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Acute Myeloid LeukemiaPhase 1NCT07549464

Phase I Study Of PLM-102 In Patients With Relapsed And Refractory Acute Myeloid Leukemia

A Phase 1 study testing PLM-102 in people with Acute Myeloid Leukemia, run by M.D. Anderson Cancer Center at 1 site in United States.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

The goal of this clinical research study is to find the highest tolerable dose of PLM-102 that can be given to patients who have AML/MDS that is refractory and/or relapsed. The safety of PLM-102 will also be studied. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Acute Myeloid Leukemia
What is being tested?
PLM-102
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
1 siteUnited States
Study dates
1 Oct 2026to 1 Jun 2031
Phase
Phase 1
Are there results?
Not yet: the study is under way

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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients need to be adults with R/R AML or MDS/AML per the ICC 2022 or the WHO 2022.4,5
  • Relapsed or refractory disease following standard treatment:
  • Relapsed: Bone marrow blasts ≥5%, reappearance of blasts in the blood, or development of extramedullary disease following achievement of CR/CRi/MLFS
  • Refractory: Failure to achieve CR/CRi/MLFS following initial treatment, with evidence of persistent leukemia by blood and/or bone marrow evaluation with blasts ≥5%
  • ECOG PS 0 to 2
  • Patients with actionable mutations with available FDA-approved therapies, e.g., FLT3, IDH1/2, menin inhibitors may be enrolled after they have exhausted or are ineligible for appropriate lines of FDA approved treatment options.
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  • Patients with antecedent hematological disorder (AHD), e.g., aplastic anemia, myelodysplastic syndrome (MDS), chronic myelomonocytic leukemia (CMML) or myeloproliferative disorder or neoplasm (MPD or MPN) who have previously received a regimen appropriate for AML for the antecedent hematological disorder, and have progressed to AML, will be eligible due to recognized poor outcomes in such patients with "treated secondary AML".6,7
  • Patients relapsing after allo-SCT may be eligible if they have recovered from all transplantrelated 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.
  • Adequate hepatic function (total bilirubin ≤ 1.5 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 total bilirubin or AST and/or ALT ≤ 3 x ULN will be considered eligible).
  • Adequate renal function with creatinine clearance ≥ 45 mL/min calculated by the CockcroftGault formula or MDRD equation.
  • The effects of these agents 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.
  • 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: i. Postmenopausal (no menses in greater than or equal to 12 consecutive months). ii. History of hysterectomy or bilateral salpingo-oophorectomy. iii. Ovarian failure (follicle-stimulating hormone and estradiol in menopausal range, who have received whole pelvic radiation therapy). iv. 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. c. 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 > 15 x 10⁹/L. Hydroxyurea, and/or cytarabine (up to 2 g/m2 total) used as supportive care is permitted to meet this criterion.
  • Prior use of any cytotoxic chemotherapy, targeted therapy, radiation therapy, immunotherapy, or other clinical trial therapies within 2 weeks, prior to first dose of study treatment. Patients should have recovered from all prior therapy related toxicities. Patients may receive hydroxyurea or cytarabine for control of WBC count during this washout period.
  • Patient has uncontrolled systemic fungal, bacterial, viral or other infection with ongoing signs/symptoms despite appropriate treatment.
  • Patients with any severe gastrointestinal or metabolic condition or gastric bypass, which could interfere with absorption of oral drug.
  • Active uncontrolled comorbidities including decompensated congestive heart failure NYHA class III/IV, clinically significant, uncontrolled arrhythmia, acute respiratory failure, unstable or decompensated pulmonary disease, as judged by the treating physician.
  • Decompensated congestive heart failure, hypokalemia, prolonged QT interval corrected for heart rate (QTc) (as calculated using Fridericia's formula) to greater than 450 msec for males, or to greater than 470 msec for females or long QT syndrome, or history of Torsades de pointes. Patients with bundle branch block or pacemaker and prolonged QTc interval are permitted after appropriate correction, (e.g., Bogossian formula, or others) or after discussion with the PI and/or cardiologist.
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  • Active hepatitis B (HBV) or Hepatitis C (HCV) infection with detectable viral DNA or RNA, respectively, or known HIV infection. Patients with history of hepatitis with undetectable viral load will be eligible.
  • 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 malignancy, except when the patient has completed definitive curative-intent treatment with chemotherapy and/or surgery and/or radiotherapy at least 1 month 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 or imaging or cytology/pathology, e.g., non-melanoma skin cancers, or any 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Abhishek Maiti, MBBS contact

(713) 745-3228

amaiti@mdanderson.org

United States1 site

  • UT MD Anderson

    Houston, Texas, 77030

    Abhishek Maiti, MBBS, 713-745-3228, amaiti@mdanderson.org

    Abhishek Maiti, MBBS

Other trials in United States

About this study

The goal of this clinical research study is to find the highest tolerable dose of PLM-102 that can be given to patients who have AML/MDS that is refractory and/or relapsed. The safety of PLM-102 will also be studied.

Read the detailed description

Primary Objective:

To study the safety and tolerability of PLM-102 in terms of treatment emergent adverse events (TEAE) and dose limiting toxicities (DLT). To establish the RP2D of PLM-102 based on the totality of the data.

Secondary Objectives:

To estimate rate of CR/CRh by 4 cycles of treatment To estimate overall response rate (ORR=CR/CRh/CRi/MLFS/PR) by 4 cycles of treatment To determine duration of response (DOR) of CR/CRh To determine overall survival (OS)

Exploratory Objectives:

To characterize the pharmacokinetics (PK) of PLM-102 and its metabolite(s) To characterize pharmacodynamic (PD) biomarkers with PLM-102 treatment

Being tested
PLM-102
Medical subject headings
Leukemia, Myeloid, Acute

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PLM-102Drug

    Given by mouth

Study groups in NCT07549464
Study groupRoleWhat they receive
Dose Escalation of PLM-102ExperimentalTreatment will be adminstered on an outpatient basis
Receives: Drug: PLM-102

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety and Adverse Events (AEs)

    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.

  1. First posted24 Apr 2026
  2. Study start1 Oct 2026 (estimated)
  3. Primary completion1 Jun 2029 (estimated)
  4. Study completion1 Jun 2031 (estimated)

Resources

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
12 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07549464
Sponsor's protocol ID
2026-0006
Other IDs
NCI-2026-03138
Status last verified
Oct 2026
First submitted
20 Apr 2026
Last updated
2 Nov 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing PLM-102 in people with Acute Myeloid Leukemia, run by M.D. Anderson Cancer Center at 1 site in United States.

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 14 inclusion and 14 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: opening soon, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Abhishek Maiti, MBBS ((713) 745-3228, amaiti@mdanderson.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety and Adverse Events (AEs) (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?

On the ClinicalTrials.gov record for NCT07549464.

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 2 Nov 2026.

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