A Safety Study of SEA-CD70 in Patients With Myeloid Malignancies
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ClinicalTrials.gov Identifier: NCT04227847 |
Recruitment Status :
Recruiting
First Posted : January 14, 2020
Last Update Posted : May 10, 2022
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This trial will look at a drug called SEA-CD70 to find out if it is safe for patients 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 three groups or "parts." Part A will find out how much SEA-CD70 should be given to patients. Part B will use the dose found in Part A to find out how safe SEA-CD70 is and if it works to treat patients 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 patients with AML.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Myelodyspastic Syndrome Acute Myeloid Leukemia | Drug: SEA-CD70 | Phase 1 |
This is a phase 1, open-label, multicenter, dose-escalation, and cohort expansion study designed to evaluate the safety, tolerability, PK, and antitumor activity of SEA-CD70 in adults with myeloid malignancies. The study will be conducted in up to 3 parts.
Part A is a dose escalation cohort designed to identify the MTD or recommended expansion dose of SEA-CD70 in subjects with relapsed/refractory (HMA-failure) MDS. Part B is an expansion cohort designed to evaluate the safety and tolerability of SEA-CD70 in subjects with relapsed/refractory (HMA-failure) MDS. Part C is an expansion cohort designed to evaluate the safety and tolerability of SEA-CD70 in subjects with relapsed/refractory AML.
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 60 participants |
Allocation: | Non-Randomized |
Intervention Model: | Sequential Assignment |
Intervention Model Description: | Part B and C will enroll in parallel after enrollment of Part A is complete. |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase 1 Study of SEA-CD70 in Myeloid Malignancies |
Actual Study Start Date : | August 7, 2020 |
Estimated Primary Completion Date : | November 30, 2022 |
Estimated Study Completion Date : | October 31, 2024 |

Arm | Intervention/treatment |
---|---|
Experimental: Part A
SEA-CD70 dose escalation cohort in relapsed/refractory (HMA-failure) MDS
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Drug: SEA-CD70
Given into the vein (IV; intravenously) on Days 1 and 15 of each treatment cycle |
Experimental: Part B
SEA-CD70 expansion cohort in relapsed/refractory (HMA-failure) MDS
|
Drug: SEA-CD70
Given into the vein (IV; intravenously) on Days 1 and 15 of each treatment cycle |
Experimental: Part C
SEA-CD70 expansion cohort in relapsed/refractory AML
|
Drug: SEA-CD70
Given into the vein (IV; intravenously) on Days 1 and 15 of each treatment cycle |
- 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 (Part A only) [ Time Frame: Though end of DLT evaluation period; up to approximately 4 weeks ]To be summarized using descriptive statistics.
- 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 ]To be summarized using descriptive statistics.
- Tmax - Time to maximum concentration attained [ Time Frame: Through 30-37 days following last dose of SEA-CD70; up to approximately 2 years ]To be summarized using descriptive statistics.
- Cmax - Maximum observed plasma concentration [ Time Frame: Through 30-37 days following last dose of SEA-CD70; up to approximately 2 years ]To be summarized using descriptive statistics.
- Ctrough - Minimum plasma concentration per dosing interval [ Time Frame: Through 30-37 days following last dose of SEA-CD70; up to approximately 2 years ]To be summarized using descriptive statistics.
- T1/2 - Terminal elimination half-life [ Time Frame: Through 30-37 days following last dose of SEA-CD70; up to approximately 2 years ]To be summarized using descriptive statistics.
- Incidence of antidrug antibodies (ADA) [ Time Frame: Through 30-37 days following last dose of SEA-CD70; up to approximately 2 years ]To be summarized using descriptive statistics.
- Complete remission (CR) Rate [ Time Frame: Up to approximately 4 years ]Proportion of participants with AML or MDS who achieve CR
- Complete remission with incomplete blood count recovery (CRi) rate [ Time Frame: Up to approximately 4 years ]Proportion of participants with AML who achieve CRi
- Complete remission with partial hematologic recovery (CRh) rate [ Time Frame: Up to approximately 4 years ]Proportion of participants with AML or MDS who achieve CRh
- Hematologic response (HI) rate [ Time Frame: Up to approximately 4 years ]Proportion of MDS participants with HI
- Objective response rate (ORR) [ Time Frame: Up to approximately 4 years ]For AML, the proportion of participants who achieve a best response of CR, CRi, CRh, or partial response (PR). For MDS, the proportion of participants who achieve a best response of CR, CRh, or PR.
- Blast clearance rate for participants with MDS [ Time Frame: Up to approximately 4 years ]Proportion of participants with MDS who achieve CR, PR, Marrow CR, or CRh
- Duration of response (DOR) [ Time Frame: Up to approximately 4 years ]For AML, the time from first CR, CRi, or CRh response to the first documentation of disease progression, start of new therapy, or death due to any cause. For MDS, the time from first PR, CR, or CRh to the first documentation of disease progression, start of new therapy, or death due to any cause.
- Overall survival (OS) [ Time Frame: Up to approximately 4 years ]Time from start of study treatment to the date of death due to any cause
- Event-free survival (EFS) [ Time Frame: Up to approximately 4 years ]Time from first dose to the first documentation of progression, disease relapse, or death due to any cause, whichever comes first.
- MRD-negative ORR [ Time Frame: Up to approximately 4 years ]Proporation of participants with AML or MDS who achieve MRD-negative ORR
- Time to response (TTR) [ Time Frame: Up to approximately 4 years ]Time from start of study treatment to the first documentation of objective response
- Rate of conversion to transfusion independence (TI) [ Time Frame: Up to approximately 4 years ]Proportion of participants who convert from transfusion dependence at baseline to TI post-baseline
- Maintenance of TI [ Time Frame: Up to approximately 4 years ]Number of subjects who were TI at baseline and maintain TI post-baseline

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Part A Inclusion Criteria
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Participants with cytologically/histologically confirmed myelodysplastic syndrome (MDS) according to the 2016 World Health Organization (WHO) classification with the following:
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Measurable disease per WHO MDS with excess blasts criteria as defined either:
- 5%-9% blasts in the bone marrow or 2%-4% blasts in the peripheral blood or
- 10%-19% blasts in the bone marrow or 5%-19% blasts in the peripheral blood
- MDS that is relapsed or refractory and must not have other therapeutic options known to provide clinical benefit in MDS available.
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Treatment failure after prior hypomethylating agent (HMA) therapy for MDS, defined as one of the following:
- Progression (per 2006 International Working Group [IWG] criteria) at any time after initiation of HMA therapy.
- Lack of response (failure to achieve complete remission [CR], partial response [PR], or hematologic improvement [HI] per 2006 IWG criteria) after at least 6 cycles of azacitidine (or equivalent HMA) or 4 cycles of decitabine (or equivalent HMA).
- Relapse after achievement of CR, PR, or HI (per 2006 IWG criteria).
- Intolerance of HMA (Grade 3 or higher non-hematologic toxicity leading to treatment discontinuation).
- Participants with isolated 5q-/5q- syndrome must have progressed, failed, relapsed, or not tolerated lenalidomide in addition to HMA.
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- Must be off HMA therapy ≥ 2 weeks and must be off any other treatments for MDS for ≥ 4 weeks prior to first dose of SEA-CD70; growth factors and transfusions are allowed before and during the study as clinically indicated
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
Part B Inclusion Criteria
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Participants with cytologically/histologically confirmed MDS according to the WHO classification with the following:
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Measurable disease per WHO MDS with excess blasts (MDS-EB) criteria as defined either:
- 5%-9% blasts in the bone marrow or 2%-4% blasts in the peripheral blood, or
- 10%-19% blasts in the bone marrow or 5%-19% in the peripheral blood
- MDS that is relapsed or refractory and must not have other therapeutic options known to provide clinical benefit in MDS available.
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Treatment failure after prior HMA therapy for MDS defined as one of the following:
- Progression (per 2006 IWG criteria) at any time after initiation of HMA therapy.
- Lack of response (failure to achieve CR, PR, or HI per 2006 IWG criteria) after at least 6 cycles of azacitidine or 4 cycles of decitabine.
- Relapse after achievement of CR, PR, or HI (per 2006 IWG criteria).
- Intolerance of HMA (Grade 3 or higher non-hematologic toxicity leading to treatment discontinuation).
- Participants with isolated 5q-/5q- syndrome must have progressed, failed, relapsed, or not tolerated lenalidomide in addition to HMA.
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- Must be off HMA therapy ≥ 2 weeks and must be off any other systemic treatments for MDS for ≥ 4 weeks prior to first dose of SEA-CD70; growth factors (e.g., G-CSF, erythropoietin and thrombopoietin) and transfusions are allowed before and during the study as clinically indicated.
- ECOG Performance Status of 0-2
Part C Inclusion Criteria
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Participants with relapsed or refractory acute myeloid leukemia (AML) according to the WHO 2016 classification (except for acute promyelocytic leukemia [APL]):
- Who have received either 2 or 3 previous regimens to treat active disease. Post-remission treatments, intrathecal chemotherapy, and radiotherapy are not considered previous regimens.
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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 (defined as failure to achieve CR after 1-2 courses of induction therapy)
- First CR duration <6 months
- Adverse-risk per European Leukemia Net (ELN) genetic risk stratification
- Secondary AML (prior history of MDS or therapy-related)
- Age 18-75 years
- ECOG performance status of 0-2
Exclusion Criteria (All Parts)
- History of another malignancy within 3 years before the first dose of study drug or any evidence of residual disease from a previously diagnosed malignancy. Exceptions are malignancies with a negligible risk of metastasis or death.
- Previous exposure to CD70-targeted agents
- Prior allogeneic hematopoietic stem cell transplant, for any condition
- Central nervous system leukemia based on imaging or documented positive cytology in cerebral spinal fluid
- History of clinically significant sickle cell anemia, autoimmune hemolytic anemia, or idiopathic thrombocytopenic purpura

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): NCT04227847
Contact: Seagen Trial Information Support | 866-333-7436 | clinicaltrials@seagen.com |
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University of Alabama at Birmingham | Recruiting |
Birmingham, Alabama, United States, 35249 | |
Contact: Hilary Avery 205-934-7167 hilaryavery@uabmc.edu | |
Principal Investigator: Pankit Vachhani | |
United States, California | |
City of Hope National Medical Center | Recruiting |
Duarte, California, United States, 91010-3000 | |
Contact: Lucia Magos 626-256-4673 lmagos@coh.org | |
Principal Investigator: Ahmed M Aribi | |
United States, Colorado | |
Colorado Blood Cancer Institute | Recruiting |
Denver, Colorado, United States, 80218 | |
Contact: James Vick 720-754-4800 James.Vick@sarahcannon.com | |
Principal Investigator: Marcello Rotta | |
United States, Kentucky | |
Norton Cancer Institute | Recruiting |
Louisville, Kentucky, United States, 40207 | |
Contact: Joshua Roberts 502-899-2673 | |
Principal Investigator: Don A Stevens | |
United States, Massachusetts | |
Massachusetts General Hospital | Recruiting |
Boston, Massachusetts, United States, 02114 | |
Contact: Meghan Burke 617-726-1599 | |
Principal Investigator: Amir Fathi | |
Beth Israel Deaconess Medical Center | Recruiting |
Boston, Massachusetts, United States, 02215 | |
Contact: Kayla Loycano 617-667-9920 | |
Principal Investigator: Jessica Liegel | |
United States, Michigan | |
Karmanos Cancer Institute / Wayne State University | Recruiting |
Detroit, Michigan, United States, 48201 | |
Contact: Mary Domagalski 313-576-9767 domagalm@karmanos.org | |
Principal Investigator: Jay Yang | |
United States, Ohio | |
Case Western Reserve University / University Hospitals Cleveland Medical Center | Recruiting |
Cleveland, Ohio, United States, 44106 | |
Contact: Sarah Housour 216-286-7082 Sarah.Housour@uhhospitals.org | |
Principal Investigator: Benjamin K Tomlinson | |
Cleveland Clinic, The | Recruiting |
Cleveland, Ohio, United States, 44195 | |
Contact: Taussig Research group email 866-223-8100 TaussigResearch@ccf.org | |
Principal Investigator: Anjali Advani | |
James Cancer Hospital / Ohio State University | Recruiting |
Columbus, Ohio, United States, 43210 | |
Contact: Shayla Thompson 614-293-5655 | |
Principal Investigator: Alice Mims | |
Principal Investigator: Nicole Grieselhuber | |
United States, South Carolina | |
Medical University of South Carolina/Hollings Cancer Center | Recruiting |
Charleston, South Carolina, United States, 29425 | |
Contact: Shanta Salzer 843-792-1463 | |
Principal Investigator: Robert K Stuart | |
Principal Investigator: Praneeth Baratam | |
Saint Francis Hospital / Bon Secours - South Carolina | Recruiting |
Greenville, South Carolina, United States, 29607 | |
Contact: Sharon (Nikki) N Thompson 864-603-6238 | |
Principal Investigator: Howland Crosswell | |
Principal Investigator: Sharif S Khan | |
United States, Tennessee | |
Tennessee Oncology-Nashville/Sarah Cannon Research Institute | Completed |
Nashville, Tennessee, United States, 37203 | |
United States, Texas | |
Texas Oncology - Fort Worth | Recruiting |
Dallas, Texas, United States, 75246 | |
Contact: Joyce Ghormley 214-818-8961 | |
Principal Investigator: Edward J Pearson | |
MD Anderson Cancer Center / University of Texas | Recruiting |
Houston, Texas, United States, 77030-4095 | |
Contact: Heather Schneider 713-792-4478 hnschneider@mdanderson.org | |
Principal Investigator: Guillermo Garcia-Manero | |
Netherlands | |
Leids Universitair Medisch Centrum ( LUMC) | Recruiting |
Leiden, Other, Netherlands, 2333 ZA | |
Principal Investigator: Hendrik J Veelken |
Study Director: | Phoenix Ho, MD | Seagen Inc. |
Responsible Party: | Seagen Inc. |
ClinicalTrials.gov Identifier: | NCT04227847 |
Other Study ID Numbers: |
SGNS70-101 2019-001917-18 ( EudraCT Number ) |
First Posted: | January 14, 2020 Key Record Dates |
Last Update Posted: | May 10, 2022 |
Last Verified: | May 2022 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
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