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NOT YET RECRUITING
NCT05366062
PHASE2

ERC1671 to Treat Malignant Gliomas When Given in Combination With GM-CSF, Cyclophosphamide, Bevacizumab and Pembrolizumab

Sponsor: Epitopoietic Research Corporation

View on ClinicalTrials.gov

Summary

This is a treatment clinical trial to assess the efficacy of ERC1671 in combination with bevacizumab and pembrolizumab in patients with GBM that has progressed following treatment with radiation and temozolomide. Patients will have surgery to collect the maximum amount of GBM tissue that can be reasonably collected. This tissue will be used to manufacturer ERC1671 for the patient. The patients will receive ERC1671 in combination with GM-CSF and cyclophosphamide, in combination with bevacizumab and pembrolizumab.

Official title: Phase II Clinical Trial to Assess the Efficacy of ERC1671 to Treat Malignant Gliomas When Given in Combination With GM-CSF, Cyclophosphamide, Bevacizumab and Pembrolizumab in Patients Who Have Failed Prior Treatment With Radiation and Temozolomide

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

28

Start Date

2022-07-01

Completion Date

2026-07-31

Last Updated

2022-05-13

Healthy Volunteers

No

Interventions

DRUG

ERC1671

ERC1671 is an autologous and allogeneic cells and lysates suspension generated from human glioblastoma (GBM) tumors harvested from patients undergoing surgery for glioblastoma. For each patient the treatment is composed of three allogeneic cells vaccine and lysates vaccine (ERC1671 A, B, C) plus from one autologous cells and lysate (ERC1671D).

DRUG

GM-CSF

Sargramostim (Leukomax®, Leukine®); yeast-derived, recombinant human granulocyte-macrophage colony stimulating factor (rhu GM-CSF)

DRUG

Cyclophosphamide

Cyclophosphamide is an alkylating agent, used for immunopotentiation. This drug is FDA approved and is being used off-label for the condition of hematopoietic stem cell transplant conditioning as an antineoplastic and immunosuppressant agent to modulate immunity.

DRUG

Pembrolizumab

A therapeutic antibody that binds to and blocks PD-1 located on lymphocytes. The receptor is generally responsible for preventing the immune system from attacking the body's own tissues - it is an immune checkpoint inhibitor.

Locations (1)

Bumrungrad International Hospital

Bangkok, Vadhana, Thailand