A Clinical Study of MK-1045 (CN201) in People With Precursor B-cell Acute Lymphoblastic Leukemia (MK-1045-002)

Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age2+
SponsorMSD R&D (China) Co., Ltd.

About this trial

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. In the first part (dose escalation phase) the goal is to learn about the safety of a study treatment, MK-1045, and to find the best dose level of MK-1045 that is tolerated and may work to treat B-ALL. In the second part (Phase II) researchers want to learn how well MK-1045 works to treat B-ALL.

Eligibility criteria

Qualifiers

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

Failure to achieve complete remission after initial induction therapy;

Disqualifiers

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

Trial design

Treatments tested in this trial

  • MK-1045

Treatment groups

203 Participants
are divided into 2 treatment groups

Sponsors and collaborators