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

PHASE1RecruitingINTERVENTIONAL
Enrollment

71

Participants

Timeline

Start Date

March 25, 2025

Primary Completion Date

April 8, 2028

Study Completion Date

July 14, 2028

Conditions
Hematologic Malignancies
Interventions
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).

Trial Locations (16)

110001

RECRUITING

The First Hospital of China Medical University, Shenyang

210009

RECRUITING

Zhongda Hospital Southeast University, Nanjing

215006

RECRUITING

The First Affiliated Hospital of Soochow University, Suzhou

230001

RECRUITING

The First Affiliated Hospital of USTC, Hefei

230601

RECRUITING

The Second Hospital of Anhui Medical University, Hefei

300020

RECRUITING

Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Tianjin

330006

RECRUITING

The First Affiliated Hospital of Nanchang University, Nanchang

450003

RECRUITING

Henan Cancer Hospital, Zhengzhou

510080

RECRUITING

Guangdong Provincial People's Hospital, Guangzhou

510515

RECRUITING

Southern Medical University Nanfang Hospital, Guangzhou

518020

RECRUITING

Shenzhen People's Hospital, Shenzhen

530021

RECRUITING

The First Affiliated Hospital of Guangxi Medical University, Nanning

541001

RECRUITING

The Affiliated Hospital of Guilin Medical University, Guilin

710061

RECRUITING

The First Affiliated Hospital of Xi 'an Jiaotong University, Xi'an

071000

RECRUITING

Affiliated Hospital of Hebei University, Baoding

063008

RECRUITING

Tangshan Central Hospital, Tangshan

All Listed Sponsors
lead

Nanjing RegeneCore Biotech Co., Ltd.

INDUSTRY