NCT05943067 CD45RA Depleted DLI After TCRα/β Depleted Haploidentical HCT
| NCT ID | NCT05943067 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | University Hospital Tuebingen |
| Condition | Hematologic Malignancy |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2023-04-27 |
| Primary Completion | 2028-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 60 participants in total. It began in 2023-04-27 with a primary completion date of 2028-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The purpose of this clinical trial is to examine safety and toxicity of CD45RA depleted donor lymphocyte infusion (DLI) after transplantation of TCRα/β/CD19 depleted peripheral blood stem cells.
Eligibility Criteria
Inclusion Criteria: Adult and pediatric patients with hematological malignancies in complete remission (CR), partial remission (PR) or with stable disease * Acute myeloid leukemia (AML): * Patients with high-risk AML in first complete remission (CR1) * Patients with relapsed or primary therapy-refractory AML * Acute lymphoid leukemia (ALL): * Patients with high-risk ALL in CR1 * Patients with relapsed or primary refractory ALL * Hodgkin's disease: Patients with relapsed or primary refractory Hodgkin's disease * Non-Hodgkin's lymphoma: Patients with relapsed or primary refractory Non- Hodgkin's lymphoma * Myelodysplastic Syndrome (MDS)/ Myeloproliferative Syndrome (MPS): °Patients with refractory MDS/MPS * Multiple myeloma (MM): Patients with relapsed or refractory multiple myeloma Exclusion Criteria: * Age \>65 years or \<8 weeks * Patients with progressive disease prior hematopoietic cell transplantation (HCT) * \<3 months after preceding HCT * Treatment with T-cell or Interleukin-2 (IL-2) targeted medication (e.g. alemtuzumab, basiliximab) within 60 days prior to study product infusion * Treatment with prednisolone at \>2 mg/kg/day (or equivalent dosing of alternative glucocorticosteroids) at time of study product infusion. * Known allergy/hypersensitivity to any component of the study product * Treatment with another investigational drug within one month before inclusion * History of neurological impairment (active seizures, severe peripheral neuropathy, signs of leukoencephalopathy, active Central Nervous System (CNS) infection) Note: For patients with heavy pretreatment with irradiation or intrathecal chemotherapy pre-transplant CNS MRI and neurological consultation are mandatory. * 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 * Ejection fraction \<40% or Shortening fraction \<20% on echocardiography. Patients with \> grade II hypertension by Common Toxicity Criteria (CTC) * Creatinine clearance below threshold defined for stem cell transplantation according to local clinical standard * Respiratory failure necessitating supplemental oxygen * HIV infection * 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, congestive heart failure, myocardial infarction within 6 months prior to the study, unstable and uncontrolled hypertension, chronic renal disease, or active uncontrolled infection) 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05943067 clinical trial?
This trial is open to participants of all sexes, aged 8 Weeks or older, up to 65 Years, studying Hematologic Malignancy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05943067 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT05943067 currently recruiting?
Yes, NCT05943067 is actively recruiting participants. Contact the research team at wolfgang.bethge@med.uni-tuebingen.de for enrollment information.
Where is the NCT05943067 trial being conducted?
This trial is being conducted at Tübingen, Germany, Tübingen, Germany.
Who is sponsoring the NCT05943067 clinical trial?
NCT05943067 is sponsored by University Hospital Tuebingen. The trial plans to enroll 60 participants.