Is NCT06552416 recruiting in Duarte, CA?

Yes, NCT06552416 is currently recruiting participants at its Duarte, CA location. This acute myeloid leukemia, in relapse clinical trial is actively enrolling qualified participants.

How do I join the acute myeloid leukemia, in relapse clinical trial in Duarte?

To join this clinical trial in Duarte, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Duarte clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Acute Myeloid Leukemia, in Relapse Clinical Trial in Duarte, CA

About This Acute Myeloid Leukemia, in Relapse Study in Duarte

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.

Sponsor: Marker Therapeutics, Inc.

Who Can Participate

Inclusion Criteria

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). If targeted therapy was not administered as part of first-line of therapy, a second regimen is allowed.

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 local laboratory

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

Exclusion Criteria

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 anti-HBs) must be screened using RT-PCR measurement of HBV DNA levels. Those who are RT PCR-positive will be excluded. Participants with serologic findings suggestive of HBV vaccination (anti HBs positivity as the only serologic marker) AND a known history of prior HBV vaccination, do not need to be tested for HBV DNA by RT PCR.

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 asymptomatic laboratory values, will be allowed on study. Prior/Concomitant Therapies

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

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Duarte?

Yes, this clinical trial (NCT06552416) has an active research site in Duarte, CA that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Acute Myeloid Leukemia, in Relapse Treatment Options in Duarte, CA

If you're searching for acute myeloid leukemia, in relapse treatment options in Duarte, CA, this clinical trial (NCT06552416) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Duarte research site is actively enrolling participants for this clinical trial. You'll receive care from experienced acute myeloid leukemia, in relapse specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all acute myeloid leukemia, in relapse clinical trials near you to find additional studies recruiting in your area.

Acute Myeloid Leukemia, in Relapse Clinical Trial in Duarte, CA

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