A Phase 1/2a Study Evaluating Allocetra-OTS as Monotherapy or in Combination With Anti-PD-1 Therapy for the Treatment of Advanced Solid Tumor Malignancy
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- STATUS
- Recruiting
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- End date
- Jun 25, 2024
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- participants needed
- 48
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- sponsor
- Enlivex Therapeutics RDO Ltd.
Summary
This is an open-label, non-randomized, multicenter, Phase 1/2a study to evaluate the safety and potential efficacy of Allocetra-OTS in the treatment of advanced solid tumor malignancy as monotherapy or in combination with an anti-PD-1 therapy.
Description
Despite the advent of novel targeted and immunotherapeutics for the treatment of solid tumors, many patients remain without cure.
Allocetra-OTS is an immunomodulatory cell-based therapy consisting of allogeneic peripheral blood mononuclear cells that have been modified to be engulfed by macrophages and reprogram them into their homeostatic state.
This is an open-label, non-randomized, multicenter, Phase 1/2a study to evaluate the safety and potential efficacy of Allocetra-OTS in the treatment of advanced solid tumor malignancy as monotherapy (Stage 1), and in combination with an anti-PD-1 therapy (Stage 2).
Allocetra-OTS will be administered systemically or locally (intravenous [IV] or intraperitoneal [IP]) according to the tumor location.
Details
| Condition | Solid Tumor, Peritoneal Metastases, Peritoneal Cancer |
|---|---|
| Treatment | Nivolumab, Allocetra-OTS |
| Clinical Study Identifier | NCT05581719 |
| Sponsor | Enlivex Therapeutics RDO Ltd. |
| Last Modified on | 25 October 2022 |
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