Actively Recruiting
A Multi-center Phase I/II Trial of Memory T Cell Donor Lymphocyte Infusions After Transplantation of CliniMACS ae TCRb1/b2 and CD19 Depleted Stem Cell Grafts From Haploidentical Donors for Hematopoietic Cell Transplantation
Led by University Hospital Tuebingen · Updated on 2025-04-27
60
Participants Needed
2
Research Sites
47 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This clinical trial focuses on patients with hematologic malignancies who have undergone transplantation using T-cell receptor alpha/beta (TCRb1/b2) and CD19 depleted peripheral blood stem cells from haploidentical donors. The purpose is to study the safety and toxicity of donor lymphocyte infusions (DLI) depleted of CD45RA lymphocytes, following this transplantation. The trial includes both a dose-finding phase (phase I) and a confirmatory extension phase (phase II) to establish the maximum tolerated dose of the memory T cell DLI. Patients first receive a standard reduced intensity conditioning regimen followed by an intravenous infusion of TCRb1/b2/CD19 depleted stem cells, which is not part of the trial treatment. If patients do not develop graft-versus-host disease (GVHD), they receive the study-related CD45RA depleted memory T cell donor lymphocyte infusion approximately 30 days after transplantation. The phase I dose escalation part enrolls patients in cohorts of three with up to three dose levels, and a potential lower dose level if higher doses cause severe GVHD. Phase II uses the maximum tolerated dose identified to further evaluate the treatment. Participants will be closely monitored for safety and toxicity during the first 100 days after infusion in both phases. Assessments include clinical evaluations and laboratory tests to detect any adverse effects or graft-versus-host disease. The total duration of participant involvement covers these 100-day periods post-infusion, during which the primary outcomes related to dose escalation and treatment safety are measured. This study is sponsored by the University Hospital Tuebingen and includes both adult and pediatric patients aged 8 weeks to 65 years.
CONDITIONS
Brief Title
CD45RA Depleted DLI After TCRα/β Depleted Haploidentical HCT
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult and pediatric patients with hematological malignancies in complete remission (CR), partial remission (PR) or with stable disease
- Patients with high-risk acute myeloid leukemia (AML) in first complete remission (CR1), relapsed or primary therapy-refractory AML
- Patients with high-risk acute lymphoid leukemia (ALL) in CR1, relapsed or primary refractory ALL
- Patients with relapsed or primary refractory Hodgkin's disease
- Patients with relapsed or primary refractory Non-Hodgkin's lymphoma
- Patients with refractory myelodysplastic syndrome (MDS) or myeloproliferative syndrome (MPS)
- Patients with relapsed or refractory multiple myeloma (MM)
You will not qualify if you...
- Age greater than 65 years or less than 8 weeks
- Patients with progressive disease prior to hematopoietic cell transplantation (HCT)
- Less than 3 months after preceding hematopoietic cell transplantation
- Treatment with T-cell or interleukin-2 targeted medications within 60 days prior to study product infusion
- Treatment with prednisolone at more than 2 mg/kg/day or equivalent glucocorticosteroids at time of infusion
- Known allergy or hypersensitivity to any component of the study product
- Treatment with another investigational drug within one month before inclusion
- History of neurological impairment including active seizures or severe neuropathy
- Fungal infections with progression
- Liver abnormalities with bilirubin over 2 mg/dL or transaminases over 400 U/L
- Chronic active viral hepatitis
- Heart dysfunction with ejection fraction less than 40% or shortening fraction less than 20%, or grade II hypertension
- Creatinine clearance below local standard for stem cell transplantation
- Respiratory failure requiring supplemental oxygen
- HIV infection
- Female patients who are pregnant, breastfeeding, or not willing to use effective birth control during and for 12 months after study
- Severe or uncontrolled medical diseases that may compromise study participation
- History of psychiatric illness or conditions interfering with study understanding
- Patients unable or unwilling to comply with protocol or give informed consent
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day 30 after transplantation
Participants receive a memory T cell donor lymphocyte infusion (DLI) approximately 30 days after transplantation if no graft-versus-host disease occurs.
1 infusion visit (in-person)
Duration - 100 days
Participants are monitored for safety and treatment outcomes for 100 days after the donor lymphocyte infusion.
Weekly visits during the follow-up period
Trial Site Locations
Total: 2 locations
1
University Children's Hospital University Clinic Tuebingen
Tübingen, Germany, 72076
Actively Recruiting
2
University Hospital Tuebingen, Department of Hematology, Oncology, Immunology and Rheumatology
Tübingen, Germany, 72076
Actively Recruiting
Research Team
W
Wolfgang Bethge, MD, PhD
P
Peter Lang, MD, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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