B-cell Non Hodgkin LymphomaPhase 1NCT03778073
Study of Cosibelimab in Subjects With Relapsed or Refractory Lymphoma
A Phase 1 study testing Cosibelimab and Cosibelimab + Ublituximab + Bendamustine combination in people with B-cell Non Hodgkin Lymphoma and Richter's Transformation, run by TG Therapeutics, Inc. at 9 sites in United States.
Trial summary
Phase 1 open label, multi-center, dose-escalation study for individuals with relapsed or refractory B-cell Non Hodgkin's Lymphoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- B-cell Non Hodgkin Lymphoma, Richter's Transformation
- What is being tested?
- Cosibelimab and Cosibelimab + Ublituximab + Bendamustine combination
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 9 sitesUnited States
- Study dates
- 17 Apr 2019to 1 Aug 2022
- 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
- Histologically confirmed relapsed or refractory B-cell non-Hodgkin lymphoma (NHL).
- Measurable disease and adequate organ function as specified in the protocol
Who cannot join
- Prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, or prior therapy with bendamustine.
- Subjects receiving cancer therapy or investigational drug within 21 days of Cycle 1 Day 1.
- Prior autologous stem cell transplant within 3 months
- Active Hepatitis B or Hepatitis C
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
TG Therapeutics Investigational Trial Site
Charlotte, North Carolina, 28262
TG Therapeutics Investigational Trial Site
Fairway, Kansas, 64154
TG Therapeutics Investigational Trial Site
Fayetteville, Arkansas, 72703
TG Therapeutics Investigational Trial Site
Fort Wayne, Indiana, 46804
TG Therapeutics Investigational Trial Site
Huntsville, Alabama, 35805
TG Therapeutics Investigational Trial Site
Louisville, Kentucky, 40207
TG Therapeutics Investigational Trial Site
Peoria, Illinois, 61615
TG Therapeutics Investigational Trial Site
Seattle, Washington, 98108
TG Therapeutics Investigational Trial Site
Tucson, Arizona, 85711
About this study
Official title: A Phase 1 Study of Cosibelimab (TG-1501) in Subjects With Relapsed or Refractory Lymphoma
Phase 1 open label, multi-center, dose-escalation study for individuals with relapsed or refractory B-cell Non Hodgkin's Lymphoma.
Read the detailed description
This study will evaluate the safety profile, pharmacokinetics, and efficacy of single-agent cosibelimab as well as the combination of Cosibelimab + Ublituximab + Bendamustin.
- Being tested
- Cosibelimab, Cosibelimab + Ublituximab + Bendamustine combination
- Keywords
- relapsed or refractory
- Medical subject headings
- Lymphoma, B-Cell, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CosibelimabDrug
Intravenous infusion on Days 1 and 15 of every 28-day cycle or only on Day 1 of every 28-day cycle
Cosibelimab + Ublituximab + Bendamustine combinationDrug
Cosibelimab (Intravenous infusion):
Cycle 1-6 Days 1\&15, Cycles 7-12 Day 1, Cycles 15-24 Day 1 every 3 cycles;
Ublituximab (Intravenous infusion):
Cycles 1-6 Day 1, Cycles 9-24 every 3 Cycles;
Bendamustine (Intravenous infusion):
Cycle 1 Days 2\&3, Cycles 2-6 Days 1\&2.
Cosibelimab + Ublituximab + Bendamustine combinationDrug
Cosibelimab (Intravenous infusion):
Cycle 1-12 Day 1, Cycles 15-24 Day 1 every 3 cycles;
Ublituximab (Intravenous infusion):
Cycles 1-6 Day 1, Cycles 9-24 every 3 Cycles;
Bendamustine (Intravenous infusion):
Cycle 1 Days 2\&3, Cycles 2-6 Days 1\&2.
| Study group | Role | What they receive |
|---|---|---|
| Cohort A | Experimental | Cosibelimab (TG-1501) single-agent Receives: Drug: Cosibelimab |
| Cohort B | Experimental | Cosibelimab + Ublituximab + Bendamustine combination Receives: Drug: Cosibelimab + Ublituximab + Bendamustine combination |
| Cohort C | Experimental | Cosibelimab + Ublituximab + Bendamustine combination Receives: Drug: Cosibelimab + Ublituximab + Bendamustine combination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events That Are Related to Treatment
Number of Participants With Treatment-Related Adverse Events, any potential abnormal laboratory results and any dose-limiting toxicities
Measured: 6 months of therapy
Secondary outcomes (1)
Overall Response Rate
Objective response in subjects treated with interventions
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2018
- Study start17 Apr 2019
- Primary completion3 May 2022
- Study completion1 Aug 2022
Why it stopped: Strategic/Business Decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for B-cell Non Hodgkin LymphomaStudies of the same condition, open and under way.
- More trials run by TG Therapeutics, Inc.The sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- TG Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03778073
- Sponsor's protocol ID
- TG-1501-101
- Status last verified
- Aug 2022
- First submitted
- 11 Dec 2018
- Last updated
- 22 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study of Cosibelimab (TG-1501) in Subjects With Relapsed or Refractory Lymphoma
- ClinicalTrials.gov ID
- NCT03778073
- Acronym / sponsor ID
- TG-1501-101
- Keywords
- relapsed or refractory
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Strategic/Business Decision
- Enrolment
- 18 participants (actual)
- Lead sponsor
- TG Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 17 Apr 2019 (actual)
- Primary completion
- 3 May 2022 (actual)
- Study completion
- 1 Aug 2022 (actual)
- First posted
- 19 Dec 2018 (actual)
- 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.
Phase 1 open label, multi-center, dose-escalation study for individuals with relapsed or refractory B-cell Non Hodgkin's Lymphoma.
Detailed description
This study will evaluate the safety profile, pharmacokinetics, and efficacy of single-agent cosibelimab as well as the combination of Cosibelimab + Ublituximab + Bendamustin.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort A | Experimental | Drug: CosibelimabCosibelimab (TG-1501) single-agent |
| Cohort B | Experimental | Drug: Cosibelimab + Ublituximab + Bendamustine combinationCosibelimab + Ublituximab + Bendamustine combination |
| Cohort C | Experimental | Drug: Cosibelimab + Ublituximab + Bendamustine combinationCosibelimab + Ublituximab + Bendamustine combination |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Histologically confirmed relapsed or refractory B-cell non-Hodgkin lymphoma (NHL).
- Measurable disease and adequate organ function as specified in the protocol
Key exclusion criteria (4 listed)
- Prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, or prior therapy with bendamustine.
- Subjects receiving cancer therapy or investigational drug within 21 days of Cycle 1 Day 1.
- Prior autologous stem cell transplant within 3 months
- Active Hepatitis B or Hepatitis C
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 |
|---|---|---|
| CosibelimabIntravenous infusion on Days 1 and 15 of every 28-day cycle or only on Day 1 of every 28-day cycle | Drug | Cohort A |
| Cosibelimab + Ublituximab + Bendamustine combinationCosibelimab (Intravenous infusion): Cycle 1-6 Days 1\&15, Cycles 7-12 Day 1, Cycles 15-24 Day 1 every 3 cycles; Ublituximab (Intravenous infusion): Cycles 1-6 Day 1, Cycles 9-24 every 3 Cycles; Bendamustine (Intravenous infusion): Cycle 1 Days 2\&3, Cycles 2-6 Days 1\&2. | Drug | Cohort B |
| Cosibelimab + Ublituximab + Bendamustine combinationCosibelimab (Intravenous infusion): Cycle 1-12 Day 1, Cycles 15-24 Day 1 every 3 cycles; Ublituximab (Intravenous infusion): Cycles 1-6 Day 1, Cycles 9-24 every 3 Cycles; Bendamustine (Intravenous infusion): Cycle 1 Days 2\&3, Cycles 2-6 Days 1\&2. | Drug | Cohort C |
Primary outcome
Adverse Events That Are Related to Treatment
Time frame: 6 months of therapy
Number of Participants With Treatment-Related Adverse Events, any potential abnormal laboratory results and any dose-limiting toxicities
1 secondary outcome
Overall Response Rate
Time frame: Up to 12 months
Results and safety
The study was stopped early (reason given: Strategic/Business Decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2022.
Related trials for B-cell Non Hodgkin Lymphoma
Active, not recruitingPhase 1/2
Study of Oral MRT-2359 in Selected Cancer Patients
NSCLC, SCLC
Active, not recruitingPhase 2
A Study of Anakinra to Prevent or Treat Severe Side Effects for Patients Receiving CAR-T Cell Therapy
B Cell ALL, B-Cell Lymphoma
Active, not recruitingEarly Phase 1
Iomab-ACT: A Pilot Study of 131-I Apamistamab Followed by CD19-Targeted CAR T-Cell Therapy for Patients With Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia or Diffuse Large B-Cell Lymphoma
B-ALL, DLBCL
Not yet recruitingPhase 2
The CARDIOPROTECT Trial
Diffuse Large B-cell Lymphoma (DLBCL), Cardiotoxicity
Not yet recruitingPhase 2
QLS4131 Plus Isa-V-CHOP in Newly Diagnosed, HIV-Negative PBL: A Single-Center, Single-Arm, Phase II Study
Plasmablastic Lymphoma
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.
The record lists no contact. Use the official record to reach the sponsor.
9 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 Cosibelimab and Cosibelimab + Ublituximab + Bendamustine combination in people with B-cell Non Hodgkin Lymphoma and Richter's Transformation, run by TG Therapeutics, Inc. at 9 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 2 inclusion and 4 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 22 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 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 (reason given: Strategic/Business Decision). 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?
Adverse Events That Are Related to Treatment (time frame: 6 months of therapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Aug 2022.