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 range18 Years

SexALL

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;
✕. 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;
✕. 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;

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 range18 Years

SexALL

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;
✕. 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;
✕. 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;

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