NCT06756451

This Study is a FIH Study Which is Required to Understand the PK Characteristics, MTD, RP2D and Safety Profile.

A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of RJK-RT2831 Injection in Patients With Hematologic Malignancies.

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 71 (estimated)
• Sponsor: Nanjing RegeneCore Biotech Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 74 Years
• Healthy volunteers: Not accepted

Summary

This study is a first-in-human (FIH) study which is required to understand the safety, tolerability, pharmacokinetics and preliminary efficacy of RJK-RT2831 injection in patients with hematologic malignancies

Detailed description

This is the first-in-human, Phase 1, open-label, multicenter, dose-escalation and dose expansion phase study to investigate the safety, Tolerability, pharmacokinetics and preliminary efficacy of RJK-RT2831 injection in patients with hematologic malignancies. About 70 subjects with malignant blood tumors will be recruited. The specific tumor type will be determined based on the results of the Phase Ia trial and may be expanded to other malignant blood tumor types.The primary goal of the study is to assess the safety, tolerability, maximum tolerated dose (MTD),determine the recommended doses for expansion (RDEs) and recommended phase 2 dose (RP2D) in patients with hematologic malignancies.

Conditions

• Hematologic Malignancies

Interventions

Type	Name	Description
DRUG	RJK-RT2831 dose-escalation phase Ia	there are seven doses(1mg-160mg) in this part. The subjects will receive RJK-RT2831 injection twice a week by intravenous push or intravenous infusion for 4 weeks until the end of one dosing cycle (28 days). After one dosing cycle, if the subject tolerates, the subject will continue to receive treatment until the researcher believes that the subject no longer benefits, or the subject has disease progression, unacceptable toxicity, withdraws informed consent, dies, is lost to follow-up, or starts new anti-tumor treatment (whichever occurs first).
DRUG	RJK-RT2831 Dose Expansion Phase Ib	there are four doses in this part. The subjects will be randomized in a 1:1 ratio to receive one dose level of RJK-RT2831 intravenous infusion twice a week for 4 weeks until the end of one dosing cycle (28 days).After one dosing cycle, if the subject tolerates, the subject will continue to receive treatment until the researcher believes that the subject no longer benefits, or the subject has disease progression, unacceptable toxicity, withdraws informed consent, dies, is lost to follow-up, or starts new anti-tumor treatment (whichever occurs first).

Timeline

• Start date: 2025-03-25
• Primary completion: 2028-04-08
• Completion: 2028-07-14
• First posted: 2025-01-03
• Last updated: 2026-01-30

Locations

16 sites across 1 country: China

Regulatory

• FDA-regulated drug study