CD45RA Depleted DLI After TCRα/β Depleted Haploidentical HCT

Launched by UNIVERSITY HOSPITAL TUEBINGEN · Jul 4, 2023

Keywords

ClinConnect Summary

This clinical trial is investigating a new treatment approach for patients with certain blood cancers, known as hematologic malignancies, who are in remission or have stable disease. The trial focuses on the safety and potential side effects of a special type of donor lymphocyte infusion (DLI) that has been modified to help boost the immune response after patients have received a specific kind of stem cell transplant. This treatment aims to improve outcomes for patients with conditions such as acute myeloid leukemia (AML), acute lymphoid leukemia (ALL), Hodgkin's disease, non-Hodgkin's lymphoma, myelodysplastic syndromes, and multiple myeloma.

To be eligible for this trial, patients must be between the ages of 8 weeks and 65 years and have a specific type of hematologic malignancy that is either in complete remission, partial remission, or stable. However, there are several criteria that could exclude someone from participating, such as having an active infection or certain medical conditions that could complicate treatment. Participants in the trial will receive close monitoring to ensure their safety and will be part of a study designed to better understand how this treatment works. It's important for patients and their families to discuss any questions or concerns with their healthcare team before considering participation.

Gender

ALL

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