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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stage 1 (Allocetra-OTS monotherapy) | Experimental | Dose escalation of Allocetra-OTS up to 10 x 10^9 cells by IV or IP administration. |
|
| Stage 2.1 (Allocetra-OTS in combination with anti-PD-1 therapy) | Experimental | Dose escalation of Allocetra-OTS up to 10 x 10^9 cells by IV or IP administration, with IV nivolumab 240 mg. |
|
| Stage 2.2 (Allocetra-OTS in combination with anti-PD-1 therapy) | Experimental | Dose escalation of Allocetra-OTS up to 10 x 10^9 cells by IV or IP administration, with IV tislelizumab 200 mg. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Allocetra-OTS | Drug | Allocetra-OTS is a cell-based therapy consisting of non-HLA matched allogeneic peripheral blood mononuclear cells, derived from a healthy human donor following a leukapheresis procedure, induced to an apoptotic stable state. |
| Measure | Description | Time Frame |
|---|---|---|
| Safety of Allocetra-OTS | Characterize the safety of Allocetra-OTS based on the dose-limiting toxicities (DLTs) of Allocetra-OTS as monotherapy or in combination with anti-PD1 therapy. | 3-5 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate (ORR)/Best Overall Response Rate (BORR) | Overall Response Rate (ORR)/Best Overall Response Rate (BORR) (percentage of patients who achieve best response of complete response [CR] or partial response [PR]). | 12 months |
| Clinical benefit rate (CBR) |
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Inclusion Criteria:
Patients must have histologically or cytologically confirmed locally advanced, unresectable or metastatic solid tumors, that have relapsed or have been refractory to available approved therapies, or patients who are not eligible for or declined additional standard of care systemic therapy.
Patients with peritoneal carcinomatosis can be eligible if an appropriate IP catheter or port can be placed.
Patients must have measurable disease.
Age ≥ 18 years old.
ECOG performance status ≤1.
Adequate renal function, hepatic function, and bone marrow function.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Roni Shapira, MD | Sheba Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rambam Medical Center | Haifa | Israel | ||||
| Hadassah Medical Center |
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| Nivolumab | Drug | Immune checkpoint inhibitor (anti-PD-1 antibody) |
|
| Tislelizumab | Drug | Immune checkpoint inhibitor (anti-PD-1 antibody) |
|
Clinical benefit rate (CBR) (percentage of patients who achieve best response of CR, PR or stable disease [SD]). |
| 12 months |
| Duration of response (DoR) | Duration of response (DoR), defined as the time from first documented evidence of CR or PR until disease progression or death. | 12 months |
| Time to response (TTR) | Time to response (TTR), defined as the time to the first documented CR or PR. | 12 months |
| Progression-free survival (PFS) | Progression-free survival (PFS), defined as the time to disease progression or death due to any cause. | 12 months |
| Overall survival (OS) | Overall survival (OS) defined as the time to death due to any cause. | 12 months |
| Jerusalem |
| Israel |
| Sheba Medical Center | Ramat Gan | Israel |
| Sourasky Medical Center | Tel Aviv | Israel |
| ClĂnica Universidad de Navarra | Madrid | Spain |
| NEXT Madrid | Madrid | Spain |
| ID | Term |
|---|---|
| D000077594 | Nivolumab |
| C000707970 | tislelizumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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