Actively Recruiting
IS-free Treg HaploHCT
Led by Dana-Farber Cancer Institute · Updated on 2025-10-20
30
Participants Needed
1
Research Sites
450 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research study is evaluating the safety and efficacy of the IS-free Treg-cell graft-engineered haplo transplant method in people with relapsed/refractory and Ultra-high risk acute myeloid leukemia (AML) and/or myelodysplastic syndromes (MDS) receiving a haploidentical donor allogeneic hematopoietic stem cell transplant (HSCT). The names of the study interventions involved in this study are: * Radiation-Total Myeloid and Lymphoid Irradiation (TMLI) * Chemotherapy (Fludarabine, Thiotepa, Cyclophosphamide plus Mesna) * Infusion of haplo Treg-enriched donor cells (experimental therapy) * Infusion of unmodified haplo donor T cells (includes cancer-fighting T effector cells) * Infusion of haplo donor CD34+ Peripheral Blood Stem Cells
CONDITIONS
Official Title
IS-free Treg HaploHCT
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed relapsed or refractory AML with \u22655% blasts in bone marrow or myelodysplastic syndrome EB-2 with 10% or more blasts in bone marrow
- Ultra high-risk AML or MDS with mutated TP53 as defined by 2022 International Consensus Classification
- Ultra high-risk AML or MDS with multi-hit or complex karyotype mutated TP53 with response and low blast counts
- Available haploidentical HLA-matched related donor aged 18 to 65 years
- Age 18 to 65 years for cohorts A and B; age 18 to 75 years for cohort C
- ECOG performance status of 0, 1, or 2
- Adequate lung, heart, liver, and kidney function as specified
- Agreement to use contraception during the study and after completion if applicable
- Ability to understand and sign informed consent
You will not qualify if you...
- Cytotoxic chemotherapy or radiotherapy within 2 weeks prior to study (4 weeks for certain drugs)
- Residual severe side effects from prior cancer therapy (Grade >1), except alopecia
- Prior therapies or conditions increasing risk of hepatic veno-occlusive disease
- Currently receiving other investigational agents within 21 days prior to study
- Extramedullary disease in immune privileged sites such as CNS, testes, or eyes
- Recent myocardial infarction (within 2 years)
- Venous thromboembolism within 1 year unless cleared
- Recent stroke or transient ischemic attack within 1 year
- Recent serious gastrointestinal bleeding or ulcers within 6 months
- History of thrombotic microangiopathy or related syndromes
- History of severe reactions to iron infusions or murine antibody products
- Known donor-specific antibodies requiring treatment
- Unable to stop medications affecting liver enzymes during conditioning
- Uncontrolled infections
- Prior hematopoietic or solid organ transplantation
- Medical conditions preventing use of myeloablative radiation
- HIV infection on combination antiretroviral therapy
- Hepatitis B or C infection
- Psychiatric or social conditions limiting study compliance
- Pregnancy or breastfeeding
- History of other malignancies unless disease-free for 5 years or specific exceptions
AI-Screening
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Trial Site Locations
Total: 1 location
1
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Actively Recruiting
Research Team
J
John Koreth, MBBS, DPhil
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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