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

NCT ID: NCT03189836

Last Updated: 2021-10-11

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-10-04
• Study Completion Date: 2020-09-21

Brief Summary

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.

Conditions

Lymphoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ACTR707 in combination with rituximab

Group Type: EXPERIMENTAL

ACTR707

Intervention Type: BIOLOGICAL

autologous T cell product

rituximab

Intervention Type: BIOLOGICAL

CD20-directed cytolytic antibody

Interventions

ACTR707

autologous T cell product

Intervention Type: BIOLOGICAL

rituximab

CD20-directed cytolytic antibody

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• signed written informed consent obtained prior to study procedures
• histologically-confirmed relapsed or refractory CD20+ B-cell lymphoma of one of the following types, with documented disease progression or recurrence following the immediate prior therapy: DLBCL (regardless of cell of origin or underlying molecular genetics), MCL, PMBCL, Gr3b-FL, TH-FL (prior dx of FL before transforming to DLBCL).
• biopsy-confirmed CD20+ expression of the underlying malignancy with disease progression following immediate prior therapy
• at least 1 measurable lesion on imaging.
• must have received adequate prior therapy for the underlying CD20+ B-cell lymphoma, defined as an anti-CD20 mAb in combination with an anthracycline-containing chemotherapy regimen (i.e. chemo-immunotherapy) and at least one of the following:

• biopsy-proven refractory disease after frontline chemo-immunotherapy
• relapse within 1 year from frontline chemo-immunotherapy and ineligible for autologous hematopoietic stem cell transplant (auto-HSCT)
• for subjects with DLBCL, PMBCL, and Gr3b-FL: relapsed or refractory disease following at least 2 prior regimens or following an auto-HSCT
• for subjects with TH-FL: relapsed or refractory disease following at least 2 prior regimens or following an auto-HSCT. At least 1 prior regimen with an anti-CD20 mAb in combination with chemotherapy is required following documented transformation
• for subjects with MCL (confirmed with cyclin D1 expression or evidence of t(11;14) by cytogenetics, fluorescent in situ hybridization (FISH) or polymerase chain reaction (PCR): relapsed or refractory disease after at least 1 prior regimen with chemo-immunotherapy (prior auto-HSCT is allowable)
• ECOG 0 or 1
• life expectancy of at least 6 months
• platelet count greater than 50,000/µL

Exclusion Criteria

• known active central nervous system (CNS) involvement by malignancy.
• prior treatment as follows:

• alemtuzumab within 6 months of enrollment
• fludarabine, cladribine, or clofarabine within 3 months of enrollment
• external beam radiation within 2 weeks of enrollment
• mAb (including rituximab) within 2 weeks of enrollment
• other lymphotoxic chemotherapy (including steroids except as below) within 2 weeks of enrollment
• experimental agents within 3 half-lives prior to enrollment, unless progression is documented on therapy
• clinically significant cardiac disease
• clinically significant active infection
• clinically significant CNS disorder
• clinical history, prior diagnosis, or overt evidence of autoimmune disease
• known bone marrow involvement due to underlying malignant disease, in dose-escalation phase only

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cogent Biosciences, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jessica Sachs, MD

Role: STUDY_DIRECTOR

Cogent Biosciences, Inc.

Locations

Banner MD Anderson Cancer Center

Gilbert, Arizona, United States

Yale University

New Haven, Connecticut, United States

Emory University, Winship Cancer Institute

Atlanta, Georgia, United States

Loyola University

Maywood, Illinois, United States

Indiana Bone and Marrow Transplantation

Indianapolis, Indiana, United States

University of Maryland

Baltimore, Maryland, United States

University of Minnesota

Minneapolis, Minnesota, United States

Ohio State University

Columbus, Ohio, United States

Tennessee Oncology - Nashville

Nashville, Tennessee, United States

The University of Texas MD Anderson Cancer Center

Houston, Texas, United States

Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Countries

United States

References

Ernst M, Oeser A, Besiroglu B, Caro-Valenzuela J, Abd El Aziz M, Monsef I, Borchmann P, Estcourt LJ, Skoetz N, Goldkuhle M. Chimeric antigen receptor (CAR) T-cell therapy for people with relapsed or refractory diffuse large B-cell lymphoma. Cochrane Database Syst Rev. 2021 Sep 13;9(9):CD013365. doi: 10.1002/14651858.CD013365.pub2.

Reference Type: DERIVED

PMID: 34515338 (View on PubMed)

Other Identifiers

ATTCK-20-03

Identifier Type: -

Identifier Source: org_study_id