Promising leukemia combo trial pulled before it even started
NCT ID NCT07585734
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This trial aimed to test a new drug called CM313, a CD38-targeting antibody, combined with a chemotherapy regimen inspired by pediatric treatments for adults newly diagnosed with T-cell acute lymphoblastic leukemia (T-ALL). The goal was to see if the combination could improve remission rates and reduce the chance of relapse. However, the study was withdrawn before enrolling any participants, so no results are available.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- CM313 (a CD38 monoclonal antibody) combined with a pediatric-inspired chemotherapy regimen (vincristine, daunorubicin, cyclophosphamide, L-asparaginase, prednisone)
- What this could lead to
- If successful, this approach could improve remission rates and reduce relapse in adults with T-ALL, a hard-to-treat leukemia.
- What could go wrong
- The trial was withdrawn before enrolling any participants, so no data exist. It is very early-stage (phase I/II) and the combination may cause significant side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Expected to start
-
Apr 2025
An estimate. Start dates often move.
- Expected to finish
-
Apr 2027
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
14 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Diagnosis of T-cell acute lymphoblastic leukemia (T-ALL) according to the World Health Organization (WHO) 2022 classification or International Consensus Classification (ICC) criteria. * Age ≥14 years, regardless of gender. * CD38-positive expression on leukemic cells, confirmed by multicolor flow cytometry. * Eastern Cooperative Oncology Group Performance Status (ECOG-PS) score of 0-2. * Laboratory parameters (assessed within 7 days prior to treatment): Total bilirubin ≤1.5 × upper limit of normal (ULN) for the corresponding age group. AST and ALT ≤2.5 × ULN for the corresponding age group. Serum creatinine \<2 × ULN for the corresponding age group. Cardiac enzymes \<2 × ULN for the corresponding age group. Left ventricular ejection fraction (LVEF) \>50%, measured by echocardiography (ECHO). Informed Consent Requirements: A written informed consent form must be signed prior to any study-specific procedures. The consent may be provided by the patient themselves, their legal guardian, or immediate family member. If obtaining consent directly from the patient is deemed clinically inappropriate or detrimental to the patient's treatment, consent must be obtained from the legal guardian or immediate family member. Exclusion Criteria: * Active central nervous system (CNS) leukemia or clinical manifestations of isolated extramedullary involvement of ALL. * Relapsed/refractory patients (however, prior cytoreductive therapies such as hydroxyurea, corticosteroids, cyclophosphamide, or cytarabine are permitted). * Chronic obstructive pulmonary disease (COPD) with forced expiratory volume in 1 second (FEV1) \<60% of predicted value, confirmed by pulmonary function testing. * Moderate to severe persistent asthma within the past 2 years, or uncontrolled asthma of any type at screening. * Positive serology for human immunodeficiency virus (HIV). * Positive syphilis serology. * Suspected or confirmed active tuberculosis (TB) infection. * Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection, defined as: 1. Hepatitis B surface antigen (HBsAg)-positive; 2. Hepatitis B core antibody (HBcAb)-positive with detectable HBV DNA; 3. Anti-HCV antibody-positive with detectable HCV RNA. * Concurrent malignancies of other organ systems requiring active therapy. * Active cardiac disease, defined as any of the following: 1. History of uncontrolled or symptomatic angina; 2. Myocardial infarction within 6 months prior to study enrollment. 3. History of arrhythmias requiring pharmacologic treatment or clinically significant arrhythmia; 4. Uncontrolled or symptomatic congestive heart failure (CHF) \> New York Heart Association (NYHA) Class II; * Severe uncontrolled active infection. * Psychiatric disorders that may compromise the patient's ability to complete treatment or provide informed consent. * Any other condition deemed by the investigator to render the patient unsuitable for study participation.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
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