Phase 1 Study of ACTR087, Autologous T Lymphocytes Expressing Antibody Coupled T-cell Receptors (CD16V-41BB-CD3ζ), in Combination With Rituximab, in Subjects With Relapsed or Refractory CD20-Positive B-Cell Lymphoma

Cogent Biosciences, Inc.7 sites in 1 country34 target enrollmentAugust 2016

ConditionsLymphoma

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Lymphoma
Sponsor: Cogent Biosciences, Inc.
Enrollment: 34
Locations: 7
Primary Endpoint: Safety as assessed by and adverse events, laboratory assessments and physical examinations
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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

Registry

clinicaltrials.gov

Start Date

August 2016

End Date

February 12, 2020

Last Updated

6 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Cogent Biosciences, Inc.

Responsible Party

Sponsor

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
•Biopsy-confirmed CD20+ expression of the underlying malignancy by immunohistochemical staining or flow cytometry between the most recent dose of an anti-CD20 monoclonal antibody (mAb) and study enrollment
•At least 1 measurable lesion on imaging. Lesions that have been previously irradiated will be considered measurable only if progression has been documented following completion of radiation therapy
•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

Exclusion Criteria

•Known active central nervous system (CNS) involvement by malignancy. Subjects with prior CNS involvement with their lymphoma must have completed effective treatment of their CNS disease at least 3 months prior to enrollment with no evidence of disease clinically and at least stable findings on relevant CNS imaging
•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
•Serum creatinine ≥ 1.5 X age-adjusted upper limits of normal (ULN)
•Pulse oximetry \< 92% on room air