Neoplasms

All Conditions

Digestive System Diseases

Skin and Connective Tissue Diseases

Rare Diseases

Carcinoma

Stomach Neoplasms

Breast Neoplasms

Esophageal Neoplasms

Carcinoma, Adenoid Cystic

Stomach Cancer

Esophageal Cancer

Adenoid Cystic Carcinoma

All Drugs and Chemicals

Antineoplastic Agents

Antibodies

Antibodies, Monoclonal

Trastuzumab

Immunomodulating Agents

Immunoglobulins

Antineoplastic Agents, Immunological

Autologous Antibody-Coupled T Cell Receptor (ACTR) T Cell Product (ACTR707 or ACTR087)

ACTR T Cell Product

Glen Weiss, MD

This is a Phase 1, open-label, multi-center study to assess safety and determine the recommended phase 2 dose (RP2D) of ACTR T cell product (ACTR707 or ACTR087) in combination with trastuzumab, following lymphodepleting chemotherapy in subjects with HER2-positive advanced malignancies.

Study of ACTR T Cell Product in Combination With Trastuzumab in Subjects With HER2-Positive Advanced Solid Tumor Cancers

A Phase 1 Study of an Autologous ACTR T Cell Product in Combination With Trastuzumab, a Monoclonal Antibody, in Subjects With HER2-Positive Advanced Malignancies

Review of DLTs, maximum tolerated dose (MTD), incidence and severity of AEs and clinically significant abnormalities of laboratory values

Levels of inflammatory markers, cytokines/chemokines in blood

trastuzumab serum concentration, Area Under the Curve (AUC), trough levels

Cogent Biosciences, Inc.

Heart and Blood Diseases

Blood and Lymph Conditions

Immune System Diseases

Multiple Myeloma

Neoplasms, Plasma Cell

Lymphoma

Lymphoma, B-Cell

Neoplasms by Histologic Type

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hematologic Diseases

Hemorrhagic Disorders

Lymphoproliferative Disorders

Immunoproliferative Disorders

Lymphosarcoma

B-cell Lymphoma

Subjects who have previously been treated with an ACTR T cell product

Jessica Sachs, MD

Subjects treated with an ACTR product may participate in this long-term follow-up study after the completion of the final scheduled visit in the parent clinical study or other investigational setting, such as compassionate use, named patient Investigational New Drug application, expanded access program, or equivalent setting. No investigational product or treatment will be administered in this study. These subjects will be followed for safety monitoring on a schedule of decreasing frequency through 15 years post-ACTR treatment, in accordance with US FDA Regulatory guidance pertaining to long-term safety follow-up for study subjects receiving recombinant DNA-containing investigational products.

Blood for replication competent retrovirus (RCR) testing

Remaining biological samples from other protocol procedures (e.g., blood for presence of ACTR+ T cells) may also be stored, at the discretion of the sponsor, for potential future biomarker analyses of T cells, DNA, RNA, and other cells or molecules to study immunology or gene therapy.

Optional blood, bone marrow, and tissue samples also may be collected in the event of a subject's death if an autopsy is performed.

Long-Term Follow-Up Study of Subjects Treated With ACTR T Cell Product

Long-Term Follow-Up Study of Subjects Treated With an Autologous T Cell Product Expressing an Antibody-Coupled T-Cell Receptor (ACTR)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Study of ACTR T Cell Product in Combination With Trastuzumab in Subjects With HER2-Positive Advanced Solid Tumor Cancers	NCT03680560	Solid Tumor HER-2 Protein O...	ACTR T Cell Pro... Trastuzumab	18 Years - 75 Years	Cogent Biosciences, Inc.
Long-Term Follow-Up Study of Subjects Treated With ACTR T Cell Product	NCT02840110	B Cell Lymphoma... Multiple Myelom... Solid Tumor HER-2 Protein O...	ACTR T Cell Pro...	18 Years -	Cogent Biosciences, Inc.

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