A Study of QLF32101 in Patients With Acute Myeloid Leukemia and Myelodysplastic Syndrome

Acute Myeloid Leukemia and Myelodysplastic Syndrome Clinical Trial

Official title:

A Phase 1 Clinical Study on the Safety, Tolerance, Pharmacokinetics and Preliminary Efficacy of QLF32101 in Patients With Acute Myeloid Leukemia and Myelodysplastic Syndrome

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05703204
• Other study ID #: QLF32101-101
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: February 1, 2023
• Est. completion date: December 21, 2024

Study information

• Verified date: January 2023
• Source: Qilu Pharmaceutical Co., Ltd.
• Contact: Jianxiang Wang
• Phone: 022 23909120
• Email: wangjx[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study aimed to evaluate the safety,tolerability and preliminary efficacy of QLF32101 administered intravenously and subcutaneously in patients with R/R, AML.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 122
• Est. completion date: December 21, 2024
• Est. primary completion date: August 21, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Myeloid Leukemia and Myelodysplastic Syndrome
• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute
• Myelodysplastic Syndromes
• Preleukemia
• Syndrome

Intervention

Drug:
• QLF32101
The dose is given weekly and observed for 28 days(DLT observation period).Single agent treatment.

Locations

Country	Name	City	State
China	Institute of Hematology&Blood Diseases Hospital,Chinese Academy of Medical Sciences	Tianjin	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
Qilu Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dose-limiting toxicity(DLT)		28 Days
Primary	Maximum tolerated dose(MTD)		28 Days
Primary	Recommended Phase II Dose (RP2D)		through study completion, an average of 1 year
Primary	R/R AML: cCR rate; Medium and high risk MDS: ORR (CR+complete remission of bone marrow [mCR]+PR+hematological improvement [HI]).		through study completion, an average of 1 year
Secondary	Safety index:TEAEs,TRAEs,SAERs,TRSAEs.		through study completion, an average of 1 year
Secondary	PK parameter		through study completion, an average of 1 year
Secondary	Serum titer of ADAs against QLF32101		through study completion, an average of 1 year