Description:
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.
Title
- Brief Title: Study of ACTR707 in Combination With Rituximab in Subjects With Relapsed or Refractory B Cell Lymphoma
- Official Title: Phase 1 Study of ACTR707, an Autologous T Cell Product, in Combination With Rituximab, in Subjects With Relapsed or Refractory CD20+ B Cell Lymphoma
Clinical Trial IDs
- ORG STUDY ID:
ATTCK-20-03
- NCT ID:
NCT03189836
Conditions
Interventions
Drug | Synonyms | Arms |
---|
ACTR707 | | ACTR707 in combination with rituximab |
rituximab | | ACTR707 in combination with rituximab |
Purpose
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 Arms
Name | Type | Description | Interventions |
---|
ACTR707 in combination with rituximab | Experimental | | |
Eligibility Criteria
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
Maximum Eligible Age: | 80 Years |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Safety as assessed by dose limiting toxicities (DLTs) |
Time Frame: | 28 days |
Safety Issue: | |
Description: | Dose-limiting toxicities, MTD, incidence and severity of AEs and clinically significant abnormalities of laboratory values |
Secondary Outcome Measures
Measure: | Anti-lymphoma activity as measured by overall response rate |
Time Frame: | 24 weeks |
Safety Issue: | |
Description: | |
Measure: | Anti-lymphoma activity as measured by duration of response |
Time Frame: | 24 weeks |
Safety Issue: | |
Description: | |
Measure: | Anti-lymphoma activity as measured by progression-free survival |
Time Frame: | 24 weeks |
Safety Issue: | |
Description: | |
Measure: | Anti-lymphoma activity as measure by overall survival |
Time Frame: | 24 weeks |
Safety Issue: | |
Description: | |
Measure: | Assessment of persistence of ACTR707 as measured by flow cytometry and qPCR |
Time Frame: | 24 weeks |
Safety Issue: | |
Description: | |
Measure: | Assessment of ACTR707 phenotype and function as measured by flow cytometry |
Time Frame: | 24 weeks |
Safety Issue: | |
Description: | |
Measure: | Assessment of inflammatory markers and cytokines/chemokines |
Time Frame: | 24 weeks |
Safety Issue: | |
Description: | Cytokines and Inflammatory markers |
Measure: | Rituximab PK |
Time Frame: | 24 weeks |
Safety Issue: | |
Description: | Rituximab plasma concentration |
Details
Phase: | Phase 1 |
Primary Purpose: | Interventional |
Overall Status: | Active, not recruiting |
Lead Sponsor: | Cogent Biosciences, Inc. |
Trial Keywords
- CD20+
- B cell
- ACTR
- ACTR707
- relapsed
- refractory
- T cell
- T cell product
- adoptive T cells
- gene therapy
Last Updated
March 30, 2020