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

Therapuetic Areas:Oncology
Age Range:18 - 75
Start Date:August 2016
End Date:March 2020
Contact:Michael O'Meara
Phone:(617) 453 8344

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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

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.

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



- Gr3b-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

- 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

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

- Direct bilirubin ≥ 3.0 mg/dL (50 mmol/L)

- Alanine transaminase (ALT) ≥ 3 times the ULN, unless determined to be directly due to

- 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

- History of prior allogeneic HSCT

- History of Richter's transformation from CLL

- Prior infusion of a genetically modified therapy
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