A Multi-center Phase I/II Trial of Memory T Cell Donor Lymphocyte Infusions After Transplantation of CliniMACS® TCRα/β and CD19 Depleted Stem Cell Grafts From Haploidentical Donors for Hematopoietic Cell Transplantation

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 1 month
Maximum Age: 65
Healthy Volunteers: f
View:

∙ 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

Locations
Other Locations
Germany
University Children's Hospital University Clinic Tuebingen
RECRUITING
Tübingen
University Hospital Tuebingen, Department of Hematology, Oncology, Immunology and Rheumatology
RECRUITING
Tübingen
Contact Information
Primary
Wolfgang Bethge, MD, PhD
wolfgang.bethge@med.uni-tuebingen.de
+49 7071 29-83176
Backup
Peter Lang, MD, PhD
peter.lang@med.uni-tuebingen.de
+49 7071 29-81386
Time Frame
Start Date: 2023-04-27
Estimated Completion Date: 2028-12
Participants
Target number of participants: 60
Treatments
Other: Single-arm
Donor lymphocytes from allogeneic donors depleted of CD45RA lymphocytes.
Related Therapeutic Areas
Sponsors
Leads: University Hospital Tuebingen

This content was sourced from clinicaltrials.gov