Acute Myeloid LeukemiaPhase 1NCT03533816
Expanded/Activated Gamma Delta T-cell Infusion Following Hematopoietic Stem Cell Transplantation and Post-transplant Cyclophosphamide
A Phase 1 study testing EAGD T-cell infusion (Phase I) and EAGD T-cell infusion (Expansion) in people with Acute Myeloid Leukemia and Chronic Myeloid Leukemia, run by University of Kansas Medical Center at 2 sites in United States.
Trial summary
Gamma delta T-cells are part of the innate immune system with the ability to recognize malignant cells and kill them. This study uses gamma delta T-cells to maximize the anti-tumor response and minimize graft versus host disease (GVHD) in leukemic and myelodysplastic patients who have had a partially mismatched bone… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Acute Myeloid Leukemia, Chronic Myeloid Leukemia, Acute Lymphoblastic Leukemia
- What is being tested?
- EAGD T-cell infusion (Phase I) and EAGD T-cell infusion (Expansion)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 2 sitesUnited States
- Study dates
- 31 Jan 2020to Jan 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The following criteria are used to enroll patients in the study before transplant.
- Patients with neoplastic hematological disorders with indication of allogeneic transplant according to the National Comprehensive Cancer Network (NCCN) or other standard guidelines as follows:
- Acute myeloid leukemia [AML] in morphologic complete remission with intermediate/high-risk features (per NCCN criteria) or relapsed disease
- Chronic myeloid leukemia [CML] in any chronic phase.
- Myelodysplastic syndrome [MDS] with intermediate/high risk features or refractory disease (with bone marrow blast count <10%).
- Acute lymphoblastic leukemia [ALL] in morphologic complete remission with high-risk features or relapsed disease.
Show all 26Show fewer
- Negative test for donor-specific antibody within 28 days of starting conditioning regimen.
- Age Criteria: 19-65 years.
- Organ Function Criteria: The following organ function testing should be done within 35 days before study registration.
- Cardiac: Normal left ventricular ejection fraction (LVEF) (50% or above) as measured by MUGA or Echocardiogram.
- Pulmonary: FVC, FEV1 and DLCO (corrected) should be 50% or above of expected.
- Renal: serum creatinine level to be <2 mg/dl AND estimated (Cockcroft-Gault formula) or measured (takes priority if done) creatinine clearance (CrCl) must be equal or greater than 70 mL/min/1.73 m2.
- Hepatic: serum bilirubin 1.5 upper limit of normal (ULN), Aspartate transaminase (AST)/alanine transaminase (ALT) 2.5 ULN, and alkaline phosphatase 2.5 ULN.
- Performance status: Karnofsky performance score (KPS) or Lansky score: ≥80.
- Hematopoietic cell transplant comorbidity index (HCT-CI) <3. Exception may be made on individual cases after discussion with the primary investigator.
- Consent: All patients must be informed of the investigational nature of this study and given written informed consent in accordance with institutional and federal guidelines.
- The following criteria are required within 48 hours prior to infusion of the EAGD T cell product.
- Absence of uncontrolled infection with sepsis syndrome (e.g persistent positive blood culture).
- NO hemodynamic instability (due to sepsis or organ dysfunction) or circulatory volume overload.
- NO clinically significant organ toxicity that are defined as follows:
- Heart failure with subnormal LVEF or clinical fluid overload.
- Elevated serum creatinine or subnormal creatinine clearance (either estimated or measured).
- Elevated total bilirubin ≥1.5 upper normal level (unless indirect hyperbilirubinemia attributed to non-hepatic pathology), or elevated liver enzymes (ALT, AST, ALP) >5 x ULN.
- Hypoxemia requiring oxygen therapy
- NO acute graft versus host disease (any grade).
- Neutrophil engraftment.
Who cannot join
- Non-compliant patients.
- No appropriate caregivers identified.
- Uncontrolled medical or psychiatric disorders which may preclude patients to undergo clinical studies (Discretion of the attending physician).
- Active central nervous system (CNS) neoplastic involvement.
- Morbid obesity with body mass index >35 (borderline cases may be considered on case-by-case basis after discussion with the primary investigator).
- Patients with known allergy to DMSO.
- HIV1 (Human Immunodeficiency Virus-1) or HIV2 positive.
- Pregnant or breastfeeding women.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Ohio State University Medical Center
Columbus, Ohio, 43210-1238
- Recruiting
University of Kansas Cancer Center
Westwood, Kansas, 66205
Clinical Trials Nurse Navigator, 913-945-7552, ctnursenav@kumc.edu
Joseph McGuirk, M.D., 913-588-6030, jmcguirk@kumc.edu
About this study
Official title: Phase I Study of Ex Vivo Expanded/Activated Gamma Delta T-cell Infusion Following Haploidentical Hematopoietic Stem Cell Transplantation and Post-transplant Cyclophosphamide
Gamma delta T-cells are part of the innate immune system with the ability to recognize malignant cells and kill them. This study uses gamma delta T-cells to maximize the anti-tumor response and minimize graft versus host disease (GVHD) in leukemic and myelodysplastic patients who have had a partially mismatched bone marrow transplant (haploidentical).
Read the detailed description
Many patients with hematological malignancies require a bone marrow transplant for curative treatment. A matched sibling donor is optimal but may not be available. Therefore, a partially matched family member (haploidentical) may be a viable alternative. The incidence of graft vs. host disease, however, can become more of a significant, even fatal, factor with partial matches.
T-cells have been shown to be the key player in the post-transplant immune phenomena. The majority of T-cells are composed of alpha beta T-cells with a small minority of gamma delta T-cells, which are known to have the unique ability to kill malignant cells without antigen recognition.
This study proposes to extract, concentrate, and activate gamma delta T-cells from the peripheral blood to provide innate anti-tumor effect with minimal risk of GVHD. Safety and impact and/or the rate of GVHD will be evaluated.
- Conditions
- Acute Myeloid Leukemia, Chronic Myeloid Leukemia, Acute Lymphoblastic Leukemia, Myelodysplastic Syndromes
- Being tested
- EAGD T-cell infusion (Phase I), EAGD T-cell infusion (Expansion)
- Keywords
- Gamma delta T-cells, Hematopoietic Stem Cell Transplantation (HCT), Post-transplant Cyclophosphamide (PTCy), Expanded/Activated gamma delta (EAGD), Graft versus host disease (GVHD), haploidentical
- Medical subject headings
- Leukemia, Myeloid, Acute, Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Myelodysplastic Syndromes, Graft vs Host Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EAGD T-cell infusion (Phase I)Drug
Also called CliniMACS-Prodigy, CliniMACS Alpha Beta T-Cell Depletion System
The Alpha Beta (α/β) T-Cell Depletion System utilizes the CliniMACS instrument to yield a gamma delta (γδ) enriched cell therapy product.
EAGD T-cell infusion (Expansion)Drug
Also called CliniMACS-Prodigy, CliniMACS Alpha Beta T-Cell Depletion System
The Alpha Beta (α/β) T-Cell Depletion System utilizes the CliniMACS instrument to yield a gamma delta (γδ) enriched cell therapy product.
| Study group | Role | What they receive |
|---|---|---|
| EAGD T-cell infusion (Phase I) | Experimental | 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. Receives: Drug: EAGD T-cell infusion (Phase I) |
| EAGD T-cell infusion (Expansion) | Experimental | 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. Receives: Drug: EAGD T-cell infusion (Expansion) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase I - Dose-limiting toxicity (DLT)
The dose escalation strategy will follow the Food and Drug Administration Guideline for design of early phase clinical trials of cellular therapy products.
Measured: Baseline to Day 30
Phase I - Severe acute adverse events following infusion of EAGD T-cells
Safety of the infusion will be based on the risk of treatment-related severe adverse events as identified in the National Cancer Common Terminology Criteria for Adverse Events (CTCAE) version 4.
Measured: Baseline to Day 100
Expansion phase - Rate of acute GVHD
Monitoring for GVHD is assessed with Grade II-IV adverse events as identified by the National Cancer Common Terminology Criteria for Adverse Events (CTCAE) version 4.
Measured: Baseline to Day 100
Secondary outcomes (7)
Expansion phase - Relapse following haploidentical HCT and PTCy with EAGD T-cell infusion
Number of subjects who have acute GVHD by day 100 post-HCT after infusion of EAGD T-cells
Measured: Baseline to 100 days
Expansion phase - Non-relapse mortality following haploidentical HCT and PTCy with EAGD T-cell infusion
Number of subjects who have no relapse by day 100 post-HCT after infusion
Measured: Baseline to 100 days
Expansion phase - Overall survival following haploidentical HCT and PTCy with EAGD T-cell infusion
Number of subjects who are living by day 100 post-HCT after infusion
Measured: Baseline to 100 days
Rate of one-year relapse-free survival (RFS)
Number of subjects living without relapse of disease after one year following HCT
Measured: Baseline to one year
Rate of one-year non-relapse mortality (NRM)
Number of subjects no longer living but not from disease relapse after one year following HCT
Measured: Baseline to one year
Rate of one-year overall survival (OS)
Number of subjects living after one year following HCT
Measured: Baseline to one year
Proportion of subjects with chronic GVHD at one year
Number of subjects with chronic GVHD after one year following HCT
Measured: Baseline to one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2018
- Study start31 Jan 2020
- Primary completionJan 2027 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myeloid LeukemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- This dose escalation study will be conducted in two phases. The first phase will have three cohorts with three recipient/donor pairs at different dose levels for each cohort. The second phase is an expansion cohort at the maximum tolerated dose determined in the first phase.
- Masking
- None (open label)
- Enrolment
- 38 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- In8bio Inc.
- Responsible party
- Principal investigator, Joseph McGuirk, University of Kansas Medical Center
- Investigators
- Joseph McGuirk, M.D., Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03533816
- Sponsor's protocol ID
- IIT-2018-Gamma-DeltaTcell
- Status last verified
- Mar 2026
- First submitted
- 10 May 2018
- Last updated
- 25 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study of Ex Vivo Expanded/Activated Gamma Delta T-cell Infusion Following Haploidentical Hematopoietic Stem Cell Transplantation and Post-transplant Cyclophosphamide
- ClinicalTrials.gov ID
- NCT03533816
- Acronym / sponsor ID
- IIT-2018-Gamma-DeltaTcell
- Conditions
- Acute Myeloid Leukemia, Chronic Myeloid Leukemia, Acute Lymphoblastic Leukemia, Myelodysplastic Syndromes
- Keywords
- Gamma delta T-cells, Hematopoietic Stem Cell Transplantation (HCT), Post-transplant Cyclophosphamide (PTCy), Expanded/Activated gamma delta (EAGD), Graft versus host disease (GVHD), haploidentical
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Collaborators
- In8bio Inc.
- Study start
- 31 Jan 2020 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 23 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Gamma delta T-cells are part of the innate immune system with the ability to recognize malignant cells and kill them. This study uses gamma delta T-cells to maximize the anti-tumor response and minimize graft versus host disease (GVHD) in leukemic and myelodysplastic patients who have had a partially mismatched bone marrow transplant (haploidentical).
Detailed description
Many patients with hematological malignancies require a bone marrow transplant for curative treatment. A matched sibling donor is optimal but may not be available. Therefore, a partially matched family member (haploidentical) may be a viable alternative. The incidence of graft vs. host disease, however, can become more of a significant, even fatal, factor with partial matches.
T-cells have been shown to be the key player in the post-transplant immune phenomena. The majority of T-cells are composed of alpha beta T-cells with a small minority of gamma delta T-cells, which are known to have the unique ability to kill malignant cells without antigen recognition.
This study proposes to extract, concentrate, and activate gamma delta T-cells from the peripheral blood to provide innate anti-tumor effect with minimal risk of GVHD. Safety and impact and/or the rate of GVHD will be evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This dose escalation study will be conducted in two phases. The first phase will have three cohorts with three recipient/donor pairs at different dose levels for each cohort. The second phase is an expansion cohort at the maximum tolerated dose determined in the first phase.
| Arm | Type | Receives |
|---|---|---|
| EAGD T-cell infusion (Phase I) | Experimental | Drug: EAGD T-cell infusion (Phase I)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. |
| EAGD T-cell infusion (Expansion) | Experimental | Drug: EAGD T-cell infusion (Expansion)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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (26 listed)
- The following criteria are used to enroll patients in the study before transplant.
- Patients with neoplastic hematological disorders with indication of allogeneic transplant according to the National Comprehensive Cancer Network (NCCN) or other standard guidelines as follows:
- Negative test for donor-specific antibody within 28 days of starting conditioning regimen.
- Age Criteria: 19-65 years.
- Organ Function Criteria: The following organ function testing should be done within 35 days before study registration.
Key exclusion criteria (8 listed)
- Non-compliant patients.
- No appropriate caregivers identified.
- Uncontrolled medical or psychiatric disorders which may preclude patients to undergo clinical studies (Discretion of the attending physician).
- Active central nervous system (CNS) neoplastic involvement.
- Morbid obesity with body mass index >35 (borderline cases may be considered on case-by-case basis after discussion with the primary investigator).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EAGD T-cell infusion (Phase I)Also: CliniMACS-Prodigy, CliniMACS Alpha Beta T-Cell Depletion SystemThe Alpha Beta (α/β) T-Cell Depletion System utilizes the CliniMACS instrument to yield a gamma delta (γδ) enriched cell therapy product. | Drug | EAGD T-cell infusion (Phase I) |
| EAGD T-cell infusion (Expansion)Also: CliniMACS-Prodigy, CliniMACS Alpha Beta T-Cell Depletion SystemThe Alpha Beta (α/β) T-Cell Depletion System utilizes the CliniMACS instrument to yield a gamma delta (γδ) enriched cell therapy product. | Drug | EAGD T-cell infusion (Expansion) |
Primary outcome
Phase I - Dose-limiting toxicity (DLT)
Time frame: Baseline to Day 30
The dose escalation strategy will follow the Food and Drug Administration Guideline for design of early phase clinical trials of cellular therapy products.
Phase I - Severe acute adverse events following infusion of EAGD T-cells
Time frame: Baseline to Day 100
Safety of the infusion will be based on the risk of treatment-related severe adverse events as identified in the National Cancer Common Terminology Criteria for Adverse Events (CTCAE) version 4.
Expansion phase - Rate of acute GVHD
Time frame: Baseline to Day 100
Monitoring for GVHD is assessed with Grade II-IV adverse events as identified by the National Cancer Common Terminology Criteria for Adverse Events (CTCAE) version 4.
7 secondary outcomes
Expansion phase - Relapse following haploidentical HCT and PTCy with EAGD T-cell infusion
Time frame: Baseline to 100 days
Expansion phase - Non-relapse mortality following haploidentical HCT and PTCy with EAGD T-cell infusion
Time frame: Baseline to 100 days
Expansion phase - Overall survival following haploidentical HCT and PTCy with EAGD T-cell infusion
Time frame: Baseline to 100 days
Rate of one-year relapse-free survival (RFS)
Time frame: Baseline to one year
Rate of one-year non-relapse mortality (NRM)
Time frame: Baseline to one year
Rate of one-year overall survival (OS)
Time frame: Baseline to one year
Proportion of subjects with chronic GVHD at one year
Time frame: Baseline to one year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Joseph McGuirk, M.D. principal investigator
University of Kansas Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing EAGD T-cell infusion (Phase I) and EAGD T-cell infusion (Expansion) in people with Acute Myeloid Leukemia and Chronic Myeloid Leukemia, run by University of Kansas Medical Center at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 26 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Trial Nurse Navigator (913-945-7552, ctnursenav@kumc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase I - Dose-limiting toxicity (DLT) (time frame: Baseline to Day 30). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2026.