At a glance

ClinicalIndex Comparison Record

Phase 1Completed· 67 enrolled

Drug / intervention

AV0113 DC-CIT +1 morebiological

Likely dose

Not stated in record

Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02533895

NCT02533895Phase 1Completed

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Monocyte-derived Dendritic Cells Loaded With Tumour Cell Lysates for the Treatment of Refractory Solid Tumours of Childhood

Activartis Biotech·interventional·Posted Aug 27, 2015·Updated Dec 29, 2015

In Brief

A Phase 1 clinical trial evaluating AV0113 DC-CIT and Data evaluation for Childhood Solid Tumor. Completed, enrolled 67 participants across 2 sites.

Detailed Summary

This is an un-blinded Phase 1 study in which 21 patients suffering from solid advanced paediatric malignancies (14 sarcoma and 7 non-sarcoma patients) are treated with AV0113, an anti-tumour immune therapy with autologous Dendritic Cells (DCs) loaded with tumour cell lysates, in order to investigate its safety and feasibility. For obtaining a clearer picture of AV0113's utility in the treatment of bone and soft tissue sarcoma, a long-term (LT) follow-up investigation of the 14 sarcoma patients, which will be treated using the AV0113 Dendritic Cell Cancer Immune Therapy (DC-CIT) technology is planned, in order to gather first evidence for a potential LT effect of DC-CIT with AV0113. Furthermore, a comparison of the 14 sarcoma patients treated with AV0113 DC-CIT with a cohort of matched historic control patients that were treated using standard of care will be conducted. It is planned to analyse 42 historic control sarcoma patients that will be matched for disease, recurrences, relapses etc.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsChildhood Solid Tumor

CountriesAustria

Collaborators--

Timeline

Phase 1CompletedFinished

2000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027

Enrollment StartFeb 2000

Primary CompletionAug 2015

First PostedAug 2015

Study CompletionOct 2015

TodayJul 2026

First PostedAug 27, 2015

Enrollment StartFeb 1, 2000

Primary CompletionAug 1, 2015

Study CompletionOct 1, 2015

TodayJul 2, 2026

Enrollment to primary: 15.5 yearsPosted 10.8 years ago

Interventions

AV0113 DC-CITbiological

Mature loaded DCs will be injected intra-nodally into tumour free lymph nodes or subcutaneously close to tumour free lymph nodes at weekly intervals for at least 6 weeks.

Data evaluationother

For obtaining a clearer picture of AV0113's utility in the treatment of bone and soft tissue sarcoma, a LT follow-up investigation of the 14 Sarcoma patients, which will be treated using the AV0113 DC-CIT technology, is planned, in order to gather first evidence for a potential LT effect of DC-CIT with AV0113. Furthermore, a comparison of the 14 sarcoma patients treated with AV0113 DC-CIT with a cohort of matched historic control patients that were treated using standard of care will be conducted. It is planned to analyse 42 control sarcoma patients that will be matched for disease, recurrences, relapses etc