CD45RA Depleted DLI After TCRα/β Depleted Haploidentical HCT

NCT05943067 | Recruiting Phase 1 DMC

• 1 other identifier: CD45RADLIHaplo
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

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.

Conditions

Hematologic Malignancy

Outcome Measures

Primary Outcomes (2)

• Phase I, dose escalation

  Safety and toxicity of CD45RA depleted DLI as defined by infusional toxicities and acute GVHD grad III-IV.

  100 days

• Phase II, extension phase

  Acute graft-versus-host disease grade III-IV defined as GVHD occurring within 100 days after HCT

  100 days

Study Arms (1)

Single-arm

OTHER

Donor lymphocytes from allogeneic donors depleted of CD45RA lymphocytes.

Biological: CD45RA depleted donor lymphocyte infusion (DLI)

Interventions

CD45RA depleted donor lymphocyte infusion (DLI) BIOLOGICAL

CD45RA depleted donor lymphocyte infusion (DLI) after TCRα/β depleted haploidentical HCT

Single-arm

Eligibility Criteria

• Age: 8 Weeks - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• University Hospital Tuebingen: lead

Study Sites (2)

University Children's Hospital University Clinic Tuebingen

Tübingen, 72076, Germany

RECRUITING

University Hospital Tuebingen, Department of Hematology, Oncology, Immunology and Rheumatology

Tübingen, 72076, Germany

RECRUITING

MeSH Terms

Conditions

Hematologic Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Central Study Contacts

Wolfgang Bethge, MD, PhD

CONTACT

+49 7071 29-83176; wolfgang.bethge@med.uni-tuebingen.de

Peter Lang, MD, PhD

CONTACT

+49 7071 29-81386; peter.lang@med.uni-tuebingen.de

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 4, 2023
• First Posted: July 13, 2023
• Study Start: April 27, 2023
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: April 27, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

DE (2)