T-cell Therapy in Patients With PML
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorHannover Medical School
About this trial
There is no approved standard treatment für progressive multifocal leukoencephalopathy (PML). The sponsor of the study is developing a new treatment. For this reason, the investigational medicinal product (IMP) called 'human allogenic HPyV-2-specific T cells' is to be tested in this study. The sponsor wants to find out whether the IMP is safe, influences the neurological status and improves the quality of the life of patients . It is to be investigated whether the IMP can be used to treat the disease and whether it could have an advantage over the standard therapy in terms of survival rate.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults* aged ≥ 18 years with PML (diagnosed ≤ 60 days before screening) associated with one or more of the following risk factors: lymphoproliferative diseases, immunosuppressive therapy, or lymphopenia
Signed written informed consent from subject and/or legal representative
HPyV-2 detection in CSF by PCR analysis or in brain biopsy
Disqualifiers
PML caused by HIV
PML caused by natalizumab
PML occurring within five 5 years after hematopoietic stem-cell transplantation or CAR T cell therapy, or resulting from chronic lymphocytic leukemia (CLL)
Patients who are unable to follow the study protocol, either on their own or with the support of a reliable representative, will be excluded
Trial design
Design model
Single group
Treatments tested in this trial
Application of T-lymphocytes
DrugDosage form: Infusion; Route of administration: Intravenous; Cell dose: 1-2 x 10.000 viable CD3+ T-lymphocytes per kg bodyweight; Application at three timepoints: baseline, after two weeks, after 6 weeks
Treatment groups
23 Participants
are divided into 1 treatment groupGroup A: InterventionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Demonstrate efficacy of treatment
Determine proportion of patients surviving 6 months (overall survival) since diagnosis.
Time frame
6 months after diagnosisSecondary outcomes
1
Safety assessment
Recording of AEs, SAEs, AE of special interest (GvHD, allergic reactions).
Time frame
During 12 months from baseline2
Safety assessment
Determine proportion of patients surviving 12 months (via telephone interview).
Time frame
At 12 months from baseline3
Assessment of potential inflammatory safety concerns
Laboratory examination of differential blood count (cells/microliter).
Time frame
During 6 months from baseline4
Assessment of potential inflammatory safety concerns
Laboratory examination of c-reactive protein (CRP; mg/l).
Time frame
During 6 months from baselineSponsors and contacts
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Source ClinicalTrials.gov