OncoMatch/Clinical Trials/NCT04678401
IS-free Treg HaploHCT
Is NCT04678401 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments for stem cell transplant complications.
Treatment: Mesna · Treg-enriched donor cell · Fludarabine · Thiotepa · Cyclophosphamide · Unmodified donor T Cell · Melphalan — 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
Check if I qualifyExtracted eligibility criteria
Cancer type
Acute Myeloid Leukemia
Myelodysplastic Syndrome
Biomarker criteria
Required: TP53 any mutation
Ultra high-risk AML or MDS that meets definition of 'Myeloid Neoplasms with mutated TP53' per 2022 International Consensus Classification
Required: TP53 multi-hit or complex karyotype (CK+) mutated
Ultra high-risk AML or MDS that meets definition of 'Myeloid Neoplasms with multi-hit or complex karyotype (CK+) mutated TP53' per 2022 International Consensus Classification
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: cytotoxic chemotherapy (3+7 chemotherapy, HMA therapy)
despite at least 1 prior line of therapy (e.g., 3+7 chemotherapy, HMA therapy)
Cannot have received: cytotoxic chemotherapy
Exception: hydroxyurea, HMA, FDA-approved novel targeted agents (e.g., venetoclax, FLT-3 inhibitors, IDH 1/2 inhibitors) permitted up to a day prior to start of HCT conditioning
Participants who have had cytotoxic chemotherapy or radiotherapy within 2 weeks (4 weeks for nitrosoureas or mitomycin C) prior to entering the study
Cannot have received: radiation therapy
Participants who have had cytotoxic chemotherapy or radiotherapy within 2 weeks (4 weeks for nitrosoureas or mitomycin C) prior to entering the study
Cannot have received: investigational agent
Exception: unless cleared by the study PI
Participants who are receiving any other investigational agents within 21 days (or 5 half-lives) prior to study entry, whichever is longer, unless cleared by the study PI
Cannot have received: Mylotarg or other therapies associated with increased risk of hepatic veno-occlusive disease (VOD) (Mylotarg)
Participants who received Mylotarg or other therapies associated with increased risk of hepatic veno-occlusive disease (VOD) or have known prior or active VOD
Cannot have received: allogeneic or autologous hematopoietic cell transplantation
Recipients of prior allogeneic or autologous hematopoietic cell transplantation, or solid organ transplantation
Cannot have received: solid organ transplantation
Recipients of prior allogeneic or autologous hematopoietic cell transplantation, or solid organ transplantation
Lab requirements
Blood counts
Adequate organ and marrow function as defined below
Kidney function
Serum Creatinine within normal institutional limits or creatinine clearance >50 mL/min/1.73 m2 for participants with creatinine levels above institutional normal
Liver function
Total bilirubin within normal institutional limits (exception permitted in Gilbert's Syndrome after discussion with study PI, on a case-by-case basis); and AST (SGOT)/ALT (SGPT) <2x institutional upper limit of normal
Cardiac function
Cardiac Ejection Fraction ≥ 45%, and no evidence of pulmonary hypertension
Adequate organ and marrow function as defined below: Pulmonary Function: FEV1, FVC and DLCO ≥ 60% of predicted (corrected for hemoglobin) Cardiac Ejection Fraction ≥ 45%, and no evidence of pulmonary hypertension Hepatic: Total bilirubin within normal institutional limits (exception permitted in Gilbert's Syndrome after discussion with study PI, on a case-by-case basis); and AST (SGOT)/ALT (SGPT) <2x institutional upper limit of normal Renal: Serum Creatinine within normal institutional limits or creatinine clearance >50 mL/min/1.73 m2 (see Appendix B) for participants with creatinine levels above institutional normal.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Dana Farber Cancer Institute · Boston, Massachusetts
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