EUCTR2022-001080-27-DEActive, not recruitingPhase 1
A multi-center phase I/II trial of memory T cell donor lymphocyte infusions after transplantation of CliniMACS TCRa/ß and CD19 depleted stem cell grafts from haploidentical donors for hematopoietic cell transplantation
niversity Hospital Tuebingen0 sites60 target enrollmentStarted: April 12, 2022Last updated:
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 60
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •Adult and paediatric 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 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
- •No signs of acute GVHD on day 30 (day of infusion of DLI/IMP) after haploidentical HHCT
- •Patients aged =1 year to =65 years
- •For safety reasons, dose escalation part within this study should only be performed for adults and older children (>6 years). The second part of the study, with already evaluated safe dose level, also younger children (=1 year) can be included.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 2
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 30
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
Exclusion Criteria
- •Age >65 years or <1 year
- •Patients with progressive disease prior HCT
- •<3 months after preceding hematopoietic cell transplantation (HCT)
- •Treatment with T-cell or IL-2 targeted medication (e.g. alemtuzumab, basiliximab) within 60 days prior to study product infusion
- •Continuous treatment with prednisolone (or alternative glucocorticosteroid e.g. dexamethasone, short term use =3 days for other indication as GVHD allowed) within two weeks prior study product infusion (DLI).
- •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 leukencephalopathy, active CNS infection)
- •Note: For patients with HLH or Malignant Osteopetrosis or other 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 CommonToxicity 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
Investigators
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