A Safety Study of SEA-CD70 in Patients With Myeloid Malignancies

STATUS

Recruiting
End date

Oct 31, 2024
participants needed

60
sponsor

Seagen Inc.

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Updated on 27 May 2022

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cancer

remission

hydroxyurea

filgrastim

granulocyte colony stimulating factor

decitabine

residual tumor

azacitidine

refractory acute myeloid leukemia (aml)

secondary acute myeloid leukemia

acute promyelocytic leukemia

blast cells

lenalidomide

colony stimulating factor

Summary

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.

Description

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.

Details

Condition	Myelodyspastic Syndrome, Acute Myeloid Leukemia
Treatment	SEA-CD70
Clinical Study Identifier	NCT04227847
Sponsor	Seagen Inc.
Last Modified on	27 May 2022

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Eligibility		Yes	No	Not Sure
Inclusion Criteria
	Participants with cytologically/histologically confirmed myelodysplastic syndrome (MDS) according to the 2016 World Health Organization (WHO) classification with the
	Measurable disease per WHO MDS with excess blasts criteria as defined either
	%-9% blasts in the bone marrow or 2%-4% blasts in the peripheral blood or
	Treatment failure after prior hypomethylating agent (HMA) therapy for MDS, defined as one of the following
	%-19% blasts in the bone marrow or 5%-19% blasts in the peripheral blood
	Progression (per 2006 International Working Group [IWG] criteria) at any time after initiation of HMA therapy
	MDS that is relapsed or refractory and must not have other therapeutic options
	Relapse after achievement of CR, PR, or HI (per 2006 IWG criteria)
	known to provide clinical benefit in MDS available
	Intolerance of HMA (Grade 3 or higher non-hematologic toxicity leading to treatment discontinuation)
	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)
	Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
	Participants with isolated 5q-/5q- syndrome must have progressed, failed, relapsed, or not tolerated lenalidomide in addition to HMA
	Part B Inclusion Criteria
	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
	Treatment failure after prior HMA therapy for MDS defined as one of the
	Participants with cytologically/histologically confirmed MDS according to the WHO classification with the following
	Measurable disease per WHO MDS with excess blasts (MDS-EB) criteria as defined
	following
	either
	Progression (per 2006 IWG criteria) at any time after initiation of HMA therapy
	%-9% blasts in the bone marrow or 2%-4% blasts in the peripheral blood, or
	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
	%-19% blasts in the bone marrow or 5%-19% in the peripheral blood
	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)
	following
	MDS that is relapsed or refractory and must not have other therapeutic options
	ECOG Performance Status of 0-2
	known to provide clinical benefit in MDS available
	Part C Inclusion Criteria
	Participants with isolated 5q-/5q- syndrome must have progressed, failed, relapsed, or not tolerated lenalidomide in addition to HMA
	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
	Who have received 1 previous regimen to treat active disease and have at least one of the following
	Primary resistant AML (defined as failure to achieve CR after 1-2 courses of induction therapy)
	First CR duration <6 months
	Participants with relapsed or refractory acute myeloid leukemia (AML) according to the WHO 2016 classification (except for acute promyelocytic leukemia [APL])
	Must be off HMA therapy ≥ 2 weeks and must be off any other systemic treatments for
	Adverse-risk per European Leukemia Net (ELN) genetic risk stratification
	Secondary AML (prior history of MDS or therapy-related)
	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
	Age 18-75 years
	ECOG performance status of 0-2
	and during the study as clinically indicated
	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
	Age > 60 and ≤75 years
	History of clinically significant sickle cell anemia, autoimmune hemolytic anemia, or idiopathic thrombocytopenic purpura

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A Safety Study of SEA-CD70 in Patients With Myeloid Malignancies