ClinicalTrials.gg
Not yet recruitingNCT07917832Updated Nov 5, 2026

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 interventional study of golcadomide and Obinutuzumab in Multi Center, Phase 2 and Golcadomide, sponsored by M.D. Anderson Cancer Center. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-05.

Sponsored by M.D. Anderson Cancer Center · Phase 2, Interventional, and Treatment

Updated Nov 5, 2026Newly registeredGo to Updates ↓
Phase
Phase 2
Study type
Interventional
Enrollment
60
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

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
02

Conditions studied

  • Multi Center
  • Phase 2
  • Golcadomide
  • Glofitamab
  • Polauzumab
  • Vedotin
  • G2p
  • B Cell Lymphoma

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03

In context

Lymphoma, B-Cell

885 studies on the registry are indexed under Lymphoma, B-Cell; 286 are open to participants now.

This study's planned enrollment of 60 is above the median of 34 across 773 interventional studies indexed under Lymphoma, B-Cell.

Browse Lymphoma, B-Cell studies →

Lead sponsor

M.D. Anderson Cancer Center is the lead sponsor of 3,047 studies on the registry; 578 are open to participants now.

Of its 612 completed or terminated interventional studies of FDA-regulated products, 409 (67%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Eligibility Criteria

Participants must meet the following criteria for study entry:

  • Age ≥18 years
  • diagnosed

    • Diffuse large B-cell lymphoma, not otherwise specified (NOS) or
    • High grade B-cell lymphoma (NOS or MYC and BCL2 rearrangements) o Transformed indolent lymphomas are eligible
  • Ann Arbor stage II bulky (maximum dimension ≥7.5cm), III or IV
  • International Prognostic Index score ≥2
  • Participants must have bi-dimensional , as defined as radiographically apparent disease with the longest dimension of ≥1.5cm
  • Performance status ≤2 on the scale, or 3 if related to lymphoma
  • Participants must have adequate organ and marrow function as defined below:

    • (ANC) ≥1.0 × 109 /L
    • count ≥75 × 109 /L
    • ≥ 8 g/dL
    • Total ≤ 3 , unless consistent with Gilbert's
    • and ALT ≤ 5x upper limit of normal (ULN)
    • Alkaline phosphatase \< 2.5 ULN
    • >30 ml/min calculated by modified Cockcroft-Gault formula or > 30 ml/min/1.73m2
    • Cardiac ≥ 50%, no evidence of pericardial effusion (except trace or physiological) as determined by an echocardiogram (ECHO) or MUGA, and no (ECG) findings
  • All subjects must

    • Have an understanding that the study drug could have a potential teratogenic risk
    • Agree to refrain from donating blood while on study treatment, during dose interruptions and for at least 12 months following the last dose of study treatment
    • Agree not to share study medication with another person
    • Agree to follow all requirements defined in the Pregnancy Prevention Program (see for golcadomide Pregnancy Prevention Plan for Subjects in Clinical trials
    • Females must refrain from donating egg while on study and for at least 28 days after the last dose of golcadomide.
  • Females must agree to abstain from breastfeeding while taking golcadomide and for at least 28 days after the last dose of golcadomide
  • Women of and men must agree to use adequate (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation (Refer to Pregnancy Assessment Policy MD Anderson Institutional Policy # CLN1114 and ARMM Checklist Appendix 14.6). This includes all female patients, between the onset of menses (as early as 8 years of age) and 50 years unless the Participant presents with an applicable exclusionary factor which may be one of the following:

    • (no menses in greater than or equal to 12 consecutive months)
    • History of hysterectomy or bilateral salpingo-oophorectomy
    • Ovarian failure (Follicle Stimulating Hormone and Estradiol in menopausal range, who have received Whole Pelvic Radiation Therapy)
    • History of bilateral tubal ligation or another surgical sterilization procedure
  • Females of childbearing potential (FCBP§) must:

    • Have two negative pregnancy tests as verified by the investigator prior to starting study therapy. She must agree to ongoing pregnancy testing during the course of the study, and after end of study therapy. This applies even if the subject practices true abstinence* from heterosexual contact
    • a negative serum or urine pregnancy test at Screening (within 10-14 days prior to Cycle 1 Day 1) of study treatment
    • a negative serum or urine pregnancy test (Investigator's discretion) within 24 hours prior to Cycle 1 Day 1 of study treatment
    • Either commit to true abstinence* from heterosexual contact (which must be reviewed on a monthly basis and source documented) or agree to use, and be able to comply with two forms of contraception: one highly effective, and one additional effective (barrier) measure of contraception without interruption 28 days prior to starting IP, during the study treatment (including dose interruptions), and for 28 days after the last dose of golcadomide, 2 months after the last dose of glofitamab, 9 months after the last dose of polatuzumab and for 18 months after the last dose of obinutuzumab or 3 months after the last dose of tocilizumab (if applicable), whichever is longer. Contraception requirements are detailed in
  • Male subjects must:

    • Participants must agree to either remain completely abstinent or to use two effective contraceptive methods that result in a failure rate of \< 1% per year from screening until at least 28 days after the last dose of golcadomide, 3 months after pre-treatment with obinutuzumab, 2 months after the last dose of glofitamab, 6 months after the last dose of polatuzumab, or 2 months after the last dose of tocilizumab (if applicable), whichever is longer

      ), during sexual contact with a pregnant female or a female of childbearing potential while participating in the study

    • Must agree to refrain from donating sperm while on study treatment, during dose interruptions, and for at least 3 months and 2 weeks after the last dose of golcadomide or obinutuzumab, whichever is longer
    • Sign an document indicating that they understand the purpose of and procedures required for the study, including biomarkers, and are willing to participate in the study
  • The investigator is responsible for: ensuring that the Participant understands the potential risks and benefits of participating in the study; ensuring that informed consent is given by each patient, this includes obtaining the appropriate signatures and dates on the informed consent document prior to the performance of any study procedures and prior to the administration of study treatment; answering any questions the Participant may have throughout the study and sharing in a timely manner any new information that may be relevant to the patient's willingness to continue his or her participant in the trial. Subjects will undergo a brief physical exam including a brief exam to determine cognitive review. No one without capacity to personally consent will be enrolled. Patients have medical decision-making capacity if they can demonstrate understanding of the situation, appreciation of the consequences of their decision, and reasoning in their thought process, and if they can communicate their wishes
  • A determination of lack of decision-making capacity shall be made after an appropriate medical evaluation that concludes there is little or no likelihood that the participant will regain decisionmaking capacity in a reasonable period of time
  • §A FCBP is a female who: 1) has achieved menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy, or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 12 consecutive months
  • Participants must be willing and able to comply with the protocol treatment and procedures
  • Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria

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 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
    • 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 inhibitors (List in Table 8). Participants can be eligible after discontinuation of the perpetrator and a sufficient of 7-days or 5 half-lives, whichever is longer.
  • Uncontrolled (HIV) with positive viral load, or active Virus, or active 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 . 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 therapy (e.g., cyclosporine, tacrolimus, etc., or chronic administration 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 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.
  • ≥ 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 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 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
Terms in these criteria, in plain language(31)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Histologically or cytologically confirmed

The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).

Your pathology report is the document that shows this.

Measurable disease

The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.

The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Absolute neutrophil count (ANC)

The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.

It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

Bilirubin

A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.

Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

Creatinine clearance (CrCl)

How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

LVEF (left ventricular ejection fraction)

The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Postmenopausal

Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

CYP3A (CYP3A4) inhibitors and inducers

CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.

Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.

Washout period

A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.

QT and QTc

On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.

The study may name a correction formula and a limit in milliseconds, often around 450–480.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    Group A

    Patients with CR after Cycle 3

    Drug: golcadomide · Drug: Obinutuzumab · Drug: Polatuzumab · Drug: Glofitamab

  • Experimental
    Group B

    Patients with less than CR after Cycle 3

    Drug: golcadomide · Drug: Polatuzumab · Drug: Glofitamab

Interventions

  • By mouth on Days 1-7 of each cycle

  • by vein over approximately 4-5 hours

  • by vein over about 90 minutes on Day 1 of Cycles 1-6.

  • by vein over about 4 hours on Days 8 and 15 of Cycle 1,

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: Through study completion; an average of 1 year.

07

Study locations

1 site
08

References and documents

09

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Nov 5, 2026
Show all 1 update
  1. Nov 5, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07917832
Responsible party
Sponsor
First posted
Nov 5, 2026
Start date
Apr 29, 2027 (estimated)
Primary completion
Jun 30, 2027 (estimated)
Completion
Jun 30, 2029 (estimated)
Last update
Nov 5, 2026

Study contacts

Dai Chihara, MD
Contact
DChihara@mdanderson.org
713-471-8176
Dai Chihara, MD
principal investigator · UT MD Anderson Cancer Center

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

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Studies of the drugs tested here: Golcadomide · Polatuzumab · Glofitamab

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