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Monoclonal Antibodies

MT-0169 for Leukemia

Phase 1
Waitlist Available
Led By Abhishek Maiti, MBBS
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients need to be ≥ 12 years of age
ECOG performance status of 0 to 2
Must not have
Patients with known symptomatic or uncontrolled CNS leukemia
Major surgery within 4 weeks prior to screening or a major wound that has not fully healed
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

Summary

This trial will test if MT-0169 is safe for patients with AML or T-ALL, as well as study its effects. "This trial aims to determine if MT-0169 is

Who is the study for?
This trial is for patients with acute leukemia (AML or T-ALL) who have either not responded to previous treatments (relapsed/refractory) or still show signs of disease. Specific details on eligibility criteria are not provided.
What is being tested?
The safety and effects of a new drug called MT-0169 are being tested in this Phase I trial for individuals with CD38+ acute leukemia, specifically AML or T-ALL.
What are the potential side effects?
Potential side effects of MT-0169 are not listed, but common ones may include reactions at the injection site, fatigue, fever, nausea, and blood count changes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 12 years old or older.
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I can care for myself and am up and about more than 50% of my waking hours.
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I have been diagnosed with a specific type of leukemia.
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My condition has not improved or has worsened despite treatment.
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My first cancer remission lasted 12 months or less.
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My heart health meets the required standards.
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My leukemia cells show a high level of CD38.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have leukemia that is affecting my brain and is not under control.
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I have not had major surgery or unhealed major wounds in the last 4 weeks.
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I am not pregnant, nursing, or if capable of becoming pregnant, I am using effective birth control.
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I have an ongoing infection that hasn't improved with treatment.
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I have a heart condition.
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I have an active hepatitis B or C infection, or I am HIV positive.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Trial Design

4Treatment groups
Experimental Treatment
Group I: Expansion Pediatrics: MT-0169Experimental Treatment1 Intervention
Group II: Expansion Adults: MT-0169Experimental Treatment1 Intervention
Group III: Escalation Pediatrics: MT-0169Experimental Treatment1 Intervention
Group IV: Escalation Adults: MT-0169Experimental Treatment1 Intervention

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
3,039 Previous Clinical Trials
1,799,649 Total Patients Enrolled
461 Trials studying Leukemia
31,749 Patients Enrolled for Leukemia
Abhishek Maiti, MBBSPrincipal InvestigatorM.D. Anderson Cancer Center
3 Previous Clinical Trials
267 Total Patients Enrolled
3 Trials studying Leukemia
267 Patients Enrolled for Leukemia
~35 spots leftby Jul 2028
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