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

Stopped early · Phase 1

Conditions studied: Lymphoma

In brief

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.

Key facts

Study ID

NCT03189836

Run by

Cogent Biosciences, Inc.

People needed

26

Starts

2017-10-04

Expected to finish

2020-09-21

Last updated by the study team

2021-10-11

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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