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



Status:Recruiting
Conditions:Lymphoma
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - 80
Updated:12/22/2018
Start Date:October 4, 2017
End Date:March 2021
Contact:Francis Payumo
Email:francis.payumo@unumrx.com
Phone:530-868-6471

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Phase 1 Study of ACTR707, an Autologous T Cell Product, in Combination With Rituximab, in Subjects With Relapsed or Refractory CD20+ B Cell Lymphoma

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.


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
We found this trial at
6
sites
281 W. Lane Ave
Columbus, Ohio 43210
(614) 292-6446
Ohio State University The Ohio State University’s main Columbus campus is one of America’s largest...
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Minneapolis, Minnesota 55455
(612) 625-5000
Principal Investigator: Veronika Bachanova, MD
Phone: 612-625-5469
Univ of Minnesota With a flagship campus in the heart of the Twin Cities, and...
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Atlanta, Georgia 30322
Phone: 404-778-4400
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Atlanta, GA
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1515 Holcombe Blvd
Houston, Texas 77030
 713-792-2121
Phone: 713-794-1062
University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
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Indianapolis, Indiana 46237
Phone: 317-528-5500
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Indianapolis, IN
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Nashville, Tennessee 37203
Principal Investigator: Ian W Flinn, MD, PhD
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Nashville, TN
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