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

Sponsor
Cogent Biosciences, Inc. (Industry)
Overall Status
Terminated
CT.gov ID
NCT03189836
Collaborator
(none)
26
11
1
35.6
2.4
0.1

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
  • Biological: ACTR707
  • Biological: rituximab
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
26 participants
Allocation:
N/A
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
Actual Study Start Date :
Oct 4, 2017
Actual Primary Completion Date :
Sep 21, 2020
Actual Study Completion Date :
Sep 21, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: ACTR707 in combination with rituximab

Biological: ACTR707
autologous T cell product

Biological: rituximab
CD20-directed cytolytic antibody

Outcome Measures

Primary Outcome Measures

  1. 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

  2. Determination of maximum tolerated dose and proposed recommended Phase 2 dose [24 weeks]

Secondary Outcome Measures

  1. Anti-lymphoma activity as measured by overall response rate [24 weeks]

  2. Anti-lymphoma activity as measured by duration of response [24 weeks]

  3. Anti-lymphoma activity as measured by progression-free survival [24 weeks]

  4. Anti-lymphoma activity as measure by overall survival [24 weeks]

  5. Assessment of persistence of ACTR707 as measured by flow cytometry and qPCR [24 weeks]

  6. Assessment of ACTR707 phenotype and function as measured by flow cytometry [24 weeks]

  7. Assessment of inflammatory markers and cytokines/chemokines [24 weeks]

    Cytokines and Inflammatory markers

  8. Rituximab PK [24 weeks]

    Rituximab plasma concentration

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
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.
Responsible Party:
Cogent Biosciences, Inc.
ClinicalTrials.gov Identifier:
NCT03189836
Other Study ID Numbers:
  • ATTCK-20-03
First Posted:
Jun 16, 2017
Last Update Posted:
Oct 11, 2021
Last Verified:
Oct 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
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 Cogent Biosciences, Inc.
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 11, 2021