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Tests treatment safety and results for Acute Myeloid Leukemia, in Relapse
Official title Safety of MT-401-OTS in Patients With Relapsed AML or MDS
ClinicalTrials.gov ID: NCT06552416
What this study is testing
What is MT-401-OTS?
MT-401-OTS is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for acute myeloid leukemia, in relapse.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is a Phase 1 multicenter, open-label study evaluating the safety and efficacy of escalating doses of MT-401-OTS in 2 participant populations: 1) Those with intermediate or high-risk AML per 2022 ELN criteria who have evidence of MRD and/or \</= 10% blast following prior induction therapy or at least 4 cycles of nonintensive therapy and 2) those with high- or very-high-risk MDS per 2023 IWG criteria and who have residual disease with \</= 10% blasts following treatment with an HMA-based therapy.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 65 and older
You may be able to join if
- General
- Must be ≥ 65 years of age and capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in...
- Must have a life expectancy ≥ 12 weeks
- Must have an ECOG performance status of 0-2
- Must have available MT-401-OTS product with a ≥ 2/8 HLA match Disease Characteristics
You likely can't join if
- Disease-Related
- Have leukemic involvement in the CNS
- Have other extramedullary disease involvement (except hepatosplenic involvement)
- Have APL Medical Conditions
- Have primary immunodeficiency
- Have severe or uncontrolled autoimmune disorder
See the full eligibility criteria
Who can join
- General
- Must be ≥ 65 years of age and capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICF and in the protocol, at the time of signing the ICF
- Must have a life expectancy ≥ 12 weeks
- Must have an ECOG performance status of 0-2
- Must have available MT-401-OTS product with a ≥ 2/8 HLA match Disease Characteristics
- For participants with AML:
- Must have a confirmed diagnosis of AML or MDS/AML per 2022 WHO Classification of Haematolymphoid Tumours: Myeloid and Histiocytic/Dendritic Neoplasms or 2022 International Consensus Criteria
- Must have intermediate or high-risk disease based on ELN 2022 criteria.
- If no targetable mutation is present, must have received 1 prior standard regimen with at least 4 cycles of standard therapy containing an HMA or a standard cytarabine-containing induction therapy
- If targetable mutation is present, must have received a regimen that includes commercially available targeted therapy unless unable to tolerate or the participant declines (must be documented in the informed consent)...
- Must have either: ≤ 10% bone marrow blasts and ≤ 5% peripheral blasts during screening and not be considered to have hyperproliferating disease at diagnosis or after treatment OR Evidence of MRD based on evaluation at a...
- For participants with MDS:
- Must have confirmed diagnosis of MDS based on 2022 WHO Classification of Haematolymphoid Tumours: Myeloid and Histiocytic/Dendritic Neoplasms or 2022 ICC criteria
- Must have high-risk or very-high-risk disease based on IPSS-M (ie, not evolved to AML)
- Must have received standard treatment with at least 4 cycles of an HMA and have evidence of continued disease, including morphologic disease or MRD-positive
- Must have bone marrow blasts ≤ 10% at screening Health Status
- Must have adequate coagulation, hepatic, renal, and cardiac function:
- PT/INR and PTT/aPTT \< 1.3 × ULN
- AST and ALT \< 3 × ULN; for participants with leukemic infiltration of the liver (documented by biopsy or imaging), AST and ALT \< 5 × ULN is permitted.
- Total bilirubin ≤ 1.5 × ULN unless bilirubin rise is due to Gilbert's syndrome or of nonhepatic origin (2 × ULN is permitted)
- eGFR ≥ 40 mL/min by the MDRD formula
- LVEF ≥ 45% (prior to apheresis and lymphodepletion) Sex
- Women of childbearing potential are eligible to participate if they agree to the following during the intervention period and for at least 1 year after the last infusion of MT-401-OTS:
- Must use a contraceptive method that is highly effective (ie, with a failure rate of \< 1% per year; see Section 10.3), preferably with low user dependency PLUS
- Must agree not to donate eggs (ie, ova and oocytes) for the purpose of reproduction
- Male participants are eligible to participate if they agree to the following during the intervention period and for at least 6 months after the last infusion of MT-401-OTS:
- Must refrain from donating sperm PLUS either:
- Must be abstinent from intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis) and agree to remain abstinent OR
- Must agree to use a male condom AND should also be advised of the benefit for a nonpregnant female partner to use a highly effective method of contraception (see Section 10.3) as a condom may break or leak
What rules you out
- Disease-Related
- Have leukemic involvement in the CNS
- Have other extramedullary disease involvement (except hepatosplenic involvement)
- Have APL Medical Conditions
- Have primary immunodeficiency
- Have severe or uncontrolled autoimmune disorder
- Have a history or presence of clinically relevant CNS pathology, such as epilepsy, seizure, aphasia, stroke, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome or psychosis
- Have active malignancies (ie, those that are progressing or have required treatment change in the last 24 months) other than the disease being treated under study. Exceptions to this inclusion include the following:
- Nonmelanoma skin cancer treated within the last 24 months that is considered completely cured
- Adequately treated breast lobular carcinoma in situ and breast ductal carcinoma in situ
- Adequately treated cervical carcinoma in situ without evidence of disease
- History of localized breast cancer and receiving antihormonal agents, or history of localized prostate cancer (N0M0) and receiving androgen-deprivation therapy
- A malignancy that is considered cured with minimal risk of recurrence
- Have any active systemic infection requiring therapy (viral, bacterial, or fungal), including HIV
- Have active hepatitis B or C infection or other clinically active liver diseases, as defined below:
- Seropositivity for hepatitis B as defined by a positive test for HbsAg Participants with resolved infection (ie, participants who are HbsAg-negative with antibodies to total anti-HBc with or without the presence of...
- Active hepatitis C infection as defined by being positive for a nucleic acid test for HCV RNA
- Have Class III or IV congestive heart failure per New York Association
- Have unstable angina
- Have a history or evidence of current, uncontrolled, clinically significant, unstable arrhythmias
- Have an oxygen saturation on room air of ≤ 92%
- Have clinically significant reversible nonhematologic toxicities from prior cancer therapy that have not recovered to Grade 1 or baseline Note: Participants with clinically nonsignificant toxicities, such as...
- Received prior treatments for underlying malignancy, except as specified in the Inclusion Criteria. Participants with AML secondary to MDS may have received prior treatment for MDS.
- Have had prior HSCT
- Are receiving concurrent therapies other than HMA, as delineated in the study design
- Have received hematopoietic growth factors within 2 days of lymphodepleting conditioning regimen
- Have a history of severe allergic reactions/intolerance to any of the study intervention components, including the conditioning regimen, HMA, or DSMO, or to tocilizumab
- Have had major surgery within 14 days (central line placement allowed)
- Have received systemic steroids (exception: physiological doses of steroids allowed) or other immunosuppressive therapies within 14 days prior to lymphodepleting conditioning regimen Other
- Are unable to be matched with MT-401-OTS product inventory
- Are pregnant or breastfeeding
- Have any other issue that, in the opinion of the treating physician, would make the participant ineligible for the study or unable to comply with its requirements
The study team makes the final eligibility decision.
Where it's taking place
- Duarte, California, United States
- Tampa, Florida, United States
- Kansas City, Kansas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Duarte, California, United States; Tampa, Florida, United States; Kansas City, Kansas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.