Study Stopped
Business decision
Study of ACTR707 in Combination With Rituximab in Subjects With Relapsed or Refractory B Cell Lymphoma
Phase 1 Study of ACTR707, an Autologous T Cell Product, in Combination With Rituximab, in Subjects With Relapsed or Refractory CD20+ B Cell Lymphoma
1 other identifier
interventional
26
1 country
11
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 lymphoma
Started Oct 2017
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 12, 2017
CompletedFirst Posted
Study publicly available on registry
June 16, 2017
CompletedStudy Start
First participant enrolled
October 4, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 21, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
September 21, 2020
CompletedOctober 11, 2021
October 1, 2021
3 years
June 12, 2017
October 4, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Safety as assessed by dose limiting toxicities (DLTs)
Dose-limiting toxicities, MTD, incidence and severity of AEs and clinically significant abnormalities of laboratory values
28 days
Determination of maximum tolerated dose and proposed recommended Phase 2 dose
24 weeks
Secondary Outcomes (8)
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
- +3 more secondary outcomes
Study Arms (1)
ACTR707 in combination with rituximab
EXPERIMENTALInterventions
Eligibility Criteria
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 (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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (11)
Banner MD Anderson Cancer Center
Gilbert, Arizona, 85234, United States
Yale University
New Haven, Connecticut, 06520, United States
Emory University, Winship Cancer Institute
Atlanta, Georgia, 30322, United States
Loyola University
Maywood, Illinois, 60153, United States
Indiana Bone and Marrow Transplantation
Indianapolis, Indiana, 46327, United States
University of Maryland
Baltimore, Maryland, 21201, United States
University of Minnesota
Minneapolis, Minnesota, 55455, United States
Ohio State University
Columbus, Ohio, 43210, United States
Tennessee Oncology - Nashville
Nashville, Tennessee, 37203, United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
Related Publications (1)
Ernst M, Oeser A, Besiroglu B, Caro-Valenzuela J, Abd El Aziz M, Monsef I, Borchmann P, Estcourt LJ, Skoetz N, Goldkuhle M. Chimeric antigen receptor (CAR) T-cell therapy for people with relapsed or refractory diffuse large B-cell lymphoma. Cochrane Database Syst Rev. 2021 Sep 13;9(9):CD013365. doi: 10.1002/14651858.CD013365.pub2.
PMID: 34515338DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Jessica Sachs, MD
Cogent Biosciences, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 12, 2017
First Posted
June 16, 2017
Study Start
October 4, 2017
Primary Completion
September 21, 2020
Study Completion
September 21, 2020
Last Updated
October 11, 2021
Record last verified: 2021-10
Data Sharing
- IPD Sharing
- Will not share