Non-Hodgkin LymphomaPhase 1NCT02702141
A Safety Study of SGN-CD19B in Patients With B-cell Non-Hodgkin Lymphoma
A Phase 1 study testing SGN-CD19B in people with Non-Hodgkin Lymphoma and DLBCL, run by Seagen Inc. at 16 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Hodgkin Lymphoma, DLBCL, Diffuse Large B-cell Lymphoma
- What is being tested?
- SGN-CD19B
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 16 sitesUnited States
- Study dates
- Feb 2016to 10 Jul 2018
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
United States16 sites
University of Alabama at Birmingham
Birmingham, Alabama, 35294
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
Medical University of South Carolina/Hollings Cancer Center
Charleston, South Carolina, 29425
Cleveland Clinic, The
Cleveland, Ohio, 44195
City of Hope National Medical Center
Duarte, California, 91010-3000
Hackensack University Medical Center
Hackensack, New Jersey, 07601
Mayo Clinic Florida
Jacksonville, Florida, 32224
Carbone Cancer Center / University of Wisconsin
Madison, Wisconsin, United States
Cardinal Bernardin Cancer Center / Loyola University Medical Center
Maywood, Illinois, 60153
New York University (NYU) Cancer Institute
New York, New York, 10016
Memorial Sloan Kettering Cancer Center
New York, New York, 10021
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
Mayo Clinic Minnesota
Rochester, Minnesota, 55905
University of Utah
Salt Lake City, Utah, 84112
Seattle Cancer Care Alliance / University of Washington
Seattle, Washington, 98109-1023
About this study
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
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.
Read the 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.
- Being tested
- SGN-CD19B
- Keywords
- Non-hodgkin lymphoma, Antibody-drug conjugate, CD19, Diffuse large B-cell lymphoma, DLBCL, Grade 3 follicular lymphoma
- Medical subject headings
- Lymphoma, Non-Hodgkin, Lymphoma, Large B-Cell, Diffuse, Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SGN-CD19BDrug
Given intravenously Day 1 of 28-day or 42-day cycles
| Study group | Role | What they receive |
|---|---|---|
| SGN-CD19B | Experimental | Not described Receives: Drug: SGN-CD19B |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events
Measured: Through 1 month following last dose
Incidence of laboratory abnormalities
Measured: Through 1 month following last dose
Secondary outcomes (5)
Blood concentrations of SGN-CD19B
Measured: Through 3 weeks after dosing
Incidence of antitherapeutic antibodies
Measured: Through 1 month following last dose
Objective response rate
Measured: Through 1 month following last dose
Rate of response
Measured: Through 1 month following last dose
Progression-free survival
Measured: Up to approximately 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2016 (estimated)
- Study startFeb 2016
- Primary completion10 Jul 2018
- Study completion10 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non-Hodgkin LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seagen Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Juan Pinelli, PA-C, MMSc, Study director, Seagen Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02702141
- Sponsor's protocol ID
- SGN19B-001
- Status last verified
- Aug 2018
- First submitted
- 25 Feb 2016
- Last updated
- 13 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Ryan MC, Palanca-Wessels MC, Schimpf B, Gordon KA, Kostner H, Meyer B, Yu C, Van Epps HA, Benjamin D. Therapeutic potential of SGN-CD19B, a PBD-based anti-CD19 drug conjugate, for treatment of B-cell malignancies. Blood. 2017 Nov 2;130(18):2018-2026. doi: 10.1182/blood-2017-04-779389. Epub 2017 Sep 13.
PubMed 28903943
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02702141
- Acronym / sponsor ID
- SGN19B-001
- Keywords
- Non-hodgkin lymphoma, Antibody-drug conjugate, CD19, Diffuse large B-cell lymphoma, DLBCL, Grade 3 follicular lymphoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Seagen Inc.Industry (pharma, biotech, devices)
- Study start
- Feb 2016 (actual)
- Primary completion
- 10 Jul 2018 (actual)
- Study completion
- 10 Jul 2018 (actual)
- First posted
- 8 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SGN-CD19B | Experimental | Drug: SGN-CD19B |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SGN-CD19BGiven intravenously Day 1 of 28-day or 42-day cycles | Drug | SGN-CD19B |
Primary outcome
Incidence of adverse events
Time frame: Through 1 month following last dose
Incidence of laboratory abnormalities
Time frame: Through 1 month following last dose
5 secondary outcomes
Blood concentrations of SGN-CD19B
Time frame: Through 3 weeks after dosing
Incidence of antitherapeutic antibodies
Time frame: Through 1 month following last dose
Objective response rate
Time frame: Through 1 month following last dose
Rate of response
Time frame: Through 1 month following last dose
Progression-free survival
Time frame: Up to approximately 3 years
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2018.
- Derived from this study: PubMed 28903943Ryan MC, Palanca-Wessels MC, Schimpf B, Gordon KA, Kostner H, Meyer B, Yu C, Van Epps HA, Benjamin D. Therapeutic potential of SGN-CD19B, a PBD-based anti-CD19 drug conjugate, for treatment of B-cell malignancies. Blood. 2017 Nov 2;130(18):2018-2026. doi: 10.1182/blood-2017-04-779389. Epub 2017 Sep 13.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Juan Pinelli, PA-C, MMSc study director
Seagen Inc.
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SGN-CD19B in people with Non-Hodgkin Lymphoma and DLBCL, run by Seagen Inc. at 16 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 13 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of adverse events (time frame: Through 1 month following last dose). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02702141, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2018.