Study of ACTR707 in Combination With Rituximab in Subjects With Relapsed or Refractory B Cell Lymphoma
Study Details
Study Description
Brief Summary
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.
Condition or Disease | Intervention/Treatment | Phase |
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Phase 1 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: ACTR707 in combination with rituximab
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Biological: ACTR707
autologous T cell product
Biological: rituximab
CD20-directed cytolytic antibody
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Outcome Measures
Primary Outcome Measures
- Safety as assessed by dose limiting toxicities (DLTs) [28 days]
Dose-limiting toxicities, MTD, incidence and severity of AEs and clinically significant abnormalities of laboratory values
- Determination of maximum tolerated dose and proposed recommended Phase 2 dose [24 weeks]
Secondary Outcome Measures
- Anti-lymphoma activity as measured by overall response rate [24 weeks]
- Anti-lymphoma activity as measured by duration of response [24 weeks]
- Anti-lymphoma activity as measured by progression-free survival [24 weeks]
- Anti-lymphoma activity as measure by overall survival [24 weeks]
- Assessment of persistence of ACTR707 as measured by flow cytometry and qPCR [24 weeks]
- Assessment of ACTR707 phenotype and function as measured by flow cytometry [24 weeks]
- Assessment of inflammatory markers and cytokines/chemokines [24 weeks]
Cytokines and Inflammatory markers
- Rituximab PK [24 weeks]
Rituximab plasma concentration
Eligibility Criteria
Criteria
Inclusion Criteria:
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signed written informed consent obtained prior to study procedures
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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).
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biopsy-confirmed CD20+ expression of the underlying malignancy with disease progression following immediate prior therapy
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at least 1 measurable lesion on imaging.
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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:
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biopsy-proven refractory disease after frontline chemo-immunotherapy
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relapse within 1 year from frontline chemo-immunotherapy and ineligible for autologous hematopoietic stem cell transplant (auto-HSCT)
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for subjects with DLBCL, PMBCL, and Gr3b-FL: relapsed or refractory disease following at least 2 prior regimens or following an auto-HSCT
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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
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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)
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ECOG 0 or 1
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life expectancy of at least 6 months
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platelet count greater than 50,000/µL
Exclusion Criteria:
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known active central nervous system (CNS) involvement by malignancy.
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prior treatment as follows:
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alemtuzumab within 6 months of enrollment
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fludarabine, cladribine, or clofarabine within 3 months of enrollment
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external beam radiation within 2 weeks of enrollment
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mAb (including rituximab) within 2 weeks of enrollment
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other lymphotoxic chemotherapy (including steroids except as below) within 2 weeks of enrollment
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experimental agents within 3 half-lives prior to enrollment, unless progression is documented on therapy
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clinically significant cardiac disease
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clinically significant active infection
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clinically significant CNS disorder
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clinical history, prior diagnosis, or overt evidence of autoimmune disease
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known bone marrow involvement due to underlying malignant disease, in dose-escalation phase only
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Banner MD Anderson Cancer Center | Gilbert | Arizona | United States | 85234 |
2 | Yale University | New Haven | Connecticut | United States | 06520 |
3 | Emory University, Winship Cancer Institute | Atlanta | Georgia | United States | 30322 |
4 | Loyola University | Maywood | Illinois | United States | 60153 |
5 | Indiana Bone and Marrow Transplantation | Indianapolis | Indiana | United States | 46327 |
6 | University of Maryland | Baltimore | Maryland | United States | 21201 |
7 | University of Minnesota | Minneapolis | Minnesota | United States | 55455 |
8 | Ohio State University | Columbus | Ohio | United States | 43210 |
9 | Tennessee Oncology - Nashville | Nashville | Tennessee | United States | 37203 |
10 | The University of Texas MD Anderson Cancer Center | Houston | Texas | United States | 77030 |
11 | Medical College of Wisconsin | Milwaukee | Wisconsin | United States | 53226 |
Sponsors and Collaborators
- Cogent Biosciences, Inc.
Investigators
- Study Director: Jessica Sachs, MD, Cogent Biosciences, Inc.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ATTCK-20-03