Promising leukemia combo trial pulled before it even started

NCT ID NCT07585734

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled This study
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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 However, the study was withdrawn before enrolling any participants, so no results are available.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The trial was withdrawn before enrolling any participants, so no data exist.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

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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