UnknownPhase 1

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

China122 participantsStarted 2023-02-01

Plain-language summary

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

Who can participate

Age range

18 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

. 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.

Exclusion criteria

. Previously received hematopoietic stem cell transplantation;
. Previous exposure to any anti-CLL-1 monoclonal antibody or CAR-T cell therapy;

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

Dose-limiting toxicity(DLT)

Timeframe: 28 Days

Maximum tolerated dose(MTD)

Timeframe: 28 Days

Recommended Phase II Dose (RP2D)

Timeframe: 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]).

Timeframe: through study completion, an average of 1 year

Trial details

NCT IDNCT05703204

SponsorQilu Pharmaceutical Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-08-21

Contact for this trial

Jianxiang Wang

022 23909120 wangjx@hotmail.com

View on ClinicalTrials.gov More Acute Myeloid Leukemia and Myelodysplastic Syndrome trials

Who can participate

Age range

18 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

. 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.

Exclusion criteria

. Previously received hematopoietic stem cell transplantation;
. Previous exposure to any anti-CLL-1 monoclonal antibody or CAR-T cell therapy;

What they're measuring

Dose-limiting toxicity(DLT)

Timeframe: 28 Days

Maximum tolerated dose(MTD)

Timeframe: 28 Days

Recommended Phase II Dose (RP2D)

Timeframe: 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]).

Timeframe: through study completion, an average of 1 year