Gamma Delta T-cell Therapy for Leukemia
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new therapy using special immune cells called gamma delta T-cells to combat leukemia and myelodysplastic syndrome. These cells aim to attack cancer while reducing graft versus host disease, a condition that can occur after a bone marrow transplant. The treatment, known as EAGD T-cell infusion, involves infusing these activated cells into patients who have already undergone a partially matched bone marrow transplant. The trial seeks participants who have certain types of leukemia or myelodysplastic syndrome and have had a transplant without serious infections or organ problems. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this innovative therapy.
Do I need to stop my current medications for the trial?
The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.
Is there any evidence suggesting that this treatment is likely to be safe for humans?
Research shows that gamma delta T-cell therapy holds promise for treating leukemia. In earlier studies, researchers successfully grew and activated these cells, with over 90% remaining healthy. Importantly, the treatment showed less than 0.06% contamination with other T-cells, indicating high purity.
These gamma delta T-cells target cancer cells while reducing the risk of graft versus host disease (GVHD), a complication where donor cells attack the patient's body. So far, the treatment appears well-tolerated, a positive sign for safety.
As this trial is in the early stages, it primarily focuses on assessing the treatment's safety. Researchers will closely monitor any side effects. Based on current observations, the treatment seems safe for participants.12345Why do researchers think this study treatment might be promising?
Unlike the standard leukemia treatments, which often include chemotherapy and stem cell transplants, EAGD T-cell infusion harnesses the power of gamma delta T-cells, a unique type of immune cell. These cells are expanded and activated outside the body and specifically enriched to target leukemia cells more effectively. Researchers are excited because this method could offer a more targeted attack on cancer cells with potentially fewer side effects compared to traditional therapies. This innovative approach might improve patient outcomes by utilizing the body's own immune system in a novel way.
What evidence suggests that EAGD T-cell infusion might be an effective treatment for leukemia?
Research has shown that gamma delta T-cells could be helpful in treating leukemia. These immune cells can locate and attack cancer cells. Some studies found that patients treated with gamma delta T-cells lived longer and had a lower chance of leukemia recurrence. In this trial, participants will receive the EAGD T-cell infusion, which targets cancer cells while reducing side effects like graft versus host disease (GVHD), a condition where donor cells attack the patient's body. Although this treatment remains in the early stages, it has demonstrated a high success rate in keeping the cells active and ready to fight cancer.23456
Who Is on the Research Team?
Joseph McGuirk, M.D.
Principal Investigator
University of Kansas Medical Center
Are You a Good Fit for This Trial?
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.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Hematopoietic Stem Cell Transplantation
Participants undergo haploidentical hematopoietic stem cell transplantation
Post-transplant Cyclophosphamide
Participants receive post-transplant cyclophosphamide to minimize graft versus host disease
EAGD T-cell Infusion (Phase I)
Infusion of expanded/activated gamma delta T-cells at varying concentrations to determine maximum tolerated dose
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessment of GVHD and overall survival
What Are the Treatments Tested in This Trial?
Interventions
- EAGD T-cell infusion
Trial Overview
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.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
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.
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Kansas Medical Center
Lead Sponsor
In8bio Inc.
Industry Sponsor
Citations
Gamma delta T cells in acute myeloid leukemia
However, cures are elusive, and the 3-year overall survival (OS) remains poor, at 25%, with dismal outcomes after the failure of frontline ...
NCT03533816 | Expanded/Activated Gamma Delta T-cell ...
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 ...
3.
ashpublications.org
ashpublications.org/blood/article/144/Supplement%201/4826/533293/Phase-I-Trial-of-Ex-Vivo-Expanded-Donor-GammaPhase I Trial of Ex Vivo Expanded Donor Gamma Delta T Cell ...
GDT cell expansion was successful in all cases with all products achieving >90% GDT cell viability and <0.06% alpha beta T cell contamination.
Gamma delta T cells and their immunotherapeutic potential in ...
This review delves into conventional and novel approaches to γδ T cell therapy, including engineered therapies, focusing on their therapeutic efficacy and ...
Gamma delta T cells in acute myeloid leukemia
Insights from murine models and clinical data in humans show improved overall survival, leukemia- free survival, reduced risk of relapse, enhanced graft- versus ...
Harnessing the immunotherapeutic potentials of gamma ...
This comprehensive review provides an overview of the rationale for γδ T‐cell therapy, ongoing clinical trials, as well as the challenges and ...
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