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

  • STATUS
    Recruiting
  • End date
    Oct 31, 2024
  • participants needed
    60
  • sponsor
    Seagen Inc.
Updated on 27 May 2022
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 IdentifierNCT04227847
SponsorSeagen Inc.
Last Modified on27 May 2022

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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