To hear about similar clinical trials, please enter your email below
Trial Title:
A Study of QLF32101 in Patients With Acute Myeloid Leukemia and Myelodysplastic Syndrome
NCT ID:
NCT05703204
Condition:
Acute Myeloid Leukemia and Myelodysplastic Syndrome
Conditions: Official terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Preleukemia
Myelodysplastic Syndromes
Syndrome
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
QLF32101
Description:
The dose is given weekly and observed for 28 days(DLT observation period).Single agent
treatment.
Arm group label:
QLF32101
Summary:
This study aimed to evaluate the safety,tolerability and preliminary efficacy of QLF32101
administered intravenously and subcutaneously in patients with R/R, AML.
Detailed description:
This open label, first-in-human study consists of 2 parts. Part 1 consists of dose
escalation cohorts and Part 2 is expansion cohort.
The study population will include adult AML patients with relapse or refractory disease.
In addition, in Part 2 medium and high-risk MDS patients are eligible.
In Part 1, dose escalations cohorts are followed until dose-limiting toxicity (DLT) or a
maximum tolerated dose (MTD) or RecommendedPart2Dose (RP2D) is defined. Dose escalation
decisions will be made by the Data Review Committee and will be primarily guided by
safety data observed through the end of Cycle 1, as well as on-going assessment of safety
beyond Cycle 1 in later cohorts.
Part 2 will begin once the MTD or RP2D is determined in Part 1. Part 2 will further
characterize the safety, tolerability, Pharmacokinetic (PK), Pharmacodynamic (PD),
immunogenicity and to assess preliminary efficacy of QLF32101.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Gender unlimited, age ≥ 18 years old;
2. Volunteer to participate in clinical trials and sign informed consent;
3. AML and medium-high risk MDS patients confirmed by histology and cytology;
4. Estimated survival time is at least 12 weeks;
5. Eastern Cooperative Oncology Group (ECOG) performance status of 0~2;
6. Any adverse event related to previous anti-tumor treatment must have returned to ≤
grade 1(NCI-CTCAE v5.0);
7. Main organ function is basically normal;
8. All female and male patients with reproductive ability must agree to take effective
contraceptive methods during the study and within 6 months after the last use of the
trial drug,the blood pregnancy test of female patients of childbearing age must be
negative within 7 days before the first use of the study drug.
Exclusion Criteria:
1. Previously received hematopoietic stem cell transplantation;
2. Previous exposure to any anti-CLL-1 monoclonal antibody or CAR-T cell therapy;
3. Use other intervention study drugs within 4 weeks before the first use of the drug;
4. Any anti-tumor treatment received within 4 weeks before the first use of the drug;
5. Plan to vaccinate live attenuated vaccine within 4 weeks before the first use of the
drug or during the study period;
6. Have received systemic glucocorticoid or other immunosuppressive therapy within 14
days before the first use of the drug;
7. With known central nervous system (CNS) leukemia infiltration;
8. ECG examination during screening period showed that QTcF>450 ms for males and 470 ms
for females;
9. Major organ surgery within 4 weeks before the first use of the drug;
10. Received radiotherapy within 4 weeks before the first use of the drug;
11. There is an active infectious disease with clinical significance, which needs
intravenous antibiotic treatment, and the investigator and sponsor judge that the
patient is not suitable to participate in the clinical trial;
12. Chronic or acute active hepatitis B virus or hepatitis C virus infection;
13. Known active tuberculosis or active syphilis;
14. Known history of human immunodeficiency virus (HIV) infection；
15. Have received immunotherapy and have ≥ grade 3 immune related adverse events (irAE);
16. History of serious cardiovascular and cerebrovascular diseases;
17. History of other malignant tumors within 5 years before enrollment;
18. Breastfeeding patients；
19. Patients with known prior hypersensitivity to human or humanized monoclonal
antibodies, or hypersensitivity to any of the components of QLF32101；
20. Have uncontrollable concomitant diseases or other diseases judged by the
investigator to be unsuitable for participation in this study.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Institute of Hematology&Blood Diseases Hospital,Chinese Academy of Medical Sciences
Address:
City:
Tianjin
Country:
China
Investigator:
Last name:
Jianxiang Wang
Email:
Principal Investigator
Start date:
February 1, 2023
Completion date:
December 21, 2024
Lead sponsor:
Agency:
Qilu Pharmaceutical Co., Ltd.
Agency class:
Industry
Source:
Qilu Pharmaceutical Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05703204
