Study of ACTR087 in Subjects With Relapsed or Refractory B-cell Lymphoma

Completed · Phase 1

Conditions studied: Lymphoma

In brief

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.

Key facts

Study ID: NCT02776813
Run by: Cogent Biosciences, Inc.
People needed: 34
Starts: 2016-08-01
Expected to finish: 2020-02-12
Last updated by the study team: 2020-03-31

Who can join

Age: 18 and older, up to 75. 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
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
For subjects with MCL (confirmed with cyclin D1 expression or evidence of t(11;14) by cytogenetics, fluorescent in situ hybridization (FISH) or PCR): relapsed or refractory disease after at least 1 prior regimen with chemo-immunotherapy (prior auto-HSCT is allowable)
Karnofsky performance scale ≥ 60%
Life expectancy of at least 6 months
ANC > 1000/µL
Platelet count > 50,000/µL
For women of childbearing potential (defined as physiologically capable of becoming pregnant), agreement to use of highly effective contraception for at least 1 year following ACTR087 infusion. For men with partners of childbearing potential, agreement to use effective barrier contraception for at least 1 year following ACTR087 infusion

You may not qualify if…

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
Direct bilirubin ≥ 3.0 mg/dL (50 mmol/L)
Alanine transaminase (ALT) ≥ 3 times the ULN, unless determined to be directly due to lymphoma.
Aspartate transaminase (AST) ≥ 3 times the ULN, unless determined to be directly due to lymphoma
Class III or IV heart failure as defined by the New York Heart Association (NYHA), history of cardiac angioplasty or stenting, documented myocardial infarction or unstable angina within 6 months prior to enrollment, cardiac ejection fraction of < 45%, or other clinically significant cardiac disease
Clinical history of, prior diagnosis of, or overt evidence of autoimmune disease, regardless of severity
Clinically significant active infection, in the judgment of the investigator
Pregnancy (negative serum pregnancy test to be obtained within 6 days prior to enrollment for subjects of childbearing potential)
Breastfeeding
Primary immunodeficiency
Seropositive for Human Immunodeficiency Virus (HIV) 1 or HIV 2, or positive hepatitis B surface antigen (HBsAg) or hepatitis C antibody
Will need or has needed active treatment of a second malignancy within the prior 3 years before enrollment, other than FL, non-melanoma skin cancers, localized prostate cancer treated with curative intent, or cervical carcinoma in situ
Is unable to receive any of the agents used in this study due a history of severe immediate hypersensitivity reaction (e.g. hypersensitivity to dimethyl sulfoxide (DMSO))
History of prior allogeneic HSCT
History of Richter's transformation from CLL
Prior infusion of a genetically modified therapy

Where it is running

Banner MD Anderson Cancer Center — Gilbert, Arizona, United States
Yale University — New Haven, Connecticut, United States
Loyola University Chicago — Maywood, Illinois, United States
Indiana Bone and Marrow Transplantation — Indianapolis, Indiana, United States
Massachusetts General Hospital — Boston, Massachusetts, United States
Duke University Medical Center — Durham, North Carolina, United States
Ohio State University — Columbus, Ohio, United States

Full record on ClinicalTrials.gov

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