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New treatment option for Acute Lymphoblastic Leukemia
Official title A Clinical Study of MK-1045 (CN201) in People With Precursor B-cell Acute Lymphoblastic Leukemia (MK-1045-002)
ClinicalTrials.gov ID: NCT05579132
What this study is testing
What is MK-1045?
MK-1045 is an investigational medicine, given as an once-weekly infusion into a vein, being studied as a potential treatment for acute lymphoblastic leukemia.
Also referred to as CN201.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Researchers are looking for new ways to treat people with a type of blood cancer called precursor B-cell Acute Lymphoblastic Leukemia (B-ALL) that is relapsed- the cancer has come back after treatment, or refractory - the current treatment has stopped working to slow or stop cancer growth. This study will have two parts.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 2 and older
You may be able to join if
- The main include but are not limited to:
- Adult participants must be age 18 or older
- Pediatric participants must be at least 2 years old and less than 18 years old.
- Diagnosis of precursor B-cell acute lymphoblastic leukemia (B-ALL) and have more than 5% blasts in the bone marrow by morphological assessment
- Participants with Ph-negative B-ALL with any of the following refractory/relapse criteria:
You likely can't join if
- include but are not limited to:
- History of Burkitt's leukemia.
- Received anti-CD19 therapy within 3 months prior to entering the study
- Received allogeneic HSCT within 12 weeks prior to entering the study
- Received prior treatment with chimeric antigen receptor T cell (CAR-T) within 3 months prior to entering the study
- History or presence of clinically relevant central nervous system (CNS) pathology
See the full eligibility criteria
- The main include but are not limited to:
- Adult participants must be age 18 or older
- Pediatric participants must be at least 2 years old and less than 18 years old.
- Diagnosis of precursor B-cell acute lymphoblastic leukemia (B-ALL) and have more than 5% blasts in the bone marrow by morphological assessment
- Participants with Ph-negative B-ALL with any of the following refractory/relapse criteria:
- Failure to achieve complete remission after initial induction therapy;
- Failure to achieve complete remission after salvage treatment;
- Relapse with first remission duration ≤12 months
- Second or later relapse
- Relapse after allogeneic HSCT
- Participants with Ph-positive B-ALL who have received 2 (or more) tyrosine kinase inhibitors (TKIs) and meet the refractory/relapse criteria above or, those with the T315I mutation The main
- include but are not limited to:
- History of Burkitt's leukemia.
- Received anti-CD19 therapy within 3 months prior to entering the study
- Received allogeneic HSCT within 12 weeks prior to entering the study
- Received prior treatment with chimeric antigen receptor T cell (CAR-T) within 3 months prior to entering the study
- History or presence of clinically relevant central nervous system (CNS) pathology
- History of clinically symptomatic metastases to the central nervous system or meninges, or other evidence of uncontrolled metastases to the CNS or meninges
- History of immunodeficiency, including history of any positive test result for human immunodeficiency virus (HIV) antibody.
- History of serious cardiovascular and cerebrovascular disease
- Has active autoimmune diseases that may relapse
The study team makes the final eligibility decision.
Where it's taking place
- Chongqing, Chongqing Municipality, China
- Guangzhou, Guangdong, China
- Shijiazhuang, Hebei, China
- Harbin, Heilongjiang, China
- Zhengzhou, Henan, China
- Wuhan, Hubei, China
- Xuzhou, Jiangsu, China
- Chengdu, Sichuan, China
- Tianjin, Tianjin Municipality, China
- Hangzhou, Zhejiang, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 2 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chongqing, Chongqing Municipality, China; Guangzhou, Guangdong, China; Shijiazhuang, Hebei, China; Harbin, Heilongjiang, China; Zhengzhou, Henan, China; Wuhan, Hubei, China and 4 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.