RecruitingPhase 1

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

China71 participantsStarted 2025-03-25

Plain-language 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

Who can participate

Age range

18 Years – 74 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

5. Phase Ib tentatively includes patients with hematologic malignancies that meet the following criteria: relapsed or refractory AML subjects who have received at least one previous treatment and have failed to current standard treatments that provide clinical benefit, and MDS subjects who are diagnosed according to the 5th edition of the WHO Classification of Haematolymphoid Tumours-Myeloid and Histiocytic/Dendritic Neoplasms (Khoury et al., 2022) and are classified as high-risk or very-high-risk according to the Revised International Prognostic Scoring System (IPSS-R) (Greenberg et al., 2012). The specific tumor type will be determined based on the results of the Phase Ia trial and may be extended to other hematologic malignancies.
. Bone marrow function: white blood cell count ≤ 30×10\^9/L;
. Liver function: TBIL ≤ 1.5×ULN, TBIL ≤ 3×ULN if Gilbert's syndrome; ALT and AST ≤ 3 ×ULN;
. Renal function: creatinine clearance rate (CCr) \> 50 mL/min calculated according to the Cockcroft-Gault method
. Coagulation function: activated partial thromboplastin time (APTT) and prothrombin time (PT) ≤ 1.5×ULN.

Exclusion criteria

. Received cytotoxic chemotherapy (except hydroxyurea use for subjects with leukocytosis \>10,000 cells/mm3 or rapid disease progression), radiotherapy (except local palliative radiotherapy), immunotherapy, targeted therapy and other anti-tumor treatments within 14 days;
. Received adoptive cell therapy, such as autologous or donor natural killer cell or T lymphocyte infusions (e.g., chimeric antigen receptor-T cells), unless \> 60 days prior to the first dose of study treatment and treatment-related toxicities have resolved to at least Grade 1;

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

phase Ia and phase Ib: Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability

Timeframe: The summary of all AEs was dominated by adverse events that occurred during treatment, including any AE that occurred from the first administration of the study drug until 28 ± 7 days after the last administration.

phase Ia: Maximum Tolerated Dose (MTD)

Timeframe: From the first administration of the study drug until 28 days after the first dose

phase Ia: Recommended Doses for Expansion (RDEs)

Timeframe: From the first administration of the study drug until 28 ±7 days after the last administration and prior to the initiation of a new anti-tumor therapy

phase Ib: Recommended Phase II Dose (RP2D)

Timeframe: From the first administration of the study drug until 28 ±7 days after the last administration and prior to the initiation of a new anti-tumor therapy

Trial details

NCT IDNCT06756451

SponsorNanjing RegeneCore Biotech Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2028-04-08

Contact for this trial

Guo Qian

+86-025-58608860 guoqian@regenecore.com

View on ClinicalTrials.gov More Hematologic Malignancies trials

Who can participate

Age range

18 Years – 74 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

5. Phase Ib tentatively includes patients with hematologic malignancies that meet the following criteria: relapsed or refractory AML subjects who have received at least one previous treatment and have failed to current standard treatments that provide clinical benefit, and MDS subjects who are diagnosed according to the 5th edition of the WHO Classification of Haematolymphoid Tumours-Myeloid and Histiocytic/Dendritic Neoplasms (Khoury et al., 2022) and are classified as high-risk or very-high-risk according to the Revised International Prognostic Scoring System (IPSS-R) (Greenberg et al., 2012). The specific tumor type will be determined based on the results of the Phase Ia trial and may be extended to other hematologic malignancies.
. Bone marrow function: white blood cell count ≤ 30×10\^9/L;
. Liver function: TBIL ≤ 1.5×ULN, TBIL ≤ 3×ULN if Gilbert's syndrome; ALT and AST ≤ 3 ×ULN;
. Renal function: creatinine clearance rate (CCr) \> 50 mL/min calculated according to the Cockcroft-Gault method
. Coagulation function: activated partial thromboplastin time (APTT) and prothrombin time (PT) ≤ 1.5×ULN.

Exclusion criteria

. Received cytotoxic chemotherapy (except hydroxyurea use for subjects with leukocytosis \>10,000 cells/mm3 or rapid disease progression), radiotherapy (except local palliative radiotherapy), immunotherapy, targeted therapy and other anti-tumor treatments within 14 days;
. Received adoptive cell therapy, such as autologous or donor natural killer cell or T lymphocyte infusions (e.g., chimeric antigen receptor-T cells), unless \> 60 days prior to the first dose of study treatment and treatment-related toxicities have resolved to at least Grade 1;

What they're measuring

phase Ia and phase Ib: Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability

phase Ia: Maximum Tolerated Dose (MTD)

Timeframe: From the first administration of the study drug until 28 days after the first dose

phase Ia: Recommended Doses for Expansion (RDEs)

Timeframe: From the first administration of the study drug until 28 ±7 days after the last administration and prior to the initiation of a new anti-tumor therapy

phase Ib: Recommended Phase II Dose (RP2D)

Timeframe: From the first administration of the study drug until 28 ±7 days after the last administration and prior to the initiation of a new anti-tumor therapy