First-in-Human Dose Escalation Study of AFM28 in Patients With Relapsed/Refractory Acute Myeloid Leukemia
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ClinicalTrials.gov Identifier: NCT05817058 |
Recruitment Status :
Recruiting
First Posted : April 18, 2023
Last Update Posted : March 13, 2024
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Condition or disease | Intervention/treatment | Phase |
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Acute Myeloid Leukemia | Drug: AFM28 | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 50 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase 1 Multicenter, Open Label, First-in-Human Dose Escalation Study of AFM28, a Bispecific ICE® That Targets CD123 and CD16A, in Patients With CD123-Positive Relapsed/Refractory Acute Myeloid Leukemia |
Actual Study Start Date : | March 21, 2023 |
Estimated Primary Completion Date : | March 2025 |
Estimated Study Completion Date : | March 2026 |
Arm | Intervention/treatment |
---|---|
Experimental: Treatment of escalating doses of AFM28
AFM28 first in human starting dose will be 25 mg i.v.
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Drug: AFM28
AFM28 dose escalation |
- The Incidence of dose limiting toxicities [ Time Frame: 28 days following the first dose of study treatment ]
The incidence of dose limiting toxicities during dose limiting toxicities observation period considering the totality of treatment-emergent adverse events is evaluated using
- National Cancer Institute Common Terminology Criteria for Adverse Events, v5.0
- the American Society of Transplantation and Cellular Therapy Cytokine Release Syndrome grading system for Cytokine Release Syndrome
- the Cairo-Bishop Tumor Lysing Syndrom (TLS) grading system for TLS
- Incidence and severity of Treatment Emergent Adverse Events [ Time Frame: through study completion (up to 36 weeks) ]Incidence and severity of Treatment Emergent Adverse Events
- Incidence and severity of Serious Adverse Events [ Time Frame: through study completion (up to 36 weeks) ]Incidence and severity of Serious Adverse Events
- Incidence of subjects developing anti-drug antibodies [ Time Frame: through study completion (up to 36 weeks) ]Incidence of anti-drug antibodies during treatment with AFM28 (by measurement of anti-drug antibodies before and throughout treatment with AFM28)
- Area under the concentration-time curve [ Time Frame: cycle 1 (day 1 and day 28) ]Area under the concentration-time curve over the dose interval
- Cmax [ Time Frame: cycle 1 (day 1 and day 28) ]Maximum observed plasma concentration
- Tmax [ Time Frame: cycle 1 (day 1 and day 28) ]Time to reach maximum observed plasma concentration
- Ctrough [ Time Frame: immediately prior to the fourth dose ]Concentration measured immediately prior to the fourth dose
- Complete Response [ Time Frame: Through treatment period until 14 days after last dose ]Complete response (Disease assessment in accordance with the International Working Group (IWG) criteria for AML and the European Leukemia Network (ELN) 2017 classification criteria)
- Complete Response hematological [ Time Frame: Through treatment period until 14 days after last dose ]Complete Response with partial hematologic recovery (Disease assessment in accordance with the IWG criteria for AML and the ELN 2017 classification criteria)
- Complete Response composite rate [ Time Frame: Through treatment period until 14 days after last dose ]Composite complete response rate (Disease assessment in accordance with the IWG criteria for AML and the ELN 2017 classification criteria)
- Complete Response + Complete Response hematological rate [ Time Frame: Through treatment period until 14 days after last dose ]Complete Response plus Complete Response with partial hematologic recovery rate (Disease assessment in accordance with the IWG criteria for AML and the ELN 2017 classification criteria)
- Overall Response Rate [ Time Frame: Through treatment period until 14 days after last dose ]Overall response rate (Disease assessment in accordance with the IWG criteria for AML and the ELN 2017 classification criteria)
- Disease Control Rate [ Time Frame: Through treatment period until 14 days after last dose ]Disease control rate (Disease assessment in accordance with the IWG criteria for AML and the ELN 2017 classification criteria)
- Duration of Response [ Time Frame: Through treatment period until 14 days after last dose ]Duration of Response (Disease assessment in accordance with the IWG criteria for AML and the ELN 2017 classification criteria)
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
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1. Subjects with a confirmed diagnosis of AML as defined by 2016 WHO Classification and determined by pathology review at the study site. Subjects with acute promyelocytic leukemia are excluded.
2. Subjects must have CD123-positive AML confirmed on bone marrow or peripheral blood at Screening (assessed locally without any cut-off level).
3. Subjects with AML who are in the first, second, or third relapse OR who are at least primary refractory and received at most 3 regimes of previous standard anti-leukemia therapy.
4. Primary refractory is defined as ≥ 5% blasts in bone marrow following 2 cycles of anthracycline and cytarabine based induction (such as 3+7 or similar), or one cycle of purine analogue containing induction, or after ≥ 3 cycles hypomethylating agent ± or low dose cytarabine ± B-Cell lymphoma 2 based induction regimen, or ≥ 4 cycles of hypomethylating agent based therapy.
5. Subjects with prior autologous and allogeneic bone marrow transplant are eligible. Subjects with an allogeneic transplant must meet the following conditions: The transplant must have been performed > 3 months before the date of dosing on this study, the subject must not have active graft versus host disease, must be off all graft versus host disease medications at least > 28 days prior to date of dosing of study drug (for example, calcineurin inhibitors, ≥ 10 mg/day prednisone or other steroid equivalent, or other immunosuppressive agents).
Exclusion Criteria:
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1. Diagnosis of BCR-ABL-positive leukemia, acute promyelocytic leukemia, or juvenile myelomonocytic leukemia.
2. Known hypersensitivity/allergic reaction ≥ grade 3 to monoclonal antibodies or any components used in the AFM28 drug product preparation, any history of anaphylaxis or uncontrolled asthma. Prior CD123 targeting therapies should be allowed after discussion with and at the discretion of the Sponsor.
3. Received any anticancer therapy or investigational treatment for AML within 14 days of the first dose of study drug and within 28 days for biological agents including but not limited to monoclonal antibodies, cellular therapies, bispecific antibodies, checkpoint antibodies and others. Must have recovered to grade ≤ 1 from any grade 2 to 4 toxicity from previous treatment, except alopecia.
4. History of any other systemic malignancy, unless previously treated with curative intent and the subject has been disease free for 2 years or longer. Examples for acceptable previous malignancies include completely removed in situ cervical intra-epithelial neoplasia, non-melanoma skin cancer, ductal carcinoma in situ, early-stage prostate cancer that has been adequately treated. Subjects who meet the above criteria and are on maintenance therapy for the prior malignancy may be eligible after discussion and approval from the medical monitor.
5. The subject has received radionuclide treatment within 6 weeks of the first dose of study treatment.
6. Known clinically active or suspected central nervous system (CNS) leukemia. If suspected, CNS leukemia should be ruled out with relevant imaging and/or examination of cerebrospinal fluid. Subjects with known prior CNS leukemia should have had at least two consecutive negative Lumbar Punctures for CNS leukemia and no clinical signs.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05817058
Contact: Affimed GmbH | +49 6221 6743 ext 60 | trials@affimed.com |
Denmark | |
Rigshospitalet | Withdrawn |
Copenhagen, Denmark, DK-2100 | |
France | |
Institut Universitaire du Cancer Toulouse - Oncopole | Recruiting |
Toulouse, France, 31059 | |
Contact: Christian Récher | |
Gustave Roussy | Recruiting |
Villejuif Cedex, France, 94805 | |
Contact: Stephane De Botton, MD | |
Spain | |
Institut Català d'Oncologia-Hospital Duran i Reynals | Recruiting |
Barcelona, Spain, 08907 | |
Contact: Montserrat Arnan Sangerman, MD, PhD | |
Hospital Universitario 12 de Octubre | Recruiting |
Madrid, Spain, 28041 | |
Contact: Maria Calbacho Robles, MD | |
Hospital Universitari i Politècnic La Fe | Recruiting |
Valencia, Spain, CP 46026 | |
Contact: Pau Montesinos, MD |
Study Director: | Lydia Wunderle | Affimed GmbH |
Responsible Party: | Affimed GmbH |
ClinicalTrials.gov Identifier: | NCT05817058 |
Other Study ID Numbers: |
AFM28-101 |
First Posted: | April 18, 2023 Key Record Dates |
Last Update Posted: | March 13, 2024 |
Last Verified: | March 2024 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute |
Neoplasms by Histologic Type Neoplasms Hematologic Diseases |