A Study to Evaluate the Safety and Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of TJ011133 as Monotherapy and in Combination With Azacitidine (AZA) in Patients With Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS)
A Multicenter, Open-label, Phase 1/2a Study to Evaluate the Safety and Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of TJ011133 as Monotherapy and in Combination With Azacitidine (AZA) in Patients With Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS)
Sponsor: TJ Biopharma Co., Ltd.
Listed as NCT04202003, this PHASE1/PHASE2 trial focuses on Acute Myeloid Leukemia (AML) and Myelodysplastic Syndromes(MDS) and remains completed. Sponsored by TJ Biopharma Co., Ltd., it has been updated 18 times since 2020, reflecting substantial change activity. This study contributes to the evolving evidence base for cancer treatment protocols.
Status Flow
Change History
18 versions recorded-
Sep 2025 — Present [monthly]
Completed PHASE1/PHASE2
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Sep 2024 — Sep 2025 [monthly]
Completed PHASE1/PHASE2
-
Jul 2024 — Sep 2024 [monthly]
Completed PHASE1/PHASE2
Phase: PHASE1_PHASE2 → PHASE1/PHASE2
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May 2024 — Jul 2024 [monthly]
Completed PHASE1_PHASE2
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Mar 2024 — May 2024 [monthly]
Completed PHASE1_PHASE2
Status: Active Not Recruiting → Completed
▶ Show 13 earlier versions
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Feb 2024 — Mar 2024 [monthly]
Active Not Recruiting PHASE1_PHASE2
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Oct 2023 — Feb 2024 [monthly]
Active Not Recruiting PHASE1_PHASE2
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May 2023 — Oct 2023 [monthly]
Active Not Recruiting PHASE1_PHASE2
Status: Recruiting → Active Not Recruiting
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Sep 2022 — May 2023 [monthly]
Recruiting PHASE1_PHASE2
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Sep 2021 — Sep 2022 [monthly]
Recruiting PHASE1_PHASE2
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May 2021 — Sep 2021 [monthly]
Recruiting PHASE1_PHASE2
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Jan 2021 — May 2021 [monthly]
Recruiting PHASE1_PHASE2
-
Nov 2020 — Jan 2021 [monthly]
Recruiting PHASE1_PHASE2
-
Oct 2020 — Nov 2020 [monthly]
Recruiting PHASE1_PHASE2
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Sep 2020 — Oct 2020 [monthly]
Recruiting PHASE1_PHASE2
-
Jul 2020 — Sep 2020 [monthly]
Recruiting PHASE1_PHASE2
Status: Enrolling By Invitation → Recruiting
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Apr 2020 — Jul 2020 [monthly]
Enrolling By Invitation PHASE1_PHASE2
Status: Not Yet Recruiting → Enrolling By Invitation
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Jan 2020 — Apr 2020 [monthly]
Not Yet Recruiting PHASE1_PHASE2
First recorded
Eligibility Summary
No eligibility information available.
Contact Information
- TJ Biopharma Co., Ltd.
For direct contact, visit the study record on ClinicalTrials.gov .
Study Locations
Beijing, China , Changchun, China , Chongqing, China , Guangzhou, China , Guiyang, China , Hangzhou, China , Jinan, China , Kunming, China , Shanghai, China , Shenyang, China and 8 more locations