EAGD T-cell infusion (Expansion) for Myelodysplastic Syndromes

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Myelodysplastic Syndromes+7 More
EAGD T-cell infusion (Expansion) - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial uses gamma delta T-cells to kill cancer cells while minimizing GVHD in patients who have had a partially mismatched bone marrow transplant.

Eligible Conditions
  • Myelodysplastic Syndromes
  • leukemia
  • Leukemia, Myelocytic, Acute
  • Acute Lymphoblastic Leukemia (ALL)

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Myelodysplastic Syndromes

Study Objectives

3 Primary · 7 Secondary · Reporting Duration: Baseline to one year

Baseline to 100 days
Expansion phase - Non-relapse mortality following haploidentical HCT and PTCy with EAGD T-cell infusion
Expansion phase - Overall survival following haploidentical HCT and PTCy with EAGD T-cell infusion
Expansion phase - Relapse following haploidentical HCT and PTCy with EAGD T-cell infusion
Baseline to Day 100
Expansion phase - Rate of acute GVHD
Phase I - Severe acute adverse events following infusion of EAGD T-cells
Baseline to Day 30
Phase I - Dose-limiting toxicity (DLT)
Baseline to one year
Proportion of subjects with chronic GVHD at one year
Rate of one-year non-relapse mortality (NRM)
Rate of one-year overall survival (OS)
Rate of one-year relapse-free survival (RFS)

Trial Safety

Safety Progress

1 of 3

Other trials for Myelodysplastic Syndromes

Trial Design

2 Treatment Groups

EAGD T-cell infusion (Phase I)
1 of 2
EAGD T-cell infusion (Expansion)
1 of 2
Experimental Treatment

38 Total Participants · 2 Treatment Groups

Primary Treatment: EAGD T-cell infusion (Expansion) · No Placebo Group · Phase 1

EAGD T-cell infusion (Phase I)
Drug
Experimental Group · 1 Intervention: EAGD T-cell infusion (Phase I) · Intervention Types: Drug
EAGD T-cell infusion (Expansion)
Drug
Experimental Group · 1 Intervention: EAGD T-cell infusion (Expansion) · Intervention Types: Drug

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline to one year

Who is running the clinical trial?

In8bio Inc.Industry Sponsor
1 Previous Clinical Trials
12 Total Patients Enrolled
University of Kansas Medical CenterLead Sponsor
397 Previous Clinical Trials
158,156 Total Patients Enrolled
1 Trials studying Myelodysplastic Syndromes
15 Patients Enrolled for Myelodysplastic Syndromes
Joseph McGuirk, M.D.3.515 ReviewsPrincipal Investigator - University of Kansas Medical Center
University of Kansas Medical Center
1Patient Review
He came across as arrogant and pompous.

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have chronic myeloid leukemia [CML] in any chronic phase.
A diagnosis of acute lymphoblastic leukemia in morphologic complete remission with high-risk features or relapsed disease.
The following criteria are used to enroll patients in the study before transplant.
You have a physical organ function that is not affected by the study.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 8th, 2021

Last Reviewed: October 20th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.