--- title: A Safety Study of SEA-CD70 in Patients With Myeloid Malignancies nct_id: NCT04227847 overall_status: RECRUITING phase: PHASE1 sponsor: Seagen, a wholly owned subsidiary of Pfizer study_type: INTERVENTIONAL primary_condition: Myelodysplastic Syndrome countries: United States, Japan, Netherlands canonical_url: "https://parkinsonspathways.com/agent/trials/NCT04227847.md" clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT04227847" ct_last_update_post_date: 2026-04-07 last_seen_at: "2026-05-12T07:30:01.685Z" source: ClinicalTrials.gov (mirrored, no enrichment) --- # A Safety Study of SEA-CD70 in Patients With Myeloid Malignancies **Official Title:** A Phase 1 Study of SEA-CD70 in Myeloid Malignancies **NCT ID:** [NCT04227847](https://clinicaltrials.gov/study/NCT04227847) ## Key Facts - **Status:** RECRUITING - **Phase:** PHASE1 - **Study Type:** INTERVENTIONAL - **Target Enrollment:** 178 - **Lead Sponsor:** Seagen, a wholly owned subsidiary of Pfizer - **Conditions:** Myelodysplastic Syndrome, Acute Myeloid Leukemia - **Start Date:** 2020-08-07 - **Completion Date:** 2028-07-03 - **CT.gov Last Update:** 2026-04-07 ## 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. ## Detailed Description This is a phase 1, open-label, multicenter, dose-finding, and dose expansion study designed to evaluate the safety, tolerability, pharmacokinetics (PK), and antitumor activity of SEA-CD70 monotherapy and SEA-CD70 in combination with azacitidine in adults with myeloid malignancies. The study will be conducted in up to 6 parts. * Part A is a dose-escalation cohort designed to identify the MTD or recommended expansion dose of SEA-CD70 monotherapy in participants with relapsed/refractory (hypomethylating agent \[HMA\]-failure) MDS. * Part B is an expansion cohort designed to evaluate the safety and tolerability of SEA-CD70 monotherapy in participants with relapsed/refractory (HMA-failure) MDS. * Part C is an expansion cohort designed to evaluate the safety and tolerability of SEA-CD70 monotherapy in participants with relapsed/refractory AML. * Part D contains dose-finding/dose optimization cohorts designed to evaluate the safety/tolerability and identify the recommended expansion dose of SEA-CD70 in combination with azacitidine in participants with 1) relapsed/refractory (HMA-failure) MDS or MDS/AML, and 2) previously untreated higher-risk per IPSS-M (Moderate High, High or Very High) MDS or MDS/AML. * Part E is an expansion cohort designed to evaluate the safety and tolerability of SEA-CD70 in combination with azacitidine in participants with previously untreated higher-risk per IPSS-M (Moderate High, High, or Very High) MDS or MDS/AML. * Part F is an expansion cohort designed to evaluate the safety and tolerability of SEA-CD70 in combination with azacitidine in participants with relapsed/refractory (HMA-failure) MDS or MDS/AML. * Part G will find out how much SEA-CD70 with azacitidine and with venetoclax should be given to participants with previously untreated AML who are unfit for standard of care induction chemotherapy ## Eligibility - **Minimum age:** 18 Years - **Sex:** ALL - **Healthy Volunteers:** No ``` 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 ``` ## Arms - **Part A** (EXPERIMENTAL) — SEA-CD70 dose escalation cohort in relapsed/refractory (HMA-failure) MDS - **Part B** (EXPERIMENTAL) — SEA-CD70 expansion cohort in relapsed/refractory (HMA-failure) MDS - **Part C** (EXPERIMENTAL) — SEA-CD70 expansion cohort in relapsed/refractory AML - **Part D** (EXPERIMENTAL) — SEA-CD70 + azacitidine dose-finding/dose optimization cohorts in relapsed/refractory MDS or MDS/AML, and previously untreated higher-risk MDS or MDS/AML - **Part E** (EXPERIMENTAL) — SEA-CD70 + azacitidine expansion cohort in previously untreated higher-risk MDS or MDS/AML - **Part F** (EXPERIMENTAL) — SEA-CD70 + azacitidine expansion cohort in relapsed/refractory MDS or MDS/AML - **Part G** (EXPERIMENTAL) — SEA-CD70 + azacitidine +venetoclax dose-finding/dose optimization in previously untreated and unfit for induction therapy AML ## Interventions - **SEA-CD70** (DRUG) — Given into the vein (IV; intravenously) on Days 1 and 15 of each treatment cycle - **azacitidine** (DRUG) — 75mg/m\^2 injected under the skin (SC; subcutaneous) or given into the vein (IV; intravenously) on Days 1 through 7 of each treatment cycle. - **Venetoclax** (DRUG) — 400 mg /day PO, continuously; administered with ramping ## Primary Outcomes - **Number of participants with adverse events (AEs)** _(time frame: Through 30-37 days following last dose of SEA-CD70; up to approximately 2 years)_ — Any untoward medical occurrence in a clinical investigational participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment. - **Number of participants with laboratory abnormalities** _(time frame: Through 30-37 days following last dose of SEA-CD70; up to approximately 2 years)_ — To be summarized using descriptive statistics. - **Number of participants with a dose-limiting toxicity (DLT) at each dose level (Parts A and D only)** _(time frame: Though end of DLT evaluation period; up to approximately 4 weeks)_ — To be summarized using descriptive statistics. ## Secondary Outcomes - **AUC - Area under the plasma concentration-time curve** _(time frame: Through 30-37 days following last dose of SEA-CD70; up to approximately 2 years)_ - **Tmax - Time to maximum concentration attained** _(time frame: Through 30-37 days following last dose of SEA-CD70; up to approximately 2 years)_ - **Cmax - Maximum observed plasma concentration** _(time frame: Through 30-37 days following last dose of SEA-CD70; up to approximately 2 years)_ - **Ctrough - Minimum plasma concentration per dosing interval** _(time frame: Through 30-37 days following last dose of SEA-CD70; up to approximately 2 years)_ - **T1/2 - Terminal elimination half-life** _(time frame: Through 30-37 days following last dose of SEA-CD70; up to approximately 2 years)_ - **Incidence of antidrug antibodies (ADA)** _(time frame: Through 30-37 days following last dose of SEA-CD70; up to approximately 2 years)_ - **Complete remission (CR) Rate and complete remission equivalent (CReq) rate** _(time frame: Up to approximately 4 years)_ - **Complete remission with incomplete blood count recovery (CRi) rate** _(time frame: Up to approximately 4 years)_ - **Complete remission with limited count recovery (CRL) rate for participants with MDS or MDS/AML** _(time frame: Up to approximately 4 years)_ - **Complete remission with partial hematologic recovery (CRh) rate** _(time frame: Up to approximately 4 years)_ - **Hematologic response (HI) rate** _(time frame: Up to approximately 4 years)_ - **Overall response rate (ORR)** _(time frame: Up to approximately 4 years)_ - **Duration of remission (DOR)** _(time frame: Up to approximately 4 years)_ - **Overall survival (OS)** _(time frame: Up to approximately 4 years)_ - **Event-free survival (EFS)** _(time frame: Up to approximately 4 years)_ - **Progression-free survival (PFS)** _(time frame: Up to approximately 4 years)_ - **MRD-negative ORR** _(time frame: Up to approximately 4 years)_ - **Time to response (TTR)** _(time frame: Up to approximately 4 years)_ - **Rate of conversion to transfusion independence (TI)** _(time frame: Up to approximately 4 years)_ - **Rate of TI maintenance** _(time frame: Up to approximately 4 years)_ ## Locations (54) - University of Alabama at Birmingham, Birmingham, Alabama, United States — _ACTIVE_NOT_RECRUITING_ - University of Alabama at Birmingham, Birmingham, Alabama, United States — _ACTIVE_NOT_RECRUITING_ - Dept. of Medicine, UAB ONeal Comprehensive Cancer Center, Birmingham, Alabama, United States — _ACTIVE_NOT_RECRUITING_ - City of Hope (City of Hope National Medical Center, City of Hope Medical Center), Duarte, California, United States — _RECRUITING_ - IP Address: City of Hope Investigational Drug Services(IDS), Duarte, California, United States — _RECRUITING_ - Ronald Reagan UCLA Medical Center, Los Angeles, California, United States — _RECRUITING_ - UCLA Hematology-Oncology Clinic, Los Angeles, California, United States — _RECRUITING_ - Colorado Blood Cancer Institute, Lab, Denver, Colorado, United States — _ACTIVE_NOT_RECRUITING_ - Colorado Blood Cancer Institute, Denver, Colorado, United States — _ACTIVE_NOT_RECRUITING_ - Presbyterian/St. Luke's Medical Center, Denver, Colorado, United States — _ACTIVE_NOT_RECRUITING_ - The University of Kansas Cancer Center ,Investigational Drug Services, Fairway, Kansas, United States — _RECRUITING_ - The University of Kansas Clinical Research Center, Fairway, Kansas, United States — _RECRUITING_ - The University of Kansas Hospital, Kansas City, Kansas, United States — _RECRUITING_ - University of Kansas Hospital Cambridge North Tower A, Kansas City, Kansas, United States — _RECRUITING_ - University of Kansas Medical center Medical office building, Kansas City, Kansas, United States — _RECRUITING_ - University of Kansas Medical Center Research Institute, Kansas City, Kansas, United States — _RECRUITING_ - The University of Kansas Cancer Center - Overland Park, Overland Park, Kansas, United States — _RECRUITING_ - The University of Kansas Cancer Center - Indian Creek Campus, Overland Park, Kansas, United States — _RECRUITING_ - The University of Kansas Cancer Center, Westwood, Kansas, United States — _RECRUITING_ - Norton Hospitals, Inc, Louisville, Kentucky, United States — _RECRUITING_ - Norton Cancer Institute, St. Matthews Campus, Attn. Becky Champion, PharmD, Louisville, Kentucky, United States — _RECRUITING_ - Norton Cancer Institute, St. Matthews Campus, Louisville, Kentucky, United States — _RECRUITING_ - Norton Women & Children's Hospital, Louisville, Kentucky, United States — _RECRUITING_ - Massachusetts General Hospital, Boston, Massachusetts, United States — _RECRUITING_ - Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States — _RECRUITING_ - Dana Farber/Mass General Brigham Cancer Care, Inc, Boston, Massachusetts, United States — _RECRUITING_ - Karmanos Cancer Institute, Detroit, Michigan, United States — _RECRUITING_ - Karmanos Cancer Institute Weisberg Cancer Treatment Center, Farmington Hills, Michigan, United States — _RECRUITING_ - The University of Kansas Cancer Center - Medical Oncology Clinic, Kansas City, Missouri, United States — _RECRUITING_ - The University of Kansas Cancer Center - Radiation Oncology Clinic, Kansas City, Missouri, United States — _RECRUITING_ - The University of Kansas Cancer Center -North, Kansas City, Missouri, United States — _RECRUITING_ - The University of Kansas Cancer Center - Lee's Summit, Lee's Summit, Missouri, United States — _RECRUITING_ - Columbia University Irving Medical Center, New York, New York, United States — _RECRUITING_ - CUIMC Research Pharmacy, New York, New York, United States — _RECRUITING_ - The New York and Presbyterian Hospital, New York, New York, United States — _RECRUITING_ - University Hospitals Cleveland Medical Center, Cleveland, Ohio, United States — _RECRUITING_ - Cleveland Clinic, Cleveland, Ohio, United States — _RECRUITING_ - The Ohio State University Wexner Medical Center/James Cancer Hospital, Columbus, Ohio, United States — _RECRUITING_ - Hollings Cancer Center, Charleston, South Carolina, United States — _RECRUITING_ - Medical University of South Carolina- Ashley River Tower, Charleston, South Carolina, United States — _RECRUITING_ - Medical University of South Carolina- Investigational Drug Services, Charleston, South Carolina, United States — _RECRUITING_ - Medical University of South Carolina- University Hospital, Charleston, South Carolina, United States — _RECRUITING_ - Baylor Research Institute, Dallas, Texas, United States — _RECRUITING_ - Baylor University Medical Center, Investigational Drug Services, Department of Pharmacy, Dallas, Texas, United States — _RECRUITING_ - Baylor University Medical Center, Dallas, Texas, United States — _RECRUITING_ - Houston Methodist Hospital, Houston, Texas, United States — _RECRUITING_ - The University of Texas MD Anderson Cancer Center, Houston, Texas, United States — _ACTIVE_NOT_RECRUITING_ - Swedish Cancer Institute, Seattle, Washington, United States — _RECRUITING_ - Swedish Medical Center, Seattle, Washington, United States — _RECRUITING_ - National Cancer Center Hospital East, Kashiwa, Chiba, Japan — _RECRUITING_ - Nippon Medical School Hospital, Bunkyo-ku, Tokyo, Japan — _RECRUITING_ - Yamagata University Hospital, Yamagata, Japan — _RECRUITING_ - Pharmacy - UMC Utrecht t.a.v. Apotheek KGO, Utrecht, Netherlands — _RECRUITING_ - University Medical Center (UMC) Utrecht, Utrecht, Netherlands — _RECRUITING_ ## Recent Field Changes (last 30 days) - `locations.university medical center (umc) utrecht|utrecht||netherlands` — added _(2026-05-12)_ - `locations.pharmacy - umc utrecht t.a.v. apotheek kgo|utrecht||netherlands` — added _(2026-05-12)_ - `locations.yamagata university hospital|yamagata||japan` — added _(2026-05-12)_ - `locations.nippon medical school hospital|bunkyo-ku|tokyo|japan` — added _(2026-05-12)_ - `locations.national cancer center hospital east|kashiwa|chiba|japan` — added _(2026-05-12)_ - `locations.swedish medical center|seattle|washington|united states` — added _(2026-05-12)_ - `locations.swedish cancer institute|seattle|washington|united states` — added _(2026-05-12)_ - `locations.the university of texas md anderson cancer center|houston|texas|united states` — added _(2026-05-12)_ - `locations.houston methodist hospital|houston|texas|united states` — added _(2026-05-12)_ - `locations.baylor university medical center|dallas|texas|united states` — added _(2026-05-12)_ - `locations.baylor university medical center, investigational drug services, department of pharmacy|dallas|texas|united states` — added _(2026-05-12)_ - `locations.baylor research institute|dallas|texas|united states` — added _(2026-05-12)_ - `locations.medical university of south carolina- university hospital|charleston|south carolina|united states` — added _(2026-05-12)_ - `locations.medical university of south carolina- investigational drug services|charleston|south carolina|united states` — added _(2026-05-12)_ - `locations.medical university of south carolina- ashley river tower|charleston|south carolina|united states` — added _(2026-05-12)_ - `locations.hollings cancer center|charleston|south carolina|united states` — added _(2026-05-12)_ - `locations.the ohio state university wexner medical center/james cancer hospital|columbus|ohio|united states` — added _(2026-05-12)_ - `locations.cleveland clinic|cleveland|ohio|united states` — added _(2026-05-12)_ - `locations.university hospitals cleveland medical center|cleveland|ohio|united states` — added _(2026-05-12)_ - `locations.the new york and presbyterian hospital|new york|new york|united states` — added _(2026-05-12)_ - `locations.cuimc research pharmacy|new york|new york|united states` — added _(2026-05-12)_ - `locations.columbia university irving medical center|new york|new york|united states` — added _(2026-05-12)_ - `locations.the university of kansas cancer center - lee's summit|lee's summit|missouri|united states` — added _(2026-05-12)_ - `locations.the university of kansas cancer center -north|kansas city|missouri|united states` — added _(2026-05-12)_ - `locations.the university of kansas cancer center - radiation oncology clinic|kansas city|missouri|united states` — added _(2026-05-12)_ - `locations.the university of kansas cancer center - medical oncology clinic|kansas city|missouri|united states` — added _(2026-05-12)_ - `locations.karmanos cancer institute weisberg cancer treatment center|farmington hills|michigan|united states` — added _(2026-05-12)_ - `locations.karmanos cancer institute|detroit|michigan|united states` — added _(2026-05-12)_ - `locations.dana farber/mass general brigham cancer care, inc|boston|massachusetts|united states` — added _(2026-05-12)_ - `status.overallStatus` — added _(2026-05-12)_ - `status.primaryCompletionDate` — added _(2026-05-12)_ - `status.completionDate` — added _(2026-05-12)_ - `status.lastUpdatePostDate` — added _(2026-05-12)_ - `design.phases` — added _(2026-05-12)_ - `design.enrollmentCount` — added _(2026-05-12)_ - `locations.university of alabama at birmingham|birmingham|alabama|united states` — added _(2026-05-12)_ - `locations.dept. of medicine, uab oneal comprehensive cancer center|birmingham|alabama|united states` — added _(2026-05-12)_ - `eligibility.criteria` — added _(2026-05-12)_ - `eligibility.minAge` — added _(2026-05-12)_ - `eligibility.sex` — added _(2026-05-12)_ - `outcomes.primary` — added _(2026-05-12)_ - `outcomes.secondary` — added _(2026-05-12)_ - `armsInterventions.arms` — added _(2026-05-12)_ - `armsInterventions.interventions` — added _(2026-05-12)_ - `sponsor.lead` — added _(2026-05-12)_ - `results.hasResults` — added _(2026-05-12)_ - `locations.city of hope (city of hope national medical center, city of hope medical center)|duarte|california|united states` — added _(2026-05-12)_ - `locations.ip address: city of hope investigational drug services(ids)|duarte|california|united states` — added _(2026-05-12)_ - `locations.ronald reagan ucla medical center|los angeles|california|united states` — added _(2026-05-12)_ - `locations.ucla hematology-oncology clinic|los angeles|california|united states` — added _(2026-05-12)_ --- *Canonical: https://parkinsonspathways.com/agent/trials/NCT04227847.md* *Source data (authoritative): https://clinicaltrials.gov/study/NCT04227847* *This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*