NCT04227847 A Safety Study of SEA-CD70 in Patients With Myeloid Malignancies
| NCT ID | NCT04227847 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Seagen, a wholly owned subsidiary of Pfizer |
| Condition | Myelodysplastic Syndrome |
| Study Type | INTERVENTIONAL |
| Enrollment | 178 participants |
| Start Date | 2020-08-07 |
| Primary Completion | 2027-07-04 |
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 178 participants in total. It began in 2020-08-07 with a primary completion date of 2027-07-04.
⚠ 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
This trial will look at a drug called SEA-CD70 with and without azacitidine, to find out if it is safe for participants with myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML). It will study SEA-CD70 to find out what its side effects are and if it works for AML and MDS. A side effect is anything the drug does besides treating cancer. This study will have seven groups or "parts." * Part A will find out how much SEA-CD70 should be given to participants * Part B will use the dose found in Part A to find out how safe SEA-CD70 is and if it works to treat participants with MDS. * Part C will use the dose found in Part A to find out how safe SEA-CD70 is and if it works to treat participants with AML. * Part D will find out how much SEA-CD70 with azacitidine should be given to participants * Part E will use the dose found in Part D to find out how safe SEA-CD70 with azacitidine is and if it works to treat participants with MDS or MDS/AML that has not been treated. * Part F will use the dose found in Part D to find out how safe SEA-CD70 with azacitidine is and if it works to treat participants with MDS or MDS/AML. * Part G will find out how much SEA-CD70 with azacitidine and with venetoclax should be given to participants with AML. Also, to evaluate safety and tolerability of PF-08046040 in combination with azacitidine and venetoclax in participants with previously untreated AML who are unfit for standard induction chemotherapy.
Eligibility Criteria
Part A Inclusion Criteria * Participants with cytologically/histologically confirmed MDS (2016 World Health Organization (WHO) classification) with * Measurable disease per WHO MDS with excess blasts criteria * MDS that is relapsed or refractory and must not have other therapeutic options * Treatment failure after prior hypomethylating agent (HMA) therapy for MDS * Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 Part B Inclusion Criteria * Participants with cytologically/histologically confirmed MDS (WHO classification) with: * Measurable disease per WHO MDS with excess blasts (MDS-EB) criteria * MDS that is relapsed or refractory and must not have other therapeutic options * Treatment failure after prior HMA therapy for MDS * ECOG Performance Status of 0-2 Part C Inclusion Criteria * Participants with relapsed or refractory AML (ICC 2022) (except for acute promyelocytic leukemia \[APL\]): * Who have received either 2 or 3 previous regimens * Who have received 1 previous regimen to treat active disease and have at least one of the following: * Age \> 60 and ≤75 years. * Primary resistant AML or secondary AML * First CR duration \<6 months * Adverse-risk per European Leukemia Network genetic risk stratification * Age 18-75 years * ECOG performance status of 0-2 Parts D and F Inclusion Criteria * Participants with diagnosis of MDS or MDS/AML (ICC 2022 criteria) * Disease which has relapsed, failed to respond after minimum of 6 cycles, or progressed following an HMA in the immediately preceding line of therapy. * Eligible for continued therapy with azacitidine * ECOG Performance Status 0-2 Parts D and E Inclusion Criteria * Participants with diagnosis of MDS or MDS/AML (ICC 2022 criteria), previously untreated. * Participants with higher-risk per IPSS-M MDS and MDS/AML * ECOG Performance Status 0-2 Part G Inclusion Criteria * Participants with diagnosis of AML (ICC 2022 criteria), previously untreated and ineligible for standard induction chemotherapy. * Age ≥18 years. * ECOG Performance Status of 0-2. Exclusion Criteria (All Parts) * Previous exposure to CD70-targeted agents * Prior allogeneic hematopoietic stem cell transplant, for any condition * Central nervous system leukemia * History of clinically significant sickle cell anemia, autoimmune hemolytic anemia, or idiopathic thrombocytopenic purpura * Parts D, F and G only: Prior oral HMA or oral HMA-combinations * Part G: conditions that preclude enteral route of administration; concomitant use of strong/moderate CYP3A inducers; history of myeloproliferative neoplasm
Contact & Investigator
Pfizer CT.gov Call Center
STUDY DIRECTOR
Pfizer
Frequently Asked Questions
Who can join the NCT04227847 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Myelodysplastic Syndrome. 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 NCT04227847 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 NCT04227847 currently recruiting?
Yes, NCT04227847 is actively recruiting participants. Contact the research team at ClinicalTrials.gov_Inquiries@pfizer.com for enrollment information.
Where is the NCT04227847 trial being conducted?
This trial is being conducted at Birmingham, United States, Birmingham, United States, Birmingham, United States, Duarte, United States and 11 additional locations.
Who is sponsoring the NCT04227847 clinical trial?
NCT04227847 is sponsored by Seagen, a wholly owned subsidiary of Pfizer. The principal investigator is Pfizer CT.gov Call Center at Pfizer. The trial plans to enroll 178 participants.