CLLPhase 1NCT04806035
Study of TG-1801 Alone or in Combination With Ublituximab in Subjects With B-Cell Lymphoma or Chronic Lymphocytic Leukemia
A Phase 1 study testing TG-1801 and Ublituximab in people with CLL and SLL, run by TG Therapeutics, Inc. at 5 sites in United States.
Trial summary
The primary objective of this study is to determine the recommended phase 2 dose (RP2D) and characterize the safety profile of TG-1801. As per protocol v3.0, ublituximab will be discontinued. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- CLL, SLL, Richter's Transformation
- What is being tested?
- TG-1801 and Ublituximab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 5 sitesUnited States
- Study dates
- 28 Apr 2021to 12 Jun 2024
- 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
- B-cell non-Hodgkin lymphoma (NHL) including Richter's Transformation (RT) and transformed follicular lymphoma (FL), that warrants systemic therapy
- Chronic Lymphocytic Leukemia (CLL), that warrants systemic therapy as defined by International Workshop on Chronic Lymphocytic Leukemia (iwCLL) (Hallek 2018)
- Treatment Status:
- NHL subjects: relapsed to or refractory after at least two prior standard systemic therapies (excluding antibiotics)
- RT subjects: relapsed or refractory after at least two prior lines of therapy for CLL/ Small lymphocytic lymphoma (SLL) or RT
- CLL subjects: relapsed to or refractory after at least two prior standard therapies
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- Measurable disease defined as:
- NHL (including SLL): at least 1 measurable disease lesion > 1.5 centimeters (cm)
- CLL: at least 1 measurable disease lesion
Who cannot join
- Prior therapy with any agent blocking the CD47/SIRPα pathway or any previous CD19 targeting therapy,
- Subjects receiving cancer therapy (i.e. chemotherapy, radiation therapy, immunotherapy, biologic therapy, hormonal therapy, surgery and/or tumor embolization) or any investigational drug within 21 days of Cycle 1 Day 1.
- Prior autologous stem cell transplant (SCT) within 6 months.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
TG Therapeutics Investigational Trial Site
Chattanooga, Tennessee, 37404
TG Therapeutics Investigational Trial Site
Fayetteville, Arkansas, 72703
TG Therapeutics Investigational Trial Site
Hackensack, New Jersey, 07601
TG Therapeutics Investigational Trial Site
Houston, Texas, 77030
TG Therapeutics Investigational Trial Site
Nashville, Tennessee, 37203
About this study
Official title: A Phase 1b Multi-cohort Study of TG-1801 Alone or in Combination With Ublituximab in Subjects With B-Cell Lymphoma or Chronic Lymphocytic Leukemia
The primary objective of this study is to determine the recommended phase 2 dose (RP2D) and characterize the safety profile of TG-1801. As per protocol v3.0, ublituximab will be discontinued.
- Conditions
- CLL, SLL, Richter's Transformation, Indolent Lymphoma, Follicular Lymphoma, Marginal Zone Lymphoma
- Being tested
- TG-1801, Ublituximab
- Medical subject headings
- Lymphoma, Follicular, Lymphoma, B-Cell, Marginal Zone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TG-1801Biological
Also called NI-1701
It is a bispecific, first-in-class, CD47 and CD19 antibody
UblituximabBiological
Also called TG-1101, LFB-R603
recombinant chimeric anti-CD20 monoclonal antibody, available in 25 mg/mL administered as an IV infusion once every 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Cohort A: TG-1801 | Experimental | TG-1801 Single Agent
As per protocol v3.0, Cohort A is no longer enrolling. Receives: Biological: TG-1801 |
| Cohort B: TG-1801 | Experimental | TG-1801 Single Agent, escalating doses Receives: Biological: TG-1801 |
| Cohort C: TG-1801 + Ublituximab | Experimental | TG-1801 in combination with ublituximab
As per protocol v3.0, ublituximab will be discontinued and the Cohort C is no longer enrolling. Receives: Biological: TG-1801; Biological: Ublituximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
RP2D
To determine the recommended Phase 2 dose (RP2D)
Measured: Up to 24 months
Secondary outcomes (1)
Overall Response Rate
To evaluate the overall response rate (ORR) of TG-1801
Measured: Up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2021
- Study start28 Apr 2021
- Primary completion12 Jun 2024
- Study completion12 Jun 2024
Why it stopped: Strategic/Business Decision
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 CLLStudies 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
- 21 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
- NCT04806035
- Sponsor's protocol ID
- TG-1801-102
- Status last verified
- Jul 2024
- First submitted
- 5 Mar 2021
- Last updated
- 31 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Chauchet X, Cons L, Chatel L, Daubeuf B, Didelot G, Moine V, Chollet D, Malinge P, Pontini G, Masternak K, Ferlin W, Buatois V, Shang L. CD47xCD19 bispecific antibody triggers recruitment and activation of innate immune effector cells in a B-cell lymphoma xenograft model. Exp Hematol Oncol. 2022 May 10;11(1):26. doi: 10.1186/s40164-022-00279-w.
PubMed 35538512
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b Multi-cohort Study of TG-1801 Alone or in Combination With Ublituximab in Subjects With B-Cell Lymphoma or Chronic Lymphocytic Leukemia
- ClinicalTrials.gov ID
- NCT04806035
- Acronym / sponsor ID
- TG-1801-102
- Conditions
- CLL, SLL, Richter's Transformation, Indolent Lymphoma, Follicular Lymphoma, Marginal Zone Lymphoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Strategic/Business Decision
- Enrolment
- 21 participants (actual)
- Lead sponsor
- TG Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 28 Apr 2021 (actual)
- Primary completion
- 12 Jun 2024 (actual)
- Study completion
- 12 Jun 2024 (actual)
- First posted
- 19 Mar 2021 (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.
The primary objective of this study is to determine the recommended phase 2 dose (RP2D) and characterize the safety profile of TG-1801. As per protocol v3.0, ublituximab will be discontinued.
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: TG-1801 | Experimental | Biological: TG-1801TG-1801 Single Agent As per protocol v3.0, Cohort A is no longer enrolling. |
| Cohort B: TG-1801 | Experimental | Biological: TG-1801TG-1801 Single Agent, escalating doses |
| Cohort C: TG-1801 + Ublituximab | Experimental | Biological: TG-1801, Biological: UblituximabTG-1801 in combination with ublituximab As per protocol v3.0, ublituximab will be discontinued and the Cohort C is no longer enrolling. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- B-cell non-Hodgkin lymphoma (NHL) including Richter's Transformation (RT) and transformed follicular lymphoma (FL), that warrants systemic therapy
- Chronic Lymphocytic Leukemia (CLL), that warrants systemic therapy as defined by International Workshop on Chronic Lymphocytic Leukemia (iwCLL) (Hallek 2018)
- Treatment Status:
- Measurable disease defined as:
Key exclusion criteria (3 listed)
- Prior therapy with any agent blocking the CD47/SIRPα pathway or any previous CD19 targeting therapy,
- Subjects receiving cancer therapy (i.e. chemotherapy, radiation therapy, immunotherapy, biologic therapy, hormonal therapy, surgery and/or tumor embolization) or any investigational drug within 21 days of Cycle 1 Day 1.
- Prior autologous stem cell transplant (SCT) within 6 months.
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 |
|---|---|---|
| TG-1801Also: NI-1701It is a bispecific, first-in-class, CD47 and CD19 antibody | Biological | Cohort A: TG-1801, Cohort B: TG-1801, Cohort C: TG-1801 + Ublituximab |
| UblituximabAlso: TG-1101, LFB-R603recombinant chimeric anti-CD20 monoclonal antibody, available in 25 mg/mL administered as an IV infusion once every 4 weeks | Biological | Cohort C: TG-1801 + Ublituximab |
Primary outcome
RP2D
Time frame: Up to 24 months
To determine the recommended Phase 2 dose (RP2D)
1 secondary outcome
Overall Response Rate
Time frame: Up to 24 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 31 Jul 2024.
- Derived from this study: PubMed 35538512Chauchet X, Cons L, Chatel L, Daubeuf B, Didelot G, Moine V, Chollet D, Malinge P, Pontini G, Masternak K, Ferlin W, Buatois V, Shang L. CD47xCD19 bispecific antibody triggers recruitment and activation of innate immune effector cells in a B-cell lymphoma xenograft model. Exp Hematol Oncol. 2022 May 10;11(1):26. doi: 10.1186/s40164-022-00279-w.
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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.
The record lists no contact. Use the official record to reach the sponsor.
5 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 TG-1801 and Ublituximab in people with CLL and SLL, run by TG Therapeutics, Inc. at 5 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 9 inclusion and 3 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 31 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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?
RP2D (time frame: Up to 24 months). 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 NCT04806035, 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 31 Jul 2024.