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

Neoplasms by Histologic Type

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hematologic Diseases

Hemorrhagic Disorders

Lymphoproliferative Disorders

Immunoproliferative Disorders

ACTR087

B-cell maturation antigen (BCMA)-directed antibody

SEA-BCMA

Jessica Sachs, MD

This is a phase 1, multi-center, single-arm, open-label study evaluating the safety, tolerability, and anti-myeloma activity of ACTR087 (an autologous T cell product) in combination with SEA-BCMA (a monoclonal antibody) in subjects with relapsed or refractory Multiple Myeloma.

Study of ACTR087 in Combination With SEA-BCMA in Subjects With Relapsed or Refractory Multiple Myeloma

A Phase 1 Study of ACTR087, an Autologous T Cell Product, in Combination With SEA-BCMA, a Monoclonal Antibody, in Subjects With Relapsed or Refractory Multiple Myeloma

Composite outcome measure assessed by committee review of dose limiting toxicities (DLTs), incidence and severity of AEs and clinically significant abnormalities of laboratory values

Review of DLTs, Maximum tolerated contour (MTC), incidence and severity of AEs and clinically significant abnormalities of laboratory values

Review of all TEAEs, including incidence and severity of AEs, DLTs and clinically significant abnormalities of laboratory values

Levels of inflammatory markers, cytokines/chemokines

Seagen Inc.

Lymphoma

Lymphoma, B-Cell

Lymphatic Diseases

Lymphosarcoma

B-cell Lymphoma

Antirheumatic Agents

Rituximab

Immunologic Factors

ACTR707

rituximab

This is a phase 1, multi-center, single-arm, open-label study evaluating the safety and anti-lymphoma activity of an autologous T cell product (ACTR707) in combination with rituximab in subjects with refractory or relapsed CD20+ B cell lymphoma.

Study of ACTR707 in Combination With Rituximab in Subjects With Relapsed or Refractory B Cell Lymphoma

Phase 1 Study of ACTR707, an Autologous T Cell Product, in Combination With Rituximab, in Subjects With Relapsed or Refractory CD20+ B Cell Lymphoma

Dose-limiting toxicities, MTD, incidence and severity of AEs and clinically significant abnormalities of laboratory values

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
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.
Study of ACTR087 in Combination With SEA-BCMA in Subjects With Relapsed or Refractory Multiple Myeloma	NCT03266692	Multiple Myelom... Multiple Myelom... Refractory Mult...	ACTR087 SEA-BCMA	18 Years - 80 Years	Cogent Biosciences, Inc.
Study of ACTR707 in Combination With Rituximab in Subjects With Relapsed or Refractory B Cell Lymphoma	NCT03189836	Lymphoma	ACTR707 rituximab	18 Years - 80 Years	Cogent Biosciences, Inc.
Study of ACTR707 in Combination With Rituximab in Subjects With Relapsed or Refractory B Cell Lymphoma	NCT03189836	Lymphoma	ACTR707 rituximab	18 Years - 80 Years	Cogent Biosciences, Inc.

Spots Global Cancer Trial Database for t cell product