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Monoclonal Antibodies

SEA-CD70 for Myelodysplastic Syndrome and Acute Myeloid Leukemia

Phase 1
Recruiting
Research Sponsored by Seagen Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Intolerance of HMA (Grade 3 or higher non-hematologic toxicity leading to treatment discontinuation).
MDS that is relapsed or refractory and must not have other therapeutic options known to provide clinical benefit in MDS available.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 4 years
Awards & highlights

Study Summary

This trial will examine the safety and efficacy of SEA-CD70 in patients with myelodysplastic syndrome and acute myeloid leukemia.

Who is the study for?
This trial is for patients with myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML). Participants must have relapsed after partial remission or shown no response to previous treatments like azacitidine. They should be in good physical condition, with an ECOG performance status of 0-1, and not have other treatment options available.Check my eligibility
What is being tested?
The study tests SEA-CD70 alone and combined with azacitidine to determine the safe dosage levels and effectiveness against MDS and AML. It's divided into six parts, each aiming to establish safety profiles and dosages for different patient groups within these conditions.See study design
What are the potential side effects?
Potential side effects are not specified but generally include any unintended effects besides treating cancer. These could range from mild reactions at the injection site to more serious systemic responses.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I had a severe reaction to HMA treatment and had to stop it.
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My MDS has returned or is not responding to treatment, and I have no other known beneficial treatment options.
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My treatment with azacitidine or decitabine for at least 6 or 4 cycles, respectively, did not work.
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My condition worsened after starting HMA therapy.
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I am fully active or can carry out light work.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 4 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 4 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of participants with a dose-limiting toxicity (DLT) at each dose level (Parts A and D only)
Number of participants with adverse events (AEs)
Number of participants with laboratory abnormalities
Secondary outcome measures
AUC - Area under the plasma concentration-time curve
Blast clearance rate for participants with MDS
Cmax - Maximum observed plasma concentration
+16 more

Trial Design

6Treatment groups
Experimental Treatment
Group I: Part FExperimental Treatment2 Interventions
SEA-CD70 + azacitidine expansion cohort in relapsed/refractory MDS or AML arising from MDS
Group II: Part EExperimental Treatment2 Interventions
SEA-CD70 + azacitidine expansion cohort in previously untreated higher-risk MDS
Group III: Part DExperimental Treatment2 Interventions
SEA-CD70 + azacitidine dose-finding/dose optimization cohorts in relapsed/refractory MDS or AML arising from MDS, and previously untreated higher-risk MDS
Group IV: Part CExperimental Treatment1 Intervention
SEA-CD70 expansion cohort in relapsed/refractory AML
Group V: Part BExperimental Treatment1 Intervention
SEA-CD70 expansion cohort in relapsed/refractory (HMA-failure) MDS
Group VI: Part AExperimental Treatment1 Intervention
SEA-CD70 dose escalation cohort in relapsed/refractory (HMA-failure) MDS
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
azacitidine
2005
Completed Phase 3
~1740

Find a Location

Who is running the clinical trial?

Seagen Inc.Lead Sponsor
208 Previous Clinical Trials
73,858 Total Patients Enrolled
Phoenix Ho, MDStudy DirectorSeagen Inc.
6 Previous Clinical Trials
959 Total Patients Enrolled
Juan Pinelli, PA-C, MMScStudy DirectorSeagen Inc.
2 Previous Clinical Trials
125 Total Patients Enrolled

Media Library

SEA-CD70 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04227847 — Phase 1
Acute Myeloid Leukemia Research Study Groups: Part A, Part B, Part C, Part D, Part E, Part F
Acute Myeloid Leukemia Clinical Trial 2023: SEA-CD70 Highlights & Side Effects. Trial Name: NCT04227847 — Phase 1
SEA-CD70 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04227847 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are volunteers being currently recruited for this research?

"Affirmative, the available information on clinicaltrials.gov suggests that this trial is currently enlisting participants. It was initially distributed on August 7th 2020 and revised for accuracy most recently October 28th 2022. The research requires 140 individuals to be recruited from 17 different locations."

Answered by AI

What is the ultimate purpose of this research endeavor?

"This trial's primary outcome metric, measured over a 4-week period of DLT evaluation, is the number of participants with dose-limiting toxicities (DLTs). Secondary outcomes include overall response rate (ORR), terminal elimination half-life (T1/2), and TI maintenance rate."

Answered by AI

What is the current size of this research cohort?

"To initiate this study, Seagen Inc. requires 140 individuals that meet the inclusion criteria. The trial will be conducted in multiple locations including the Swedish Cancer Institute of Seattle and University of Kansas Cancer Center in Fairway."

Answered by AI

How many locations are currently conducting this experiment?

"Numerous medical centres are currently enrolling participants in this trial, such as the Swedish Cancer Institute in Seattle, University of Kansas Cancer Center in Fairway and Texas Oncology - Fort Worth located near Dallas. In addition to these 3 sites, 14 additional locations are participating in recruitment for this study."

Answered by AI

Has SEA-CD70 been sanctioned by the FDA?

"Our internal hazard rating for SEA-CD70 is 1 due to its status as a Phase 1 trial, indicating limited data on both safety and efficacy."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Safety Study of SEA-CD70 in Patients With Myeloid Malignancies
2020. "A Safety Study of SEA-CD70 in Patients With Myeloid Malignancies". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04227847.
~19 spots leftby Dec 2024
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