Acute Myeloid Leukemia and Myelodysplastic SyndromePhase 1NCT05703204
A Study of QLF32101 in Patients With Acute Myeloid Leukemia and Myelodysplastic Syndrome
A Phase 1 study testing QLF32101 in people with Acute Myeloid Leukemia and Myelodysplastic Syndrome, run by Qilu Pharmaceutical Co., Ltd. at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myeloid Leukemia and Myelodysplastic Syndrome
- What is being tested?
- QLF32101
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 122 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2023to 21 Dec 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Gender unlimited, age ≥ 18 years old;
- Volunteer to participate in clinical trials and sign informed consent;
- AML and medium-high risk MDS patients confirmed by histology and cytology;
- Estimated survival time is at least 12 weeks;
- Eastern Cooperative Oncology Group (ECOG) performance status of 0~2;
- Any adverse event related to previous anti-tumor treatment must have returned to ≤ grade 1(NCI-CTCAE v5.0);
- Main organ function is basically normal;
- 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.
Who cannot join
- Previously received hematopoietic stem cell transplantation;
- Previous exposure to any anti-CLL-1 monoclonal antibody or CAR-T cell therapy;
- Use other intervention study drugs within 4 weeks before the first use of the drug;
- Any anti-tumor treatment received within 4 weeks before the first use of the drug;
- Plan to vaccinate live attenuated vaccine within 4 weeks before the first use of the drug or during the study period;
- Have received systemic glucocorticoid or other immunosuppressive therapy within 14 days before the first use of the drug;
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- With known central nervous system (CNS) leukemia infiltration;
- ECG examination during screening period showed that QTcF>450 ms for males and 470 ms for females;
- Major organ surgery within 4 weeks before the first use of the drug;
- Received radiotherapy within 4 weeks before the first use of the drug;
- 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;
- Chronic or acute active hepatitis B virus or hepatitis C virus infection;
- Known active tuberculosis or active syphilis;
- Known history of human immunodeficiency virus (HIV) infection；
- Have received immunotherapy and have ≥ grade 3 immune related adverse events (irAE);
- History of serious cardiovascular and cerebrovascular diseases;
- History of other malignant tumors within 5 years before enrollment;
- Breastfeeding patients；
- Patients with known prior hypersensitivity to human or humanized monoclonal antibodies, or hypersensitivity to any of the components of QLF32101；
- Have uncontrollable concomitant diseases or other diseases judged by the investigator to be unsuitable for participation in this study.
Trial locations and contacts
1 site in 1 country.
China1 site
Institute of Hematology&Blood Diseases Hospital,Chinese Academy of Medical Sciences
Tianjin, Tianjin Municipality
Jianxiang Wang
About this study
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
This study aimed to evaluate the safety,tolerability and preliminary efficacy of QLF32101 administered intravenously and subcutaneously in patients with R/R, AML.
Read the 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.
- Being tested
- QLF32101
- Medical subject headings
- GATA2 Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QLF32101Drug
The dose is given weekly and observed for 28 days(DLT observation period).Single agent treatment.
| Study group | Role | What they receive |
|---|---|---|
| QLF32101 | Experimental | single arm with QLF32101 treatment Receives: Drug: QLF32101 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-limiting toxicity(DLT)
Measured: 28 Days
Maximum tolerated dose(MTD)
Measured: 28 Days
Recommended Phase II Dose (RP2D)
Measured: through study completion, an average of 1 year
R/R AML: cCR rate; Medium and high risk MDS: ORR (CR+complete remission of bone marrow [mCR]+PR+hematological improvement [HI]).
Measured: through study completion, an average of 1 year
Secondary outcomes (3)
Safety index:TEAEs,TRAEs,SAERs,TRSAEs.
Measured: through study completion, an average of 1 year
PK parameter
Measured: through study completion, an average of 1 year
Serum titer of ADAs against QLF32101
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2023
- Study start1 Feb 2023 (estimated)
- Primary completion21 Aug 2024 (estimated)
- Study completion21 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myeloid Leukemia and Myelodysplastic SyndromeStudies of the same condition, open and under way.
- More trials run by Qilu Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 122 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qilu Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05703204
- Sponsor's protocol ID
- QLF32101-101
- Status last verified
- Jan 2023
- First submitted
- 11 Jan 2023
- Last updated
- 31 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05703204
- Acronym / sponsor ID
- QLF32101-101
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 122 participants (estimated)
- Lead sponsor
- Qilu Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Feb 2023 (estimated)
- Primary completion
- 21 Aug 2024 (estimated)
- Study completion
- 21 Dec 2024 (estimated)
- First posted
- 27 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| QLF32101 | Experimental | Drug: QLF32101single arm with QLF32101 treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Gender unlimited, age ≥ 18 years old;
- Volunteer to participate in clinical trials and sign informed consent;
- AML and medium-high risk MDS patients confirmed by histology and cytology;
- Estimated survival time is at least 12 weeks;
- Eastern Cooperative Oncology Group (ECOG) performance status of 0~2;
Key exclusion criteria (20 listed)
- Previously received hematopoietic stem cell transplantation;
- Previous exposure to any anti-CLL-1 monoclonal antibody or CAR-T cell therapy;
- Use other intervention study drugs within 4 weeks before the first use of the drug;
- Any anti-tumor treatment received within 4 weeks before the first use of the drug;
- Plan to vaccinate live attenuated vaccine within 4 weeks before the first use of the drug or during the study period;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QLF32101The dose is given weekly and observed for 28 days(DLT observation period).Single agent treatment. | Drug | QLF32101 |
Primary outcome
Dose-limiting toxicity(DLT)
Time frame: 28 Days
Maximum tolerated dose(MTD)
Time frame: 28 Days
Recommended Phase II Dose (RP2D)
Time frame: through study completion, an average of 1 year
R/R AML: cCR rate; Medium and high risk MDS: ORR (CR+complete remission of bone marrow [mCR]+PR+hematological improvement [HI]).
Time frame: through study completion, an average of 1 year
3 secondary outcomes
Safety index:TEAEs,TRAEs,SAERs,TRSAEs.
Time frame: through study completion, an average of 1 year
PK parameter
Time frame: through study completion, an average of 1 year
Serum titer of ADAs against QLF32101
Time frame: through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing QLF32101 in people with Acute Myeloid Leukemia and Myelodysplastic Syndrome, run by Qilu Pharmaceutical Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jianxiang Wang (022 23909120, wangjx@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose-limiting toxicity(DLT) (time frame: 28 Days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2023.