Hematopoietic stem cell transplant using haploidentical donor grafts depleted of TCRα/β and CD45RA

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a single-center, open-label, pilot study enrolling 12 to 18 adults with high-risk hematologic malignancies who need allogeneic hematopoietic stem cell transplantation and lack an HLA-matched donor. The approach uses CD45RA-depleted and TCRα/β-depleted grafts from haploidentical donors, prepared with the CliniMACS Prodigy system. It is a non-randomized, single-arm design to evaluate feasibility, safety, and early signals of efficacy. Eligible patients are adults 18 to 75 without recent autologous transplant, significant organ dysfunction, active infections, uncontrolled hypertension, HIV, or donor-specific anti-HLA antibodies. The study is sponsored by Miltenyi Biotec with City of Hope as a collaborating center, conducted at City of Hope in Duarte, CA.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Patients, between 18 years to 75 years of age, with high-risk hematological malignancy requiring an allogeneic hematopoietic stem cell transplantation (AlloHCT), but do not have an HLA-matched donor available

Exclusion Criteria:

* \<3 months after preceding autologous transplantation or prior AlloHCT
* History of neurological impairment (active seizures, severe peripheral neuropathy, signs of leukoencephalopathy, active CNS infection)
* Active fungal infections with radiological and clinical progression
* Liver function abnormalities with bilirubin \>2 mg/dL and elevation of transaminases higher than 400 U/L
* Chronic active viral hepatitis
* Cardiac dysfunction: adult patients ejection fraction \<50% on echocardiography
* Patients with uncontrolled, \>grade II hypertension (per Common Toxicity Criteria, CTC)
* Creatinine clearance \<60 mL/min/1.73m2
* Respiratory failure necessitating supplemental oxygen
* HIV infection
* Positive anti-donor HLA antibody
* Treatment with checkpoint inhibitors in the period between 3 months prior to and 3 months after transplantation
* Female patients who are pregnant or breast feeding, or adults of reproductive potential not willing to use an effective method of birth control during study treatment and for at least 12 months thereafter. Note: Women of childbearing potential must have a negative serum pregnancy test at study entry
* Concurrent severe or uncontrolled medical disease (e.g., uncontrolled diabetes, myocardial infarction within 6 months prior to the study) which by assessment of the treating physician could compromise participation in the study
* Patients with a history of psychiatric illness or a condition which could interfere with their ability to understand the requirements of the study (this includes alcoholism/drug addiction).
* Patients unwilling or unable to comply with the protocol or unable to give informed consent
* Treatment with any investigational product within 4 weeks prior to study treatment

Where it's running

• City of Hope
  Duarte, California, United States Recruiting

Study contacts

• Study coordinator: Clinical Trial Manager
• Email: clinicaltrials.gov@miltenyi.com
• Phone: +49 22048306820

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Lower Dose Cyclophosphamide After Haploidentical Stem Cell Transplant

  This trial tests whether giving half the usual amount of cyclophosphamide after haploidentical stem cell transplantation can still prevent GVHD in adults with blood cancers.

  Recruiting Phase 2 Tata Memorial Centre · Navi Mumbai, Maharashtra and 1 other locations · NCT07719946

• Chlorophyllin to reduce mouth sores before allogeneic stem cell transplant

  This phase II study tests whether taking chlorophyllin by mouth can lower the chances and severity of mouth ulcers in patients aged 12–65 undergoing radiation-based conditioning before a first allogeneic stem cell transplant.

  Recruiting Phase 2 Tata Memorial Centre · Navi Mumbai, Maharashtra · NCT07709195

• First-in-human test of DS3790a for hematological malignancies

  This first-in-human trial will test DS3790a alone and with other drugs to see if it's safe, how it behaves in the body, and whether it helps adults with hematological malignancies.

  Recruiting at 8 sites Phase 1/2 Daiichi Sankyo · New York, New York and 7 other locations · NCT07220616

• 18F‑Pentixafor PET imaging for blood cancers

  This will test whether 18F‑Pentixafor PET scans help diagnose, stage, and check treatment response in adults with suspected or confirmed hematologic malignancies.

  Recruiting First Affiliated Hospital of Zhejiang University · Hangzhou, Zhejiang · NCT07122674

• Improving GVHD prevention after donor stem cell transplant

  This study will test whether a lower dose versus the standard dose of post-transplant cyclophosphamide, given with sirolimus and MMF, improves quality of life for people aged 60 and older having a reduced-intensity allogeneic stem cell transplant.

  Recruiting Phase 2 University of Nebraska · Omaha, Nebraska · NCT06799195

• Long-term follow-up for patients treated with Galapagos CAR T-cell therapies

  This study is checking how well Galapagos CAR T-cell therapies work and their safety for patients over 15 years after treatment.

  Recruiting at 11 sites Phase 3 Lakefront Biotherapeutics NV · Boston, Massachusetts and 10 other locations · NCT06652633

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.