Expanded/Activated Gamma Delta T-cell Infusion Following Hematopoietic Stem Cell Transplantation and Post-transplant Cyclophosphamide
Phase I Study of Ex Vivo Expanded/Activated Gamma Delta T-cell Infusion Following Haploidentical Hematopoietic Stem Cell Transplantation and Post-transplant Cyclophosphamide
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years to 65 Years
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests gamma delta T-cells, immune cells that can kill cancer cells, after a partly matched donor bone marrow transplant. It is for adults with certain leukemias or myelodysplastic syndrome, a bone marrow disease. The goal is to fight cancer while limiting graft-versus-host disease (GVHD), when donor cells attack the patient's body.
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).
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Be 19–65 years old and need a donor stem cell transplant under standard care guidelines.
- Have one of these diseases: AML with medium- or high-risk features or that has returned, with no visible signs of leukemia under a microscope; CML in a chronic phase; medium- or high-risk MDS or MDS that resists treatment, with less than 10% immature cells in the marrow; or high-risk ALL or ALL that has returned, with no visible signs under a microscope.
- Test negative for antibodies against the donor within 28 days before starting transplant preparation.
- Have heart, lung, kidney, and liver tests within 35 days before joining. Heart pumping strength must be at least 50%, and lung test results at least 50% of expected. Kidney and liver results must meet study rules.
- Score at least 80 on a scale of ability to do daily tasks. Have a transplant health-risk score below 3, unless the study leader allows an exception.
- Understand that the study is experimental and sign a written consent form.
- Within 48 hours before the T-cell infusion, have no uncontrolled infection with sepsis, unstable blood circulation, excess fluid, or major heart, kidney, liver, or lung problems.
- Before the infusion, have no acute GVHD. The transplanted cells must have started making neutrophils, white blood cells that fight infection.
Who can't join
- Not able to follow study requirements.
- No suitable caregiver.
- Uncontrolled medical or mental health problems that the doctor believes would prevent study participation.
- Cancer in the brain or spinal cord.
- Body mass index (BMI), a measure of weight for height, above 35. Borderline cases may be considered individually.
- Known allergy to DMSO.
- Positive test for HIV-1 or HIV-2.
- Pregnant or breastfeeding.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
Inclusion Criteria: 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. * 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. Exclusion Criteria: * 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.
Study sites (2)
KS
- University of Kansas Cancer Center · Westwood, KS 66205Clinical Trials Nurse Navigator · Study contact · 913-945-7552 · ctnursenav@kumc.eduJoseph McGuirk, M.D. · Study contact · 913-588-6030 · jmcguirk@kumc.eduMore trials in Westwood
OH
- Ohio State University Medical Center · Columbus, OH 43210-1238More trials in Columbus