Last update 05 Aug 2026

Glofitamab

Overview

Basic Info

Drug Type
Bispecific T-cell Engager (BiTE)
Synonyms
Anti-CD20/CD3 bispecific monoclonal antibody, Anti-CD20/CD3 bispecific monoclonal antibody RO7082859, Glofitamab (USAN/INN)
+ [14]
Action
inhibitors, stimulants
Mechanism
CD20 inhibitors(B-lymphocyte antigen CD20 inhibitors), CD3 stimulants(T cell surface glycoprotein CD3 stimulants), ADCC(Antibody-dependent cell-mediated cytotoxicity (ADCC) effects)
Inactive Indication-
Originator Organization
Inactive Organization-
License Organization
Drug Highest PhaseApproved
RegulationAccelerated Approval (United States), Orphan Drug (European Union), Conditional marketing approval (China), Orphan Drug (Japan), Orphan Drug (Australia), Conditional marketing approval (European Union), Breakthrough Therapy (China), Priority Review (United States), Conditional marketing approval (Canada), Priority Review (China)
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Structure/Sequence

External Link

KEGGWikiATCDrug Bank
D11833--

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Diffuse large B-cell lymphoma recurrent
Canada
25 Mar 2023
Diffuse large B-cell lymphoma refractory
Canada
25 Mar 2023
Diffuse Large B-Cell Lymphoma
Canada
24 Mar 2023
Follicular Lymphoma
Canada
24 Mar 2023
High grade B-cell lymphoma
Canada
24 Mar 2023
Mediastinal large B-cell lymphoma
Canada
24 Mar 2023
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Mantle-Cell LymphomaPhase 3
United States
09 Oct 2023
Mantle-Cell LymphomaPhase 3
China
09 Oct 2023
Mantle-Cell LymphomaPhase 3
Australia
09 Oct 2023
Mantle-Cell LymphomaPhase 3
Brazil
09 Oct 2023
Mantle-Cell LymphomaPhase 3
Canada
09 Oct 2023
Mantle-Cell LymphomaPhase 3
France
09 Oct 2023
Mantle-Cell LymphomaPhase 3
Italy
09 Oct 2023
Mantle-Cell LymphomaPhase 3
South Korea
09 Oct 2023
Mantle-Cell LymphomaPhase 3
Spain
09 Oct 2023
Mantle-Cell LymphomaPhase 3
Sweden
09 Oct 2023
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Not Applicable
936
CAR T-cell therapy
rrivllzsiw(hkkefdwctj) = qadmaberlf iiyqekotuy (xpqdfryllr )
Positive
29 May 2026
Bispecific antibodies
rrivllzsiw(hkkefdwctj) = zezsmbmhkk iiyqekotuy (xpqdfryllr )
Phase 1
255
(relapsed or refractory B-cell NHL or nTFHL)
hqvbsskuig(loidkevzgm) = dltxqmvmzk jnnuxodadp (gscevgubhk )
Positive
29 May 2026
Not Applicable
410
eubldynlfj(qewxmayykh) = 19.0% vs 25.4% dtopwzplih (yeayhzdmef )
Positive
29 May 2026
Not Applicable
63
sjtogvhydd(tchmztrbvl) = xywimupbkz uekfggqwrw (ckezmzixpi )
Positive
29 May 2026
sjtogvhydd(zeyihaeqcg) = wxcxzbgifz oxnxzoxuvi (olyhldkqxi )
Phase 1/2
60
pxpkwwzxgc(uuzwovkkmf) = ybuwwyvqlf xeforsuawz (ztznfllvdn )
Positive
29 May 2026
(prior BTKi therapy)
pxpkwwzxgc(uuzwovkkmf) = jjaoejxgwa xeforsuawz (ztznfllvdn )
Not Applicable
3,642
bispecific T-cell engager therapy
kjzjyvagen(vmguwksnma) = jmmmcxvyll iqqatvvaav (xbxaogjvvo )
Positive
29 May 2026
Phase 1/2
61
ucljxhsime(bbfduzdjvr) = Cytokine release syndrome remained the most common adverse event (all Grade, n=42/60, 70%; Grade 1-2, 58.3%; Grade 3-4, 11.6%; no Grade 5 events), with lower rates reported in the 2000mg Gpt cohort (n=28/44, 63.6%) compared with the 1000mg Gpt cohort (n=14/16, 87.5%). aobyxmidwc (ccrguvcvuo )
Positive
21 May 2026
(received prior BTKi therapy)
Not Applicable
1,442
CAR-T-cells
jwrttzmlqt(adbrjsfyql) = qnkqgtgjqz nhtwmrjcnp (gsptddkutf )
Positive
12 May 2026
(DLBCL)
jwrttzmlqt(adbrjsfyql) = mcmfbmjniz nhtwmrjcnp (gsptddkutf )
Not Applicable
32
(Mixed cohort (monotherapy and combination))
ceizkiwlzl(bvpsbhlxhv) = Grade 1-2 cytokine release syndrome occurred in 28.1% with no grade ≥3 CRS or ICANS. Hematologic toxicity (78.1%) and infections were predominant; 2 patients died from severe infections. fkjlsxtxkc (mndjswscfc )
Positive
12 May 2026
(salvage therapy)
Not Applicable
40
jgkfmpajhf(tguestsxmd) = jvymkdphpm vkiwtmhjfv (ztvziptdos )
Positive
12 May 2026
jgkfmpajhf(tguestsxmd) = avnihtjkgx vkiwtmhjfv (ztvziptdos )
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Core Patent

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Clinical Trial

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Approval

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Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.
Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

Regulation

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