A Safety Study of SGN-CD19B in Patients With B-cell Non-Hodgkin Lymphoma

Sponsor
Seagen Inc. (Industry)
Overall Status
Terminated
CT.gov ID
NCT02702141
Collaborator
(none)
44
16
1
29.2
2.8
0.1

Study Details

Study Description

Brief Summary

The study will examine the safety profile of SGN-CD19B administered as a single agent. The main purpose of the study is to estimate the highest dose that does not cause unacceptable side effects of SGN-CD19B in patients with relapsed or refractory aggressive B-cell non-Hodgkin lymphoma (NHL) subtypes of diffuse large B-cell lymphoma (DLBCL) and Grade 3 follicular lymphoma (FL3). Additionally, the pharmacokinetic profile and antitumor activity of SGN-CD19B will be assessed.

Condition or Disease Intervention/Treatment Phase
Phase 1

Detailed Description

SGN-CD19B will be given to patients at increasing doses every 28 days (or on an alternative dosing schedule of every 42 days).

Individual expansion cohorts of up to approximately 20 patients will be opened at dose levels selected by the Safety Monitoring Committee based on the aggregate known safety and activity data to further define the safety and antitumor activity in refractory and relapsed disease subgroups.

Study Design

Study Type:
Interventional
Actual Enrollment :
44 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase 1, Open-label, Dose-escalation Study of SGN-CD19B in Patients With Relapsed or Refractory Aggressive B-cell Non-Hodgkin Lymphoma
Actual Study Start Date :
Feb 1, 2016
Actual Primary Completion Date :
Jul 10, 2018
Actual Study Completion Date :
Jul 10, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: SGN-CD19B

Drug: SGN-CD19B
Given intravenously Day 1 of 28-day or 42-day cycles

Outcome Measures

Primary Outcome Measures

  1. Incidence of adverse events [Through 1 month following last dose]

  2. Incidence of laboratory abnormalities [Through 1 month following last dose]

Secondary Outcome Measures

  1. Blood concentrations of SGN-CD19B [Through 3 weeks after dosing]

  2. Incidence of antitherapeutic antibodies [Through 1 month following last dose]

  3. Objective response rate [Through 1 month following last dose]

  4. Rate of response [Through 1 month following last dose]

  5. Progression-free survival [Up to approximately 3 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Relapsed, refractory, or progressive disease following at least 2 prior systemic therapies

  • Measurable disease

  • Eastern Cooperative Oncology Group status of 0 or 1

  • Adequate baseline renal and hepatic function

Exclusion Criteria:
  • Prior treatment with CD19 directed agents unless CD19 expression is confirmed after completion of CD19-directed treatment

  • Known HIV, active hepatitis B or active hepatitis C infection

  • Prior allogeneic stem cell transplant

  • Inadequate lung function

  • Anticancer treatment within 4 weeks of study drug or 2 weeks if patient experienced disease progression on prior treatment

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Alabama at Birmingham Birmingham Alabama United States 35294
2 City of Hope National Medical Center Duarte California United States 91010-3000
3 Mayo Clinic Florida Jacksonville Florida United States 32224
4 Cardinal Bernardin Cancer Center / Loyola University Medical Center Maywood Illinois United States 60153
5 Beth Israel Deaconess Medical Center Boston Massachusetts United States 02215
6 Dana Farber Cancer Institute Boston Massachusetts United States 02215
7 Mayo Clinic Minnesota Rochester Minnesota United States 55905
8 Hackensack University Medical Center Hackensack New Jersey United States 07601
9 New York University (NYU) Cancer Institute New York New York United States 10016
10 Memorial Sloan Kettering Cancer Center New York New York United States 10021
11 Cleveland Clinic, The Cleveland Ohio United States 44195
12 Thomas Jefferson University Philadelphia Pennsylvania United States 19107
13 Medical University of South Carolina/Hollings Cancer Center Charleston South Carolina United States 29425
14 University of Utah Salt Lake City Utah United States 84112
15 Seattle Cancer Care Alliance / University of Washington Seattle Washington United States 98109-1023
16 Carbone Cancer Center / University of Wisconsin Madison Wisconsin United States United States

Sponsors and Collaborators

  • Seagen Inc.

Investigators

  • Study Director: Juan Pinelli, PA-C, MMSc, Seagen Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Seagen Inc.
ClinicalTrials.gov Identifier:
NCT02702141
Other Study ID Numbers:
  • SGN19B-001
First Posted:
Mar 8, 2016
Last Update Posted:
Aug 13, 2018
Last Verified:
Aug 1, 2018

Study Results

No Results Posted as of Aug 13, 2018