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

This study is not yet open for participant recruitment.
See Contacts and Locations
Verified June 2017 by Unum Therapeutics Inc.
Sponsor:
Information provided by (Responsible Party):
Unum Therapeutics Inc.
ClinicalTrials.gov Identifier:
NCT03189836
First received: June 12, 2017
Last updated: June 14, 2017
Last verified: June 2017
  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.

Condition Intervention Phase
Lymphoma Biological: ACTR707 Biological: rituximab Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Unum Therapeutics Inc.:

Primary Outcome Measures:
  • Safety as assessed by dose limiting toxicities (DLTs) [ Time Frame: 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 [ Time Frame: 24 weeks ]

Secondary Outcome Measures:
  • Anti-lymphoma activity as measured by overall response rate [ Time Frame: 24 weeks ]
  • Anti-lymphoma activity as measured by duration of response [ Time Frame: 24 weeks ]
  • Anti-lymphoma activity as measured by progression-free survival [ Time Frame: 24 weeks ]
  • Anti-lymphoma activity as measure by overall survival [ Time Frame: 24 weeks ]
  • Assessment of persistence of ACTR707 as measured by flow cytometry and qPCR [ Time Frame: 24 weeks ]
  • Assessment of ACTR707 phenotype and function as measured by flow cytometry [ Time Frame: 24 weeks ]
  • Assessment of inflammatory markers and cytokines/chemokines [ Time Frame: 24 weeks ]
    Cytokines and Inflammatory markers

  • Rituximab PK [ Time Frame: 24 weeks ]
    Rituximab plasma concentration


Estimated Enrollment: 40
Anticipated Study Start Date: July 2017
Estimated Study Completion Date: March 2021
Estimated Primary Completion Date: January 2021 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ACTR707 in combination with rituximab Biological: ACTR707
autologous T cell product
Biological: rituximab
CD20-directed cytolytic antibody

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03189836

Contacts
Contact: Francis Payumo 530-868-6471 francis.payumo@unumrx.com
Contact: Michael Vasconcelles, MD 857-209-4741 michael.vasconcelles@unumrx.com

Sponsors and Collaborators
Unum Therapeutics Inc.
Investigators
Study Director: Michael Vasconcelles, MD Unum Therapeutics Inc.
  More Information

Responsible Party: Unum Therapeutics Inc.
ClinicalTrials.gov Identifier: NCT03189836     History of Changes
Other Study ID Numbers: ATTCK-20-03
Study First Received: June 12, 2017
Last Updated: June 14, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Unum Therapeutics Inc.:
CD20+
B cell
ACTR
ACTR707
relapsed
refractory
T cell
T cell product
adoptive T cells
gene therapy

Additional relevant MeSH terms:
Lymphoma
Lymphoma, B-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Rituximab
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents

ClinicalTrials.gov processed this record on September 21, 2017