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Cell Therapy

Gamma Delta T-cell Therapy for Leukemia

Q: Does my profile meet the criteria for participating in this experiment?

To gain acceptance into this clinical trial, applicants must have myelodysplastic syndromes and be between 18-65 years old. 38 individuals need to partake in the study for it to reach its completion goals.

Q: Has the FDA approved EAGD T-cell infusion as a therapeutic approach?

We have assessed the safety of EAGD T-cell infusion (Expansion) with a score of 1, as there is only limited evidence to support its efficacy and security.

Q: Does the study protocol allow for participants aged 75 and under?

This medical trial necessitates that potential participants are between 18 and 65 years of age. For those under 18, 500 studies exist as alternatives, while 1387 trials accommodate people over the stipulated age range.

Q: What outcomes is this experiment attempting to realize?

During the initial 100 days of this clinical trial, Phase I - Dose-limiting toxicity (DLT) will be monitored as a primary outcome. Secondary outcomes that are assessed during this time frame include Expansion phase - Relapse following haploidentical HCT and PTCy with EAGD T-cell infusion which is quantified by Number of subjects who have acute GVHD by day 100 post-HCT after infusion of EAGD T-cells, Rate of one year overall survival (OS) documented as Number of subjects living after one year following HCT, and Expansion phase - Non-relapse mortality following

Q: What is the cap on patient participation for this experiment?

Affirmative. The clinicaltrials.gov website outlines that this trial, initially posted on January 31st 2020, is actively seeking volunteers for enrolment. There are 38 spaces available at a single site.

Q: Is enrollment for this research study still available to the public?

Correct. According to clinicaltrials.gov, this study is actively looking for participants who can be found at a singular medical centre; the trial was first posted on January 31st 2020 and most recently updated on March 15th 2022 with an aim of accepting 38 patients in total.

Phase 1

Recruiting

Led By Joseph McGuirk, M.D.

Research Sponsored by University of Kansas Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients with neoplastic hematological disorders with indication of allogeneic transplant according to the National Comprehensive Cancer Network (NCCN) or other standard guidelines

Organ Function Criteria: Normal left ventricular ejection fraction (LVEF) (50% or above), FVC, FEV1 and DLCO (corrected) should be 50% or above of expected, serum creatinine level to be <2 mg/dl, serum bilirubin 1.5 upper limit of normal (ULN), Aspartate transaminase (AST)/alanine transaminase (ALT) 2.5 ULN, alkaline phosphatase 2.5 ULN, Karnofsky performance score (KPS) or Lansky score: ≥80, Hematopoietic cell transplant comorbidity index (HCT-CI) <3, informed consent obtained, Absence of uncontrolled infection with sepsis syndrome, NO hemodynamic instability, NO clinically significant organ toxicity, Neutrophil engraftment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to one year

Awards & highlights

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.

Who is the study for?

This trial is for adults aged 19-65 with certain blood cancers like leukemia or myelodysplastic syndrome, who are in remission but at high risk of relapse and need a bone marrow transplant. They must have good heart, lung, liver, and kidney function and not be pregnant or HIV positive. People with uncontrolled infections or severe organ toxicity can't join.Check my eligibility

What is being tested?

The study tests infusions of expanded/activated gamma delta T-cells after a partially mismatched bone marrow transplant to fight cancer cells while trying to prevent graft versus host disease in patients with specific leukemias and myelodysplastic syndrome.See study design

What are the potential side effects?

Potential side effects may include reactions related to the infusion such as fever or chills, increased risk of infection due to immune system changes, possible organ inflammation from immune responses, and complications related to graft versus host disease.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have a blood cancer that requires a stem cell transplant.

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My heart, lungs, and kidneys are functioning well, and I have no severe infections or organ toxicity.

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I am between 19 and 65 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to one year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to one year

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to one year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Expansion phase - Rate of acute GVHD

Phase I - Dose-limiting toxicity (DLT)

Phase I - Severe acute adverse events following infusion of EAGD T-cells

Secondary outcome measures

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

+4 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: EAGD T-cell infusion (Phase I)Experimental Treatment1 Intervention

Peripheral blood is collected by leukapheresis from the donor, expanded and activated on CliniMACS-Prodigy, further depleted of alpha beta T-cells using the CliniMACS Alpha Beta T-Cell Depletion System, which leaves a gamma delta T-cell rich product. This product is then infused into the recipient at either 1, 3, or 10 x 1,000,000 cells/kg concentrations depending upon the cohort.

Group II: EAGD T-cell infusion (Expansion)Experimental Treatment1 Intervention

Peripheral blood is collected by leukapheresis from the donor, expanded and activated on CliniMACS-Prodigy, further depleted of alpha beta T-cells using the CliniMACS Alpha Beta T-Cell Depletion System, which leaves a gamma delta T-cell rich product. This product is then infused into the recipient at the maximum tolerated dose as determined from Phase I.

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of Kansas Medical CenterLead Sponsor

463 Previous Clinical Trials

169,232 Total Patients Enrolled

3 Trials studying Leukemia

52 Patients Enrolled for Leukemia

In8bio Inc.Industry Sponsor

2 Previous Clinical Trials

141 Total Patients Enrolled

Joseph McGuirk, M.D.3.515 ReviewsPrincipal Investigator - University of Kansas Medical Center

University of Kansas Medical Center

5Patient Review

Dr. McGuirk is an excellent physician who exudes both confidence and compassion. We wholeheartedly trust his judgement and are grateful for the positive difference he has made in our lives!

Media Library

EAGD T-cell infusion (Cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03533816 — Phase 1

Leukemia Research Study Groups: EAGD T-cell infusion (Expansion), EAGD T-cell infusion (Phase I)

Leukemia Clinical Trial 2023: EAGD T-cell infusion Highlights & Side Effects. Trial Name: NCT03533816 — Phase 1

EAGD T-cell infusion (Cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03533816 — Phase 1

Frequently Asked Questions

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

Does my profile meet the criteria for participating in this experiment?

"To gain acceptance into this clinical trial, applicants must have myelodysplastic syndromes and be between 18-65 years old. 38 individuals need to partake in the study for it to reach its completion goals."

Answered by AI

Has the FDA approved EAGD T-cell infusion as a therapeutic approach?

"We have assessed the safety of EAGD T-cell infusion (Expansion) with a score of 1, as there is only limited evidence to support its efficacy and security."

Answered by AI

Does the study protocol allow for participants aged 75 and under?

"This medical trial necessitates that potential participants are between 18 and 65 years of age. For those under 18, 500 studies exist as alternatives, while 1387 trials accommodate people over the stipulated age range."

Answered by AI

What outcomes is this experiment attempting to realize?

"During the initial 100 days of this clinical trial, Phase I - Dose-limiting toxicity (DLT) will be monitored as a primary outcome. Secondary outcomes that are assessed during this time frame include Expansion phase - Relapse following haploidentical HCT and PTCy with EAGD T-cell infusion which is quantified by Number of subjects who have acute GVHD by day 100 post-HCT after infusion of EAGD T-cells, Rate of one year overall survival (OS) documented as Number of subjects living after one year following HCT, and Expansion phase - Non-relapse mortality following"

Answered by AI

What is the cap on patient participation for this experiment?

"Affirmative. The clinicaltrials.gov website outlines that this trial, initially posted on January 31st 2020, is actively seeking volunteers for enrolment. There are 38 spaces available at a single site."

Answered by AI

Is enrollment for this research study still available to the public?

"Correct. According to clinicaltrials.gov, this study is actively looking for participants who can be found at a singular medical centre; the trial was first posted on January 31st 2020 and most recently updated on March 15th 2022 with an aim of accepting 38 patients in total."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Expanded/Activated Gamma Delta T-cell Infusion Following Hematopoietic Stem Cell Transplantation and Post-transplant Cyclophosphamide

Joseph McGuirk 2020. "Expanded/Activated Gamma Delta T-cell Infusion Following Hematopoietic Stem Cell Transplantation and Post-transplant Cyclophosphamide". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03533816.

All > Mds > Myelodysplastic Syndrome