LeukemiaPhase 1NCT06522373
Phase I Trial of MT-0169 in CD38+ Acute Leukemia With Relapsed/Refractory or Measurable Residual Disease
A Phase 1 study testing MT-0169 in people with Leukemia, run by M.D. Anderson Cancer Center.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Leukemia
- What is being tested?
- MT-0169
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 21 Oct 2024to 21 Oct 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients need to be ≥ 12 years of age.
- ECOG performance status of o to 2.
- 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
- 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.
- 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.
- Relapsed or refractory disease defined by standard criteria as follows
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- 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.
- 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.
- Patients relapsing with persistent or new TP53 mutation will be eligible irrespective of CR1 duration.
- Older/unfit patients who relapse on venetoclax based maintenance regimen will be eligible irrespective of CR1 duration.
- Patients without overt relapse but positive measurable residual disease (MRD) with a response status of composite CR (cCR = CR/CRi/CRh, i.e., <5% blasts) will be eligible for the trial
- Patients with AML will be eligible if they have MRD ≥ 0.1% using multiparametric flow cytometry assay.
- Patients with T-ALL will be eligible if they have MRD ≥0.01% by multiparametric flow cytometry, or PCR/NGS (i.e., ≥ 100 residual clonal cells per million nucleated cells evaluated by T-cell repertoire sequencing by PCR and/or NGS [commercial Adaptive clonoSEQ assay]).7,11
- Patients in 2nd or higher cCR for AML or T-ALL will be eligible after at least one cycle of salvage therapy.
- Patients with MRD relapse after allo-SCT or during consolidation or maintenance therapy will be eligible.
- Patients with AML in first remission cCR will be eligible if they have adverse risk AML per ELN2022 and must have received at least,
- 1 cycle of intensive induction and 1 cycle of consolidation chemotherapy with intermediate or high-dose cytarabine based regimen,46 or ii. 4 cycles of venetoclax-based lower intensity regimen containing HMA or LDAC, due to know adverse prognosis of such patients,22,23,47,48 or iii. 4 cycles of frontline HMA-based regimen (i.e., CR1), or f. Patients with T-ALL in first remission (CR1) will be eligible if they have positive MRD after 2 cycles of frontline therapy per NCCN or ELN2023 guidelines for ALL.44,45
- Patients relapsing after allo-SCT may be eligible if they have recovered from all transplant-related toxicities, with no more than grade 1 chronic GVHD.
- Patients with actionable mutations with FDA-approved therapies, e.g., FLT3, IDH1/2 inhibitors may be enrolled after they have received at least one appropriate line of available FDA approved treatment option.
- Adequate hepatic function (direct bilirubin ≤ 2 x upper limit of normal (ULN) unless increase is due to Gilbert's disease or leukemic involvement, and AST and/or ALT ≤ 2.5 x ULN unless considered due to leukemic involvement, in which case direct bilirubin or AST and/or ALT ≤ 3 x ULN will be considered eligible.)
- Adequate renal function with creatinine clearance ≥ 30 mL/min calculated by the Cockcroft-Gault formula or measured by 24-hour urine collection
- Patients must meet the following cardiovascular parameters.
- Left ventricular ejection fraction (LVEF) ≥ 50 % by echocardiogram.
- QT interval with Fridericia correction method (QTcF) on screening electrocardiogram, defined as QTcF of ≤450 ms in males or ≤470 ms in females.
- The effects of this agent on the developing human fetus are unknown. For this reason, and because other therapeutic agents used in this trial may be teratogenic, women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for at least 90 days after last treatment. (Refer to Pregnancy Assessment Policy MD Anderson Institutional Policy #CLN1114; this applies to patients enrolled at MDA only. External participating sites will follow their own institutional policies/SOP.) This includes all female patients between the onset of menses (as early as 8 years of age) and 55 years unless the patient presents with an applicable exclusionary factor which may be one of the following:
- Postmenopausal (no menses in greater than or equal to 12 consecutive months).
- History of hysterectomy or bilateral salpingo-oophorectomy.
- Ovarian failure (follicle-stimulating hormone and estradiol in menopausal range, who have received whole pelvic radiation therapy).
- History of bilateral tubal ligation or another surgical sterilization procedure.
- Approved methods of birth control are as follows: Hormonal contraception (i.e., birth control pills, injection, implant, transdermal patch, vaginal ring), Intrauterine device (IUD), tubal ligation or hysterectomy, subject/partner post vasectomy, implantable or injectable contraceptives, and condoms plus spermicide. Not engaging in sexual activity for the total duration of the trial and the drug washout period is an acceptable practice; however, periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of birth control. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.
- Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of treatment.
- Ability to understand and the willingness to sign a written informed consent document.
Who cannot join
- 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.
- Patients with known symptomatic or uncontrolled CNS leukemia.
- Patient has systemic fungal, bacterial, viral or other infection that is exhibiting ongoing signs/symptoms related to the infection without improvement despite appropriate treatment.
- Patients with the following cardiovascular conditions:
- 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)
- Clinically significant uncontrolled hypertension at the time of screening,
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- 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.
- 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.
- 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
- Patients with a history of mediastinal irradiation.
- Prior use of any cytotoxic chemotherapy, targeted therapy, antibody-drug conjugates, immunotherapy, or other investigational therapies within 2 weeks or 5 half-lives, whichever is shorter, prior to starting MT-0169. All prior therapy related toxicities should have resolved to grade ≤1.
- Patients relapsing after allo-SCT may be eligible if they have recovered from all transplant-related toxicities and are off all immunosuppression, with no more than grade 1 chronic GVHD. Physiologic ("replacement") dose of steroids (≤10 mg prednisone or equivalent) may be acceptable. Patients must be off all immunosuppression, including calcineurin inhibitors, for at least 2 weeks or 5 half-lives, whichever is longer, prior to enrollment on study.
- Known active hepatitis B (HBV) or Hepatitis C (HCV) infection with detectable viral DNA or RNA, respectively, or known HIV infection.
- Any other medical, psychological, or social condition that may interfere with study participation or compliance, or compromise patient safety in the opinion of the investigator.
- Any previous or concomitant malignancy, except when the patient has completed definitive curative-intent treatment with chemotherapy and/or surgery and/or radiotherapy at least 3 months prior to enrollment. Patients having completed definitive treatment for the following conditions may be eligible immediately after completion of definitive curative-intent therapy, after healing of wounds, and no evidence of residual disease by examination, imaging, and/or cytology/pathology, e.g., non-melanoma skin cancers, or a carcinoma in-situ, e.g., ductal carcinoma in situ, urothelial cancer, cervical cancer, localized prostate cancer, pre-cancerous colon polyp, etc.
- Major surgery within 4 weeks prior to screening or a major wound that has not fully healed.
- Patients under legal protection measure (guardianship, trusteeship or safeguard of justice) and/or uncontrolled psychiatric comorbidities, ongoing illicit substance abuse, inability, any impairment or unwillingness to comply with the treatments, follow-up, requirements and procedures of this clinical trial.
- A known hypersensitivity or severe allergy to study drug components or diluents
- Nursing women, women of childbearing potential (WOCBP) with positive urine or serum pregnancy test, or WOCBP who are not willing to maintain adequate contraception
- Pregnant women are excluded from this study because study agents may have the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events (AEs) in nursing infants secondary to treatment of the mother with study agents, breastfeeding should be discontinued if the mother is treated on this study.
About this study
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.
Read the 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.
- Conditions
- Leukemia
- Being tested
- MT-0169
- Medical subject headings
- Leukemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MT-0169Drug
Given by Vein (IV)
| Study group | Role | What they receive |
|---|---|---|
| Escalation Adults: MT-0169 | Experimental | Not described Receives: Drug: MT-0169 |
| Escalation Pediatrics: MT-0169 | Experimental | Not described Receives: Drug: MT-0169 |
| Expansion Adults: MT-0169 | Experimental | Not described Receives: Drug: MT-0169 |
| Expansion Pediatrics: MT-0169 | Experimental | Not described Receives: Drug: MT-0169 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Measured: Through study completion; an average of 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2024
- Study start21 Oct 2024
- Primary completion21 Oct 2024
- Study completion21 Oct 2024
Why it stopped: PI Request
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LeukemiaStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Abhishek Maiti, MBBS, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06522373
- Sponsor's protocol ID
- 2024-0177
- Other IDs
- NCI-2024-06176
- Status last verified
- May 2026
- First submitted
- 22 Jul 2024
- Last updated
- 15 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Trial of MT-0169 in CD38+ Acute Leukemia With Relapsed/Refractory or Measurable Residual Disease
- ClinicalTrials.gov ID
- NCT06522373
- Acronym / sponsor ID
- 2024-0177
- Conditions
- Leukemia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: PI Request
- Enrolment
- 0 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 21 Oct 2024 (actual)
- Primary completion
- 21 Oct 2024 (actual)
- Study completion
- 21 Oct 2024 (actual)
- First posted
- 26 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Escalation Adults: MT-0169 | Experimental | Drug: MT-0169 |
| Escalation Pediatrics: MT-0169 | Experimental | Drug: MT-0169 |
| Expansion Adults: MT-0169 | Experimental | Drug: MT-0169 |
| Expansion Pediatrics: MT-0169 | Experimental | Drug: MT-0169 |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (32 listed)
- Patients need to be ≥ 12 years of age.
- ECOG performance status of o to 2.
- 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
- 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.
- 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.
Key exclusion criteria (20 listed)
- 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.
- Patients with known symptomatic or uncontrolled CNS leukemia.
- Patient has systemic fungal, bacterial, viral or other infection that is exhibiting ongoing signs/symptoms related to the infection without improvement despite appropriate treatment.
- Patients with the following cardiovascular conditions:
- Patients with a history of mediastinal irradiation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MT-0169Given by Vein (IV) | Drug | Escalation Adults: MT-0169, Escalation Pediatrics: MT-0169, Expansion Adults: MT-0169, Expansion Pediatrics: MT-0169 |
Primary outcome
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Time frame: Through study completion; an average of 1 year.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2026.
- MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Abhishek Maiti, MBBS principal investigator
M.D. Anderson Cancer Center
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MT-0169 in people with Leukemia, run by M.D. Anderson Cancer Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 32 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 15 May 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0 (time frame: Through study completion; an average of 1 year.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2026.