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Phase I Trial of MT-0169 in CD38+ Acute Leukemia With Relapsed/Refractory or Measurable Residual Disease | Clinical Trials | Clareo Health

WITHDRAWNPHASE1

Phase I Trial of MT-0169 in CD38+ Acute Leukemia With Relapsed/Refractory or Measurable Residual Disease

NCT06522373•M.D. Anderson Cancer Center

View on ClinicalTrials.gov

Summary

To learn if MT-0169 is safe to give to patients with AML or T-ALL. The effects of this drug will also be studied.

Detailed Description

Primary Objective: To study the safety and tolerability of MT-0169. Secondary Objectives: To study preliminary efficacy of MT-0169 in terms of morphologic and MRD response rates and survival outcomes. Exploratory Objectives: To determine the plasma concentration and pharmacokinetic (PK) parameters of MT-0169. To estimate proportion of MRD+ patients who achieved 1 log fold reduction in MRD burden. To explore, additional response and survival outcomes, potential biomarkers of response, resistance and impact on immune microenvironment.

Eligibility

Age

12 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Patients need to be ≥ 12 years of age.
•2. ECOG performance status of o to 2.
•3. Patients need to have a confirmed diagnosis of T-ALL, or AML, MDS/AML, (10% to 19% blasts), or mixed or biphenotypic leukemia, per the International Consensus Classification or the WHO classification.40,41
•4. Patients need to have either relapsed or refractory disease: T-ALL, AML, MDS/AML, MPAL, biphenotypic leukemia; or patients with AML or T-ALL in CR/CRi/CRh with measurable residual disease (MRD), and no available standard or approved treatment options. Patients with MPAL or biphenotypic leukemia will only be eligible during the dose escalation phase.
•5. Patients will need to have positive CD38 expression on leukemia cell population for dose escalation cohort and CD38 expression ≥20% on leukemia cell population by flow cytometry or IHC for dose expansion cohorts as assessed by standard of care flow cytometry.
•6. Relapsed or refractory disease defined by standard criteria as follows
•a. Relapsed: Bone marrow blasts ≥5%, reappearance of blasts in the blood, or development of extramedullary disease following achievement of CR/CRi/MLFS b. Refractory: Failure to achieve CR/CRi/MLFS following initial treatment, with evidence of persistent leukemia by blood and/or bone marrow evaluation c. Patients with AML must have received appropriate prior therapy in order for patient to be deemed relapsed or refractory, including any of the following i. At least 1 cycle of purine analogue containing intensive induction chemotherapy regimen, e.g., FLAG-Ida, CLIA or CLAG-M or similar regimens with or without venetoclax.42,43 ii. At least 1 cycle of intensive induction chemotherapy with venetoclax, e.g., 7 + 3 or CPX-351 with venetoclax iii. At least 2 cycles of intensive induction chemotherapy such as 7 + 3 or 5 + 2 or similar regimens without venetoclax iv. 2 cycles of venetoclax with HMA/LDAC +/- other agents v. 4 cycles of HMA-based regimen d. Patients with T-ALL should have received at least 1 cycle of a standard or appropriate frontline regimen per NCCN or ELN2023 guidelines for ALL.44,45 e. Patients with mixed or biphenotypic leukemia should have received one AML or ALL type regimen as mentioned above f. Pediatric patients need to have R/R disease after at least one line of standard pediatric frontline regimen.
•7. For patients in first relapse, the dose escalation cohort will only enroll patients in early first relapse, i.e., first remission duration of ≤12 months.
•1. Patients relapsing with persistent or new TP53 mutation will be eligible irrespective of CR1 duration.
•2. Older/unfit patients who relapse on venetoclax based maintenance regimen will be eligible irrespective of CR1 duration.
+25 more criteria

Exclusion Criteria

•1. Patient has a white blood cell count \> 10 x 10⁹/L. Hydroxyurea, and/or cytarabine (up to 2 g/m2 total) used as supportive care is permitted to meet this criterion.
•2. Patients with known symptomatic or uncontrolled CNS leukemia.
•3. Patient has systemic fungal, bacterial, viral or other infection that is exhibiting ongoing signs/symptoms related to the infection without improvement despite appropriate treatment.
•4. Patients with the following cardiovascular conditions:
•1. Congestive heart failure, NYHA class ≥II, cardiomyopathy, active ischemia, or any other uncontrolled cardiac condition such as angina pectoris or myocardial infarction, clinically significant arrhythmia requiring therapy including anticoagulants within the past 6 months or at screening, (stable medical therapy for \> 6 months is acceptable)
•2. Clinically significant uncontrolled hypertension at the time of screening,
•3. Patients with a history of documented pericarditis (any CTCAE grade) or pericardial effusions of at least CTCAE Grade 3 within 3 months before the start of treatment with MT-0169.
•4. Received chemotherapy with anthracycline agents at the doxorubicin equivalent cumulative dose (sum for all agents combined) of 450 mg/m2 body surface area, or a lower total doxorubicin equivalent cumulative dose that, in the opinion of the Investigator, would increase the risk of cardiomyopathy in this study.
•i. For patients who have received a cumulative dose of an anthracycline of more than 300 mg/m2 , approval must first be obtained from the Medical Monitor
•5. Patients with a history of mediastinal irradiation.
+1 more criteria

Key Dates

Start Date

October 21, 2024

Primary Completion Date

October 21, 2024

Completion Date

October 21, 2024

Last Updated

February 24, 2026

Conditions

Leukemia

Interventions

MT-0169

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 24, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Phase I Trial of MT-0169 in CD38+ Acute Leukemia With Relapsed/Refractory or Measurable Residual Disease

Inclusion Criteria

Exclusion Criteria

Azacitidine and Abatacept in Relapsed or Refractory T-Cell Lymphoma

Long-term Evaluation and Follow-up Care of Patients Treated With Stem Cell Transplants

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