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CD45RA Depleted DLI After TCRα/β Depleted Haploidentical HCT (CD45RADLIHaplo)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05943067
Recruitment Status : Recruiting
First Posted : July 13, 2023
Last Update Posted : July 17, 2023
Sponsor:
Information provided by (Responsible Party):
University Hospital Tuebingen

Study Description
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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.

Condition or disease Intervention/treatment Phase
Hematologic Malignancy Biological: CD45RA depleted donor lymphocyte infusion (DLI) Phase 1 Phase 2

Detailed Description:

Patients will undergo routine reduced intensity conditioning regimen and intravenous infusion of T-cell receptor alpha/beta (TCRα/β)/CD19 depleted peripheral blood stem cells (not content of clinical trial).

If no graft-versus-host disease (GVHD) occurs, patients receive the trial-related memory T cell donor lymphocyte infusion (DLI) on Day 30 after transplantation.

In a dose finding part (phase I) escalating doses will be applied in cohorts of three (three plus three design) patients with a maximum of 18 patients for three dose levels (dose level 1-3). A fourth lower dose level (dose level 0) is started, if >=2 out of 6 patients with dose level 1 develop aGVHD III/IV. The maximum tolerated dose (MTD) will be used for the confirmatory part (phase II) of the study.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : April 27, 2023
Estimated Primary Completion Date : January 2028
Estimated Study Completion Date : December 2028

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Organ Donation

Arms and Interventions
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Arm Intervention/treatment
Single-arm
Donor lymphocytes from allogeneic donors depleted of CD45RA lymphocytes.
 Biological: CD45RA depleted donor lymphocyte infusion (DLI)
CD45RA depleted donor lymphocyte infusion (DLI) after TCRα/β depleted haploidentical HCT


Outcome Measures
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Primary Outcome Measures :
  1. Phase I, dose escalation [ Time Frame: 100 days ]
    Safety and toxicity of CD45RA depleted DLI as defined by infusional toxicities and acute GVHD grad III-IV.

  2. Phase II, extension phase [ Time Frame: 100 days ]
    Acute graft-versus-host disease grade III-IV defined as GVHD occurring within 100 days after HCT


Eligibility Criteria
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Ages Eligible for Study:   8 Weeks to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05943067


Contacts
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Contact: Wolfgang Bethge, MD, PhD +49 7071 29-83176 wolfgang.bethge@med.uni-tuebingen.de
Contact: Peter Lang, MD, PhD +49 7071 29-81386 peter.lang@med.uni-tuebingen.de

Locations
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Germany
University Hospital Tuebingen, Department of Hematology, Oncology, Immunology and Rheumatology Recruiting
Tuebingen,, Germany, 72076
Contact: Wolfgang Bethge, MD, PhD    +49 (0) 7071 29-83176    wolfgang.bethge@med.uni-tuebingen.de   
Contact: Christoph Faul, MD, PhD    +49 (0) 7071 29-84087    christoph.faul@med.uni-tuebingen.de   
University Children's Hospital University Clinic Tuebingen Recruiting
Tuebingen, Germany, 72076
Contact: Peter Lang, MD, PhD    +49 7071 29-81386    peter.lang@med.uni-tuebingen.de   
Contact: Michaela Döring, MD, PhD    +49 7071 29-81386    michaela.doering@med.uni-tuebingen.de   
Sponsors and Collaborators
University Hospital Tuebingen
More Information
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Responsible Party: University Hospital Tuebingen
ClinicalTrials.gov Identifier: NCT05943067    
Other Study ID Numbers: CD45RADLIHaplo
First Posted: July 13, 2023    Key Record Dates
Last Update Posted: July 17, 2023
Last Verified: July 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hematologic Neoplasms
Neoplasms
Neoplasms by Site
Hematologic Diseases