …… 1.33-fold increments). A faster escalation rate is used in the early phase to minimize patient exposure to ineffective doses and rapidly reach the predicted effective dose range, after which the escalation rate is reduced to ensure safety and explore efficacy. This study plans to enroll adult patients with B-cell non-Hodgkin's lymphoma (NHL). Enrolled patients will receive STR-P004 at the corresponding dose via intravenous infusion. Patients will receive weekly treatment doses starting from D1 for 4 consecutive weeks (D1, D8, D15, D22), with each 4-week period constituting a treatment cycle. Based on preliminary treatment results from Cycle 1, the investigator will decide whether to proceed with subsequent cycles, which will follow the same regimen as Cycle 1. The DLT observation period is 28 days (i.e., D1 to D28). If no DLT occurs or if no Grade ≥2 AE judged by the investigator to be related to the study drug and medically significant is observed, patients will be enrolled into the next dose group after the 28-day DLT observation period for the previous dose group is ended. During the accelerated titration phase, if a DLT or any Grade ≥2 AE judged by the investigator to be related to the study drug and medically significant occurs within 28 days, enrollment will switch to the "3+3" pattern.

Conditions

• Non Hodgkin Lymphoma

Interventions

Type	Name	Description
DRUG	STR-P004	An in vivo CART drug administered intravenously

Timeline

• Start date: 2025-06-01
• Primary completion: 2026-04-01
• Completion: 2027-05-01
• First posted: 2025-06-04
• Last updated: 2025-06-04

Locations

1 site across 1 country: China