Multi CenterPhase 2NCT07917832
Smart 3: A Multi-Center Phase 2 Trial Of Golcadomide, Glofitamab And Polatuzumab Vedotin (G2P) For Patients With Newly Diagnosed Large B-Cell Lymphoma
A Phase 2 study testing golcadomide, Obinutuzumab and Polatuzumab in people with Multi Center and Phase 2, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
To learn if the combination of golcadomide, obinutuzumab, glofitamab, and polatuzumab vedotin in LBCL participants can help to control the disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multi Center, Phase 2, Golcadomide
- What is being tested?
- golcadomide, Obinutuzumab and Polatuzumab
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Apr 2027to 30 Jun 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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
None listed.
Who cannot join
- Subjects will be ineligible for this study if they meet any of following criteria:
- Central nervous system involvement of lymphoma
- > Suspicious cases at the time of diagnosis should be evaluated with brain MRI with or without lumbar puncture
- Any prior history of other malignancy besides B-NHL, unless the Participant has been free of disease for ≥ 2 year and felt to be at low risk for recurrence by the treating physician, except:
- Adequately treated localized skin cancer without evidence of disease
- Adequately treated cervical carcinoma in situ without evidence of disease
Show all 31Show fewer
- Adequately treated localized breast cancer without evidence of disease
- Adequately treated localized prostate cancer without evidence of disease
- Any life-threatening illness, medical condition, or organ system dysfunction which, in the investigator's opinion, could compromise the subject's safety, interfere with the absorption or metabolism of golcadomide, or put the study outcomes at undue risk
- Requires chronic treatment with strong CYP3A inhibitors (List in Table 8). Participants can be eligible after discontinuation of the perpetrator and a sufficient washout period of 7-days or 5 half-lives, whichever is longer.
- Uncontrolled human immunodeficiency virus (HIV) with positive viral load, or active Hepatitis C Virus, or active Hepatitis B Virus infection, or any uncontrolled active significant infection within 4 weeks before the start of treatment, including suspected or confirmed JC virus infection and SARSCoV2.
- Participants with inactive hepatitis B infection must adhere to hepatitis B reactivation prophylaxis unless contraindicated. The treatment and monitoring of hepatitis B will follow the institutional standard of practice. Hepatitis B or C serologic status: subjects who are hepatitis B core antibody (anti-HBc) positive and who are surface antigen negative will need to have a negative polymerase chain reaction (PCR). Those who are hepatitis B surface antigen (HbsAg) positive or hepatitis B PCR positive will be excluded. Subjects who are hepatitis C antibody positive will need to have a negative PCR result. Those who are hepatitis C PCR positive will be excluded. Subjects with a history of Hepatitis C who received antiviral treatment are eligible as long as PCR is negative.
- History of severe allergic or anaphylactic reactions or intolerance to anti-CD20 monoclonal antibody therapy or any bispecific antibody.
- History of immunodeficiency (with the exception of hypogammaglobulinemia) or concurrent systemic immunosuppressant therapy (e.g., cyclosporine, tacrolimus, etc., or chronic administration glucocorticoid equivalent of >20mg/day of prednisone) within 28 days of the first dose of study drug with exception of steroid used for IV contrast allergy. In addition, use of inhaled, topical, intranasal corticosteroids or local steroid injection (eg, intra- articular injection) is permitted.
- Clinically significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of Screening, or any Class 3 (moderate) or Class 4 (severe) cardiac disease as defined by the New York Heart Association NYHA) Functional Classification. Subjects with controlled, asymptomatic heart failure during screening can enroll on study.
- Significant screening electrocardiogram (ECG) abnormalities including left bundle branch block, 2nd degree atrioventricular (AV) block, type II AV block, or 3rd degree block.
- QTcF ≥ 470 msec
- History of stroke, seizure disorder or Participants requiring antiepileptic therapy or intracranial hemorrhage within 6 months prior to study entry.
- Vaccinated with live, attenuated vaccines within 4 weeks of study entry
- Lactating or pregnant subjects. Pregnant women are excluded from this study for potential teratogenic or abortifacient effects by golcadomide or glofitamab.
- Had blood transfusion within 14 days of first dose of study drug
- Administration of any investigational agent within 28 days of first dose of study drug
- Participants who have undergone major surgery within 28 days or minor surgery within 3 days of first dose of study drug
- Participants taking chronic corticosteroids for other diseases, unless administered at a dose equivalent to < 20 mg/day prednisone. For corticosteroids, prednisolone >20 mg daily (or equivalent) qualifies as immunosuppressive and thus is excluded for this use. Note: corticosteroids at any dose are permitted for control of lymphoma-related symptoms or potential immune related complication from the treatment, including during screening, and for prophylaxis or AE management during the trial
- Prior exposure to IMiDs, CD20 x CD3 bispecific antibodies, independently from indication
- Participants who have difficulty with or are unable to swallow oral medication, or have disease significantly affecting gastrointestinal function that would limit absorption of oral medication
- Participants who have any contraindication for prophylaxis against venous thromboembolism
- Participants for whom accurate assessment of neurologic toxicity is not feasible in the opinion of the investigator
- Participants who have an active autoimmune disease that has required systemic treatment in past 12 months (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed
- Participants with active pulmonary embolism or deep vein thrombosis (diagnosed within 30 days of study enrollment)
- Known history of Stevens-Johnson syndrome (SJS) or toxic epidermal necrolysis (TEN) or drug rash with eosinophilia and syst
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
UT MD Anderson Cancer Center
Houston, Texas, 77030
Dai Chihara, MD, 713-471-8176, DChihara@mdanderson.org
Dai Chihara, MD
About this study
To learn if the combination of golcadomide, obinutuzumab, glofitamab, and polatuzumab vedotin in LBCL participants can help to control the disease.
Read the detailed description
Primary Objectives
- To evaluate safety of G2P as treatment for participants with newly diagnosed LBCL
- To determine the overall response rate and complete response rate of G2P in p participants with newly diagnosed LBCL
- Conditions
- Multi Center, Phase 2, Golcadomide, Glofitamab, Polauzumab, Vedotin
- Being tested
- golcadomide, Obinutuzumab, Polatuzumab, Glofitamab
- Medical subject headings
- Lymphoma, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
golcadomideDrug
By mouth on Days 1-7 of each cycle
ObinutuzumabDrug
by vein over approximately 4-5 hours
PolatuzumabDrug
by vein over about 90 minutes on Day 1 of Cycles 1-6.
GlofitamabDrug
by vein over about 4 hours on Days 8 and 15 of Cycle 1,
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Patients with CR after Cycle 3 Receives: Drug: golcadomide; Drug: Obinutuzumab; Drug: Polatuzumab; Drug: Glofitamab |
| Group B | Experimental | Patients with less than CR after Cycle 3 Receives: Drug: golcadomide; Drug: Polatuzumab; Drug: Glofitamab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and adverse events (AEs)
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Measured: Through study completion; an average of 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2026
- Study start29 Apr 2027 (estimated)
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multi CenterStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Bristol-Myers Squibb, Genentech, Inc.
- Responsible party
- Sponsor
- Investigators
- Dai Chihara, MD, Principal investigator, UT MD Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07917832
- Sponsor's protocol ID
- 2025-1841
- Other IDs
- NCI-2026-08293
- Status last verified
- Nov 2026
- First submitted
- 3 Nov 2026
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Smart 3: A Multi-Center Phase 2 Trial Of Golcadomide, Glofitamab And Polatuzumab Vedotin (G2P) For Patients With Newly Diagnosed Large B-Cell Lymphoma
- ClinicalTrials.gov ID
- NCT07917832
- Acronym / sponsor ID
- 2025-1841
- Conditions
- Multi Center, Phase 2, Golcadomide, Glofitamab, Polauzumab, Vedotin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Bristol-Myers Squibb, Genentech, Inc.
- Study start
- 29 Apr 2027 (estimated)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2029 (estimated)
- First posted
- 5 Nov 2026 (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.
To learn if the combination of golcadomide, obinutuzumab, glofitamab, and polatuzumab vedotin in LBCL participants can help to control the disease.
Detailed description
Primary Objectives
- To evaluate safety of G2P as treatment for participants with newly diagnosed LBCL
- To determine the overall response rate and complete response rate of G2P in p participants with newly diagnosed LBCL
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Drug: golcadomide, Drug: Obinutuzumab, Drug: Polatuzumab, Drug: GlofitamabPatients with CR after Cycle 3 |
| Group B | Experimental | Drug: golcadomide, Drug: Polatuzumab, Drug: GlofitamabPatients with less than CR after Cycle 3 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (31 listed)
- Central nervous system involvement of lymphoma
- > Suspicious cases at the time of diagnosis should be evaluated with brain MRI with or without lumbar puncture
- Any prior history of other malignancy besides B-NHL, unless the Participant has been free of disease for ≥ 2 year and felt to be at low risk for recurrence by the treating physician, except:
- Any life-threatening illness, medical condition, or organ system dysfunction which, in the investigator's opinion, could compromise the subject's safety, interfere with the absorption or metabolism of golcadomide, or put the study outcomes at undue risk
- Requires chronic treatment with strong CYP3A inhibitors (List in Table 8). Participants can be eligible after discontinuation of the perpetrator and a sufficient washout period of 7-days or 5 half-lives, whichever is longer.
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 |
|---|---|---|
| golcadomideBy mouth on Days 1-7 of each cycle | Drug | Group A, Group B |
| Obinutuzumabby vein over approximately 4-5 hours | Drug | Group A |
| Polatuzumabby vein over about 90 minutes on Day 1 of Cycles 1-6. | Drug | Group A, Group B |
| Glofitamabby vein over about 4 hours on Days 8 and 15 of Cycle 1, | Drug | Group A, Group B |
Primary outcome
Safety and adverse events (AEs)
Time frame: Through study completion; an average of 1 year.
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
- UT MD Anderson Cancer CenterLink provided by the sponsor.
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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.
Dai Chihara, MD principal investigator
UT MD Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing golcadomide, Obinutuzumab and Polatuzumab in people with Multi Center and Phase 2, run by M.D. Anderson Cancer Center at 1 site 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 0 inclusion and 31 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: opening soon, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dai Chihara, MD (713-471-8176, DChihara@mdanderson.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and adverse events (AEs) (time frame: Through study completion; an average of 1 year.). 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 5 Nov 2026; AzTrials last refreshed its copy on 6 Nov 2026.