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Expanded Access for DeltaRex-G for Advanced Solid Tumors, B Cell Lymphoma and Multiple Myeloma

2019-09-20 03:46:41 | BioPortfolio

Summary

Twenty to forty patients will receive DeltaRex-G intravenously at a dose of 3 x 10e11 colony forming units (cfu) or equivalent 5.3 x 10e9 Neo Units (60 ml) per dose three times a week for 3 weeks followed by one week rest. Based on previous Phase 1/2 US based clinical studies, DeltaRex-G does not suppress the bone marrow or cause serious organ dysfunction, and enhanced immune cell trafficking in tumors may cause the tumors to appear larger or new lesions to appear on CT, PET or MRI. Further, tumor stabilization/regression/remission may occur later during the treatment period. Therefore, DeltaRex-G will be continued regardless of CT, PET or MRI results if the patient has clinical benefit and does not have symptomatic disease progression.

Description

Twenty to forty patients with advanced solid malignancies will receive DeltaRex-G intravenously at a dose of 3 x 10e11 colony forming units (cfu) or equivalent 5.3 x 10e9 Neo Units (60 ml) per dose three times a week for 3 weeks followed by one week rest. Based on previous Phase 1/2 US based clinical studies, DeltaRex-G does not suppress the bone marrow or cause serious organ dysfunction, and enhanced immune cell trafficking in tumors may cause the tumors to appear larger or new lesions to appear on CT, PET or MRI. Further, tumor stabilization/regression/remission may occur later during the treatment period. Therefore, DeltaRex-G will be continued regardless of CT, PET or MRI results if the patient has clinical benefit and does not have symptomatic disease progression.

If the patient develops a treatment-related >Grade 3 adverse event, the DeltaRex-G infusions will be held and the patient will be monitored until the toxicity has resolved to

Study Design

Conditions

Advanced Solid Tumors

Intervention

DeltaRex-G

Location

Sarcoma Oncology Research Center, LLC
Santa Monica
California
United States
90403

Status

Temporarily not available

Source

Aveni Foundation

Results (where available)

View Results

Links

Published on BioPortfolio: 2019-09-20T03:46:41-0400

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