New treatment for relapsed or refractory precursor B-cell Acute Lymphoblastic Leukemia

An Open-label, Multi-center Phase Ib/II Study of MK-1045 (CN201) in Subjects With Precursor B-cell Acute Lymphoblastic Leukemia

This study is testing a new treatment called MK-1045 for children and adults with relapsed or hard-to-treat precursor B-cell Acute Lymphoblastic Leukemia to see how safe and effective it is.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 203 (estimated)
• Ages: 2 Years and up
• Sex: All
• Sponsor: MSD R&D (China) Co., Ltd. (Industry-sponsored)
• Drugs / interventions: CAR-T, chimeric antigen receptor
• Locations: 11 sites (Chongqing, Chongqing Municipality and 10 other locations)
• Trial ID: NCT05579132 on ClinicalTrials.gov

What this trial studies

This clinical study investigates the safety and efficacy of a new treatment, MK-1045, for patients with precursor B-cell Acute Lymphoblastic Leukemia (B-ALL) that has either relapsed or is refractory to previous treatments. The study is divided into two phases: the first phase focuses on determining the optimal and safe dosage of MK-1045, while the second phase evaluates how effectively MK-1045 treats B-ALL. Participants include both adults and children aged 2 years and older who meet specific criteria related to their leukemia diagnosis and treatment history.

Who should consider this trial

Good fit: Ideal candidates are individuals aged 2 years and older diagnosed with precursor B-cell Acute Lymphoblastic Leukemia who have experienced relapse or refractory disease.

Not a fit: Patients with a history of Burkitt's leukemia or those who have received anti-CD19 therapy within the last 3 months may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with difficult-to-treat B-ALL.

How similar studies have performed: While this approach is being explored in this specific context, similar studies targeting relapsed or refractory B-ALL have shown promise in the past.

Eligibility criteria

The main inclusion criteria 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 exclusion criteria 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

Where this trial is running

Chongqing, Chongqing Municipality and 10 other locations

• The Second Affiliated Hospital of Third Military Medical University ( Site 0008) — Chongqing, Chongqing Municipality, China (Recruiting)
• Southern Medical University Nanfang Hospital ( Site 0004) — Guangzhou, Guangdong, China (Recruiting)
• The Second Hospital of Hebei Medical University ( Site 0003) — Shijiazhuang, Hebei, China (Recruiting)
• The First Hospital of Harbin ( Site 0005) — Harbin, Heilongjiang, China (Recruiting)
• Henan Cancer Hospital-hematology department ( Site 0002) — Zhengzhou, Henan, China (Recruiting)
• Union Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology ( Site 0010) — Wuhan, Hubei, China (Recruiting)
• Tongji Hospital affiliated to Tongji Medical College of HUST ( Site 0006) — Wuhan, Hubei, China (Recruiting)
• The Affiliated Hospital of Xuzhou Medical University ( Site 0007) — Xuzhou, Jiangsu, China (Active_not_recruiting)
• West China Second University Hospital, Sichuan University ( Site 0011) — Chengdu, Sichuan, China (Completed)
• Hematology Hospital of Chinese Academy of Medical Sciences ( Site 0001) — Tianjin, Tianjin Municipality, China (Recruiting)
• The Children's Hospital of Zhejiang University School of Medicine ( Site 0009) — Hangzhou, Zhejiang, China (Completed)

Study contacts

• Principal investigator: Jianxiang Wang, Dr. — Institute of Hematology & Blood Diseases Hospital, China
• Study coordinator: Toll Free Number

Conditions Acute Lymphoblastic Leukemia