Acute LeukemiaPhase 2/3NCT07157514
Radioimmunotherapy Conditioning With 131I- Apamistamab for Allogeneic Transplant in Relapse/Refractory AML
A Phase 2/3 study testing 131I-apamistamab, Fludarabine and Cyclophosphamide in people with Acute Leukemia and Myeloid Leukemia, run by Actinium Pharmaceuticals.
Trial summary
This is a multicenter, open-label study in people aged 18 and older with relapsed or refractory acute myeloid leukemia. It has two parts. In Phase 2, we are testing three radiation dose levels of 131I-apamistamab combined with fludarabine and low-dose whole-body radiation before stem cell transplant to find the safest… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Leukemia, Myeloid Leukemia, Acute Myelogenous Leukemia
- What is being tested?
- 131I-apamistamab, Fludarabine and Cyclophosphamide
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 306 participants
- Where
- No sites listed yet
- Study dates
- Jan 2026to Feb 2034
- Phase
- Phase 2/3
- 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
- Have active, relapsed, or refractory AML with ≥5% and ≤20% blasts in the marrow.
- 2R/R AML is defined as one of the following: Primary induction failure after ≥2 cycles of therapy, first early relapse after remission <6 months, relapse refractory to salvage combination therapy or second or subsequent relapse
- Documented CD45 expression by leukemic cells via flow cytometry.
- ≥18 years of age and not suitable for myeloablative conditioning regimen.
- Circulating blast count <10,000/mm³ (hydroxyurea allowed).
- Calculated creatinine clearance (Cockcroft-Gault) >50 mL/min.
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- Adequate hepatic function: AST/ALT ≤2 × ULN; total bilirubin ≤1.5 × ULN (≤3 × ULN if due to underlying malignancy or Gilbert's).
- Karnofsky performance score ≥70.
- Expected survival >60 days.
- Central venous catheter line in place before study treatment.
- 8/8 HLA-matched related or unrelated donor (HLA-A, HLA-B, HLA-C, DRB1).
- Women of childbearing potential must be surgically sterile or use acceptable contraception through 1-year post-transplant.
- Men with partners of childbearing potential must be surgically sterile or use acceptable contraception through 12 weeks after last dose.
- Able to understand procedures, provide informed consent, and comply with study requirements.
Who cannot join
- Positive human anti-mouse antibody (HAMA) at screening.
- >20% leukemic blasts in marrow.
- Prior radiation to maximally tolerated levels of any critical organ.
- Active CNS leukemia (blasts in CSF or CNS chloromas).
- Prior allogeneic or autologous HSCT.
- Candidates suitable for myeloablative conditioning.
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- Clinically significant cardiac disease, including: NYHA Class III or IV heart failure, Clinically significant arrhythmias (ventricular tachycardia, ventricular fibrillation, Torsade de Pointes), Myocardial infarction with uncontrolled angina within 6 months, Clinically significant congestive heart failure or cardiomyopathy
- QTcF >450 ms after correction of electrolytes (unless paced rhythm or investigator deems eligible; cardiology consult optional).
- Positive HIV, HBV, or HCV test (exceptions: vaccinated HBV, or positive hepatitis markers with adequate organ function).
- Active, uncontrolled infection.
- Acute promyelocytic leukemia (t[15;17]).
- Active malignancy within 2 years, except: Myelodysplastic syndrome, Treated non-melanoma skin cancer, Completely resected stage 0-1 melanoma (>1 year from resection), Carcinoma in situ or cervical intraepithelial neoplasia, Organ-confined prostate cancer without progression
- Inability to tolerate diagnostic or therapeutic procedures, particularly radiation isolation.
- Received anti-leukemic therapy within 14 days prior to randomization (hydroxyurea allowed up to day of 131I-apamistamab).
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: An Adaptive, Operationally Seamless Phase II / III Study of 131I-apamistamab-Led Allogeneic Hematopoietic Stem Cell Transplant in Patients With Relapsed or Refractory Acute Myeloid Leukemia With Active Disease
This is a multicenter, open-label study in people aged 18 and older with relapsed or refractory acute myeloid leukemia. It has two parts. In Phase 2, we are testing three radiation dose levels of 131I-apamistamab combined with fludarabine and low-dose whole-body radiation before stem cell transplant to find the safest and most effective dose. In Phase 3, patients will be randomly assigned to receive either this treatment combination or a standard of care regimen before transplant. The main goal is to see if the new approach helps people live longer. Phase 2 will enroll about 60 people, and Phase 3 will enroll about 246 people.
Read the detailed description
This trial consists of a Phase 2 randomized dose optimization component and a Phase 3 randomized, controlled two-arm component. This is a multicenter, open-label, study of 131I-apamistamab, fludarabine and TBI, which will be compared to standard of care regimen prior to HSCT in the Phase 3 portion, in subjects, aged 18 years old or greater, with active, relapsed or refractory AML. Active, relapsed or refractory AML is defined as any one of the following: (1) primary induction failure (PIF) after 2 or more cycles of therapy, or (2) first early relapse after a remission duration of fewer than 6 months, or (3) relapse refractory to salvage combination therapy, or (4) second or subsequent relapse.
All subjects will undergo screening prior to randomization in the study. Screening will include collection of informed consent, physical examination, review of inclusion/exclusion criteria with associated testing, summarizing documented history of AML and any other malignant disease, and identification and medical clearance of an appropriate allogeneic hematopoietic stem cell (HSC) donor.
Subjects must have active R/R AML with 5-20% blasts in marrow, documented CD45 expression, ≥18 years of age, not suitable for a myeloablative conditioning regimen, Karnofsky ≥70, and a medically cleared 8/8 matched HSC donor. Key exclusions include >20% marrow blasts, prior HSCT, prior maximal organ radiation, active CNS leukemia, significant cardiac disease, abnormal QTcF >450 ms, uncontrolled infection, or active malignancy within 2 years
- Conditions
- Acute Leukemia, Myeloid Leukemia, Acute Myelogenous Leukemia, Acute Myeloid Leukemia, Acute Myeloid Leukemia, in Relapse, Myelogenous Leukemia
- Being tested
- 131I-apamistamab, Fludarabine, Cyclophosphamide, Total Body Irradiation (TBI), Allogeneic Hematopoietic Stem Cell Transplant (HSCT)
- Keywords
- Acute Myeloid Leukemia, Leukemia, Acute Myeloid, Acute Bone Marrow Cell Transplant, Transplant, Bone Marrow HCT, Refractory AML, Relapsed AML, I-131, Iomab, I131- Apamistamab, Iodine, Iodine-131, 131-I AML, Iomab-B, Radioimmunotherapy, Allogeneic Transplant, Radiotherapy, CD45, Anti-CD45 antibody
- Medical subject headings
- Leukemia, Myeloid, Leukemia, Myeloid, Acute, Leukemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
131I-apamistamabDrug
Iodine-131 radiolabeled anti-CD45 monoclonal antibody (apamistamab). Administered IV as a dosimetric dose followed by treatment dose.
FludarabineDrug
Fludarabine phosphate, 30 mg/m² IV daily on Days -6 through -2.
CyclophosphamideDrug
Cyclophosphamide
Total Body Irradiation (TBI)Radiation
TBI, 200 cGy on Day -1 prior to HSCT.
Allogeneic Hematopoietic Stem Cell Transplant (HSCT)Biological
Unmodified, G-CSF-mobilized donor stem cells infused on Day 0.
| Study group | Role | What they receive |
|---|---|---|
| Arm A: Experimental: I131-apamistamab + Fludarabine + TBI | Experimental | Participants receive a dosimetric dose and then a treatment dose of I131-apamistamab (at the marrow dose selected in Phase 2), followed by fludarabine 30 mg/m² IV daily on Days -6 through -2 and total body irradiation (TBI) 200 cGy on Day -1 prior to allogeneic hematopoietic stem cell transplant (HSCT) on Day 0.
Graft-versus-host disease (GvHD) prophylaxis per investigator's choice:
* Post-transplant cyclophosphamide (50 mg/kg on Days +3 and +4) + tacrolimus + mycophenolate mofetil, OR
* Low-dose methotrexate + tacrolimus. Receives: Drug: 131I-apamistamab; Drug: Fludarabine; Drug: Cyclophosphamide; Radiation: Total Body Irradiation (TBI); Biological: Allogeneic Hematopoietic Stem Cell Transplant (HSCT) |
| Arm B: Active Comparator - Standard of Care Conditioning Regimen | Active comparator | Participants receive standard of care conditioning regimen prior to allogeneic hematopoietic stem cell transplant (HSCT) on Day 0
GvHD prophylaxis per investigator's choice:
* Post-transplant cyclophosphamide (50 mg/kg on Days +3 and +4) + tacrolimus + mycophenolate mofetil, OR
* Low-dose methotrexate + tacrolimus. Receives: Drug: Fludarabine; Drug: Cyclophosphamide; Biological: Allogeneic Hematopoietic Stem Cell Transplant (HSCT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival (OS) -Phase 3
Defined as time from randomization to death from any cause. Subjects without documented death at the time of analysis will be censored at the date of last known contact.
Measured: Up to 5 years post-randomization
Complete Remission (CR) at Day 28 Post-HSCT - Phase 2
Number of subjects achieving CR by Day 28 (±3 days) post-HSCT, based on bone marrow assessment.
Measured: Day 28 post-HSCT
Incidence of Grade ≥4 Non-Hematologic Toxicity
Number and proportion of subjects developing grade ≥4 non-hematologic toxicities as graded by NCI CTCAE v5.0.
Measured: Up to 6 months post-HSCT
Secondary outcomes (11)
Event-Free Survival (EFS)
Time from randomization to relapse, treatment failure, or death from any cause, whichever occurs first.
Measured: Up to 5 years post-randomization
Relapse-Free Survival (RFS)
Probability of being alive without previous relapse of disease among subjects who achieve a post-transplant CR or CRi.
Measured: 6 months post-HSCT and up to 5 years post-randomization
Overall Response Rate (ORR)
Proportion of subjects achieving complete remission (CR) or complete remission with incomplete hematologic recovery (CRi) following transplant
Measured: Day 28 post-HSCT and up to 12 months
Duration of Remission (DOR)
Time from first documented CR or CRi until relapse or death from any cause.
Measured: Up to 5 years post-randomization
GvHD-Free Relapse-Free Survival (GRFS)
Composite endpoint defined as time from HSCT to first event of grade III-IV acute GvHD, chronic GvHD requiring systemic therapy, relapse, or death.
Measured: Up to 5 years post-HSCT
Survival Rate at One and Two Years Post-Transplant
Proportion of subjects alive at one year and two years following HSCT.
Measured: 1 year and 2 years post-HSCT
Engraftment
Number of subjects achieving ≥95% donor cell engraftment by Day 100 post-HSCT.
Measured: Day 100 post-HSCT
Time to Engraftment
Days from HSCT (Day 0) until subject reaches ≥95% donor cell engraftment.
Measured: Up to Day 100 post-HSCT
Incidence of Acute and Chronic GvHD
Number and proportion of subjects developing acute or chronic GvHD, summarized by severity.
Measured: 6 months post-HSCT
Relapse-Free Survival (RFS)
Probability of being alive without relapse at 180 days among subjects achieving CR/CRi.
Measured: 6 months post-HSCT
Overall Survival
Time from enrollment to death from any cause.
Measured: Up to 2 years post-enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2025
- Study startJan 2026 (estimated)
- Primary completionFeb 2029 (estimated)
- Study completionFeb 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute LeukemiaStudies of the same condition, open and under way.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Adaptive, seamless Phase 2/3 design including Phase 2 randomized dose optimization followed by a Phase 3 randomized, controlled two-arm comparison of 131I-apamistamab conditioning versus control regimen.
- Masking
- None (open label)
- Enrolment
- 306 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Actinium Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07157514
- Sponsor's protocol ID
- AIM-300
- Status last verified
- Sep 2025
- First submitted
- 28 Aug 2025
- Last updated
- 10 Sep 2025
- 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 10 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Adaptive, Operationally Seamless Phase II / III Study of 131I-apamistamab-Led Allogeneic Hematopoietic Stem Cell Transplant in Patients With Relapsed or Refractory Acute Myeloid Leukemia With Active Disease
- ClinicalTrials.gov ID
- NCT07157514
- Acronym / sponsor ID
- AIM-300
- Conditions
- Acute Leukemia, Myeloid Leukemia, Acute Myelogenous Leukemia, Acute Myeloid Leukemia, Acute Myeloid Leukemia, in Relapse, Myelogenous Leukemia
- Keywords
- Acute Myeloid Leukemia, Leukemia, Acute Myeloid, Acute Bone Marrow Cell Transplant, Transplant, Bone Marrow HCT, Refractory AML, Relapsed AML
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 306 participants (estimated)
- Lead sponsor
- Actinium PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jan 2026 (estimated)
- Primary completion
- Feb 2029 (estimated)
- Study completion
- Feb 2034 (estimated)
- First posted
- 5 Sep 2025 (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.
This is a multicenter, open-label study in people aged 18 and older with relapsed or refractory acute myeloid leukemia. It has two parts. In Phase 2, we are testing three radiation dose levels of 131I-apamistamab combined with fludarabine and low-dose whole-body radiation before stem cell transplant to find the safest and most effective dose. In Phase 3, patients will be randomly assigned to receive either this treatment combination or a standard of care regimen before transplant. The main goal is to see if the new approach helps people live longer. Phase 2 will enroll about 60 people, and Phase 3 will enroll about 246 people.
Detailed description
This trial consists of a Phase 2 randomized dose optimization component and a Phase 3 randomized, controlled two-arm component. This is a multicenter, open-label, study of 131I-apamistamab, fludarabine and TBI, which will be compared to standard of care regimen prior to HSCT in the Phase 3 portion, in subjects, aged 18 years old or greater, with active, relapsed or refractory AML. Active, relapsed or refractory AML is defined as any one of the following: (1) primary induction failure (PIF) after 2 or more cycles of therapy, or (2) first early relapse after a remission duration of fewer than 6 months, or (3) relapse refractory to salvage combination therapy, or (4) second or subsequent relapse.
All subjects will undergo screening prior to randomization in the study. Screening will include collection of informed consent, physical examination, review of inclusion/exclusion criteria with associated testing, summarizing documented history of AML and any other malignant disease, and identification and medical clearance of an appropriate allogeneic hematopoietic stem cell (HSC) donor.
Subjects must have active R/R AML with 5-20% blasts in marrow, documented CD45 expression, ≥18 years of age, not suitable for a myeloablative conditioning regimen, Karnofsky ≥70, and a medically cleared 8/8 matched HSC donor. Key exclusions include >20% marrow blasts, prior HSCT, prior maximal organ radiation, active CNS leukemia, significant cardiac disease, abnormal QTcF >450 ms, uncontrolled infection, or active malignancy within 2 years
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Adaptive, seamless Phase 2/3 design including Phase 2 randomized dose optimization followed by a Phase 3 randomized, controlled two-arm comparison of 131I-apamistamab conditioning versus control regimen.
| Arm | Type | Receives |
|---|---|---|
| Arm A: Experimental: I131-apamistamab + Fludarabine + TBI | Experimental | Drug: 131I-apamistamab, Drug: Fludarabine, Drug: Cyclophosphamide, Radiation: Total Body Irradiation (TBI), Biological: Allogeneic Hematopoietic Stem Cell Transplant (HSCT)Participants receive a dosimetric dose and then a treatment dose of I131-apamistamab (at the marrow dose selected in Phase 2), followed by fludarabine 30 mg/m² IV daily on Days -6 through -2 and total body irradiation (TBI) 200 cGy on Day -1 prior to allogeneic hematopoietic stem cell transplant (HSCT) on Day 0. Graft-versus-host disease (GvHD) prophylaxis per investigator's choice: * Post-transplant cyclophosphamide (50 mg/kg on Days +3 and +4) + tacrolimus + mycophenolate mofetil, OR * Low-dose methotrexate + tacrolimus. |
| Arm B: Active Comparator - Standard of Care Conditioning Regimen | Active comparator | Drug: Fludarabine, Drug: Cyclophosphamide, Biological: Allogeneic Hematopoietic Stem Cell Transplant (HSCT)Participants receive standard of care conditioning regimen prior to allogeneic hematopoietic stem cell transplant (HSCT) on Day 0 GvHD prophylaxis per investigator's choice: * Post-transplant cyclophosphamide (50 mg/kg on Days +3 and +4) + tacrolimus + mycophenolate mofetil, OR * Low-dose methotrexate + tacrolimus. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Have active, relapsed, or refractory AML with ≥5% and ≤20% blasts in the marrow.
- 2R/R AML is defined as one of the following: Primary induction failure after ≥2 cycles of therapy, first early relapse after remission <6 months, relapse refractory to salvage combination therapy or second or subsequent relapse
- Documented CD45 expression by leukemic cells via flow cytometry.
- ≥18 years of age and not suitable for myeloablative conditioning regimen.
- Circulating blast count <10,000/mm³ (hydroxyurea allowed).
Key exclusion criteria (14 listed)
- Positive human anti-mouse antibody (HAMA) at screening.
- >20% leukemic blasts in marrow.
- Prior radiation to maximally tolerated levels of any critical organ.
- Active CNS leukemia (blasts in CSF or CNS chloromas).
- Prior allogeneic or autologous HSCT.
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 |
|---|---|---|
| 131I-apamistamabIodine-131 radiolabeled anti-CD45 monoclonal antibody (apamistamab). Administered IV as a dosimetric dose followed by treatment dose. | Drug | Arm A: Experimental: I131-apamistamab + Fludarabine + TBI |
| FludarabineFludarabine phosphate, 30 mg/m² IV daily on Days -6 through -2. | Drug | Arm A: Experimental: I131-apamistamab + Fludarabine + TBI, Arm B: Active Comparator - Standard of Care Conditioning Regimen |
| CyclophosphamideCyclophosphamide | Drug | Arm A: Experimental: I131-apamistamab + Fludarabine + TBI, Arm B: Active Comparator - Standard of Care Conditioning Regimen |
| Total Body Irradiation (TBI)TBI, 200 cGy on Day -1 prior to HSCT. | Radiation | Arm A: Experimental: I131-apamistamab + Fludarabine + TBI |
| Allogeneic Hematopoietic Stem Cell Transplant (HSCT)Unmodified, G-CSF-mobilized donor stem cells infused on Day 0. | Biological | Arm A: Experimental: I131-apamistamab + Fludarabine + TBI, Arm B: Active Comparator - Standard of Care Conditioning Regimen |
Primary outcome
Overall Survival (OS) -Phase 3
Time frame: Up to 5 years post-randomization
Defined as time from randomization to death from any cause. Subjects without documented death at the time of analysis will be censored at the date of last known contact.
Complete Remission (CR) at Day 28 Post-HSCT - Phase 2
Time frame: Day 28 post-HSCT
Number of subjects achieving CR by Day 28 (±3 days) post-HSCT, based on bone marrow assessment.
Incidence of Grade ≥4 Non-Hematologic Toxicity
Time frame: Up to 6 months post-HSCT
Number and proportion of subjects developing grade ≥4 non-hematologic toxicities as graded by NCI CTCAE v5.0.
11 secondary outcomes
Event-Free Survival (EFS)
Time frame: Up to 5 years post-randomization
Relapse-Free Survival (RFS)
Time frame: 6 months post-HSCT and up to 5 years post-randomization
Overall Response Rate (ORR)
Time frame: Day 28 post-HSCT and up to 12 months
Duration of Remission (DOR)
Time frame: Up to 5 years post-randomization
GvHD-Free Relapse-Free Survival (GRFS)
Time frame: Up to 5 years post-HSCT
Survival Rate at One and Two Years Post-Transplant
Time frame: 1 year and 2 years post-HSCT
Engraftment
Time frame: Day 100 post-HSCT
Time to Engraftment
Time frame: Up to Day 100 post-HSCT
Incidence of Acute and Chronic GvHD
Time frame: 6 months post-HSCT
Relapse-Free Survival (RFS)
Time frame: 6 months post-HSCT
Overall Survival
Time frame: Up to 2 years post-enrollment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2025.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing 131I-apamistamab, Fludarabine and Cyclophosphamide in people with Acute Leukemia and Myeloid Leukemia, run by Actinium Pharmaceuticals.
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 10 Sep 2025. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Madhuri Vusirikala, MD (347-814-2268, mvusirikala@actiniumpharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival (OS) -Phase 3 (time frame: Up to 5 years post-randomization). The study lists 3 primary outcomes in all. 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 10 Sep 2025.