NCT06424340 MB-dNPM1-TCR.1 in Relapsed/Refractory AML
| NCT ID | NCT06424340 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Miltenyi Biomedicine GmbH |
| Condition | Leukemia, Myeloid, Acute |
| Study Type | INTERVENTIONAL |
| Enrollment | 29 participants |
| Start Date | 2024-08-01 |
| Primary Completion | 2028-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 29 participants in total. It began in 2024-08-01 with a primary completion date of 2028-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this Phase I/II, single arm, prospective, open label, dose escalation trial is to assess safety, feasibility and efficacy of ex vivo expanded autologous T cells genetically modified to express a T cell receptor (TCR) specific for dNPM1 peptides restricted to human leukocyte antigen (HLA) A\*02:01 in patients with relapsed or refractory AML.
Eligibility Criteria
Inclusion Criteria: 1. Age ≥ 18 years 2. Patients must be able to understand and be willing to give signed informed consent 3. Relapsed or refractory acute myeloid leukemia (last disease staging within 4 weeks prior to screening) without standard treatment options defined as: * No morphological CR or extramedullary AML after at least two courses of intensive chemotherapy, decitabine or other standard therapy or * MRD positive after at least two courses of intensive chemotherapy or other standard therapy and not eligible for allogeneic stem cell transplantation or * Relapsed bone marrow or blood disease or extramedullary AML after CR after first line treatment and not eligible to undergo allogeneic stem cell transplantation or * Bone marrow, blood, extramedullary AML relapse or non-response or MRD positivity after allogeneic stem cell transplantation and not eligible to receive Donor Lymphocyte Infusion (DLI) according to local standards, relapse or MRD positive after DLI. 4. Positive for HLA-A\*02:01 according to genotyping results. 5. AML has NPM1 mutation which is recognized by dNPM1-TCR.1 and for which a specific Q-PCR is available for disease monitoring. 6. Number of circulating WBC above 1x109/L with less than 50% leukemic blasts and 0.03 x 109 CD8+ T cells/L. 7. Life expectancy of at least 3 months. 8. ECOG performance status 0-3. 9. Negative pregnancy test in women of childbearing potential. 10. For fertile men and women, agreement to use highly effective contraceptive methods during the trial. Exclusion Criteria: 1. Pregnant or breast feeding women. 2. Active infection with HIV-1, HIV-2, HBV, HCV, HTLV-I, HTLV-II, SARS-CoV-2 or Treponema Pallidum. 3. Any clinically significant, advanced or unstable disease or inadequate main organ function that may put the patient at increased risk for severe complications of trial participation at the discretion of the investigator. 4. Use of systemic immune suppression including, but not limited to: immunosuppressive agents such as cyclosporine or corticosteroids (at an equivalent dose of 0.5 mg prednisone/kg body weight per day, or higher). Inhaled steroid and physiological replacement for adrenal insufficiency are allowed. 5. Unwillingness or inability to comply with procedures required in this clinical trial protocol. 6. Uncontrolled life-threatening infections or uncontrolled disseminated intravascular coagulation; however, if these problems resolve, the start of treatment can be initiated on a delayed schedule. 7. Subjects currently on any other IMP (including within the last 30 days before start of treatment). 8. Current use of high dose immunosuppression for immune disorders interfering with T cell function (on discretion of the investigator). 9. Known hypersensitivity against any drug of the mandatory trial procedures. 10. Serum creatinine ≥ 2.0 × ULN or eGFR \< 30 mL/min calculated according to the modified MDRD formula. 11. BMI ≥40 12. Has received vaccination with live vaccines 6 weeks prior to treatment 13. Major surgery less than 30 days before start of treatment. 14. Committal to an institution on judicial or official order.
Contact & Investigator
C.J.M. Halkes, Dr
PRINCIPAL INVESTIGATOR
Leiden University Medical Center
Frequently Asked Questions
Who can join the NCT06424340 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Leukemia, Myeloid, Acute. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06424340 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06424340 currently recruiting?
Yes, NCT06424340 is actively recruiting participants. Contact the research team at clinicaltrials.gov@miltenyi.com for enrollment information.
Where is the NCT06424340 trial being conducted?
This trial is being conducted at Leiden, Netherlands.
Who is sponsoring the NCT06424340 clinical trial?
NCT06424340 is sponsored by Miltenyi Biomedicine GmbH. The principal investigator is C.J.M. Halkes, Dr at Leiden University Medical Center. The trial plans to enroll 29 participants.
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