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This is a Phase 1/2 dose-escalation study of BTCT4465A (Mosunetuzumab) administered as a single agent and in combination with atezolizumab in participants with relapsed or refractory B-cell NHL and CLL. The study will consist of a dose-escalation stage and an expansion stage where participants will be enrolled into indication-specific cohorts.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose Escalation | Experimental | Participants will receive BTCT4465A (Mosunetuzumab) via intravenous (IV) infusion or subcutaneous (SC) injection as a single-agent or in combination with atezolizumab. Dose escalation will be guided by the observed incidence of DLTs at each dose level. |
|
| Dose Expansion | Experimental | Participants will receive BTCT4465A (Mosunetuzumab) as a single-agent or in combination with atezolizumab. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BTCT4465A (Mosunetuzumab) IV | Drug | Participants with B-cell NHL and CLL will receive BTCT4465A (Mosunetuzumab) via IV infusion. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Tolerated Dose (MTD) of BTCT4465A (Mosunetuzumab) | BTCT4465A (Mosunetuzumab) single agent: Cycle 1; BTCT4465A (Mosunetuzumab) in combination with atezolizumab: during the first cycle that BTCT4465A (Mosunetuzumab) and atezolizumab are administered concurrently (cycle length = 21 days) | |
| Percentage of Participants With Adverse Events | Cycle 1 Day 1 until 90 days after the last infusion (cycle length = 21 days; up to approximately 14 months) | |
| BTCT4465A (Mosunetuzumab) Serum Concentration | Baseline up to 30 days after the last infusion of BTCT4465A (Mosunetuzumab) (up to approximately 12 months) | |
| Atezolizumab Serum Concentration | Baseline up to 30 days after the last infusion of BTCT4465A (Mosunetuzumab) (up to approximately 12 months) | |
| Percentage of Participants with Complete Response as Assessed Using Standard Criteria for NHL | Baseline up to approximately 4 years (assessed at screening and then every 3 months until disease progression, start of new anti-cancer therapy, or withdrawal) |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Response as Assessed Using Standard Criteria for NHL | Baseline up to approximately 4 years (assessed at screening and then every 3 months until disease progression, start of new anti-cancer therapy, or withdrawal) | |
| Progression-Free Survival (PFS) as Assessed Using Standard Criteria for NHL |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California San Diego Moores Cancer Center | La Jolla | California | 92093-0698 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41862428 | Derived | Bartlett NL, Sehn LH, Assouline S, Giri P, Kuruvilla J, Schuster SJ, Yoon SS, Fay K, Hess G, Dreyling M, Gutierrez NC, Cybulski E, Sabalvaro F, Penuel E, Teodoro V, Tracy S, Kuruvilla D, Chen J, Wiebking V, Wei MC, Budde LE. Fixed-Duration Subcutaneous Mosunetuzumab in Relapsed/Refractory Follicular Lymphoma: Pivotal Phase 2 Primary Analysis. Am J Hematol. 2026 May;101(5):986-997. doi: 10.1002/ajh.70225. Epub 2026 Mar 20. | |
| 41643182 |
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For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data\_sharing.
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| Atezolizumab | Drug | Participants assigned to an atezolizumab combination group will receive atezolizumab 1200 mg administered as an IV infusion in combination with BTCT4465A (Mosunetuzumab). |
|
|
| BTCT4465A (Mosunetuzumab) SC | Drug | Participants with B-cell NHL and CLL will receive BTCT4465A (Mosunetuzumab) via SC injection. |
|
| Baseline up to approximately 4 years (assessed at screening and then every 3 months until disease progression, start of new anti-cancer therapy, withdrawal, or death from any cause) |
| Overall Survival | Baseline until death from any cause (up to approximately 4 years) |
| European Organisation for Research and Treatment of Cancer Quality-of-Life Questionnaire Core 30 (EORTC QLQ-C30) Scores to Assess Health-Related Quality of Life (HRQoL) | The Functional Assessment of Cancer Therapy-Lymphoma (FACT-lym) Subscale, and the EuroQol 5 Dimension-5 Level (EQ-5D-5L) Questionnaire scores will also be used to assess HRQoL | Baseline until disease progression, start of new anti-cancer therapy, or withdrawal (up to approximately 4 years). |
| Objective Response Rate (ORR) | Baseline up to approximately 4 years (assessed at screening and then every 3 months until disease progression, start of new anti-cancer therapy, or withdrawal) |
| Sansum Medical Clinic, Inc. |
| Santa Barbara |
| California |
| 93105 |
| United States |
| Rocky Mountain Cancer Center | Denver | Colorado | 80218 | United States |
| Yale University School Of Medicine | New Haven | Connecticut | 06510 | United States |
| Hackensack University Medical Center | Hackensack | New Jersey | 07601 | United States |
| Memorial Sloan Kettering Bergen | Montvale | New Jersey | 07645 | United States |
| Memorial Sloan Kettering Cancer Center - Commack | Commack | New York | 11725 | United States |
| Memorial Sloan Kettering Cancer Center at Westchester | Harrison | New York | 10604 | United States |
| New York Uni Medical Center | New York | New York | 10016 | United States |
| Willamette Valley Cancer Insitute and Research Center | Springfield | Oregon | 97477 | United States |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19103 | United States |
| MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
| St Vincent's Hospital Sydney | Darlinghurst | New South Wales | 2010 | Australia |
| Icon Cancer Care South Brisbane | South Brisbane | Queensland | 4101 | Australia |
| Princess Alexandra Hospital | Woolloongabba | Queensland | 4102 | Australia |
| Royal Adelaide Hospital | Adelaide | South Australia | 5000 | Australia |
| St. Vincent's Hospital Melbourne | Fitzroy | South Australia | 3065 | Australia |
| Royal Hobart Hospital | Hobart | Tasmania | 7000 | Australia |
| Monash Health Clinical Trial Pharmacy department | Clayton | Victoria | 3168 | Australia |
| The Perth Blood Institute | Nedlands | Western Australia | 6009 | Australia |
| Princess Margaret Hospital | Toronto | Ontario | M5G 2M9 | Canada |
| Jewish General Hospital | Montreal | Quebec | H3T 1E2 | Canada |
| Universitatsklinikum Koln | Cologne | 50931 | Germany |
| Universitätsklinikum Heidelberg | Heidelberg | 69120 | Germany |
| Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz | Mainz | 55101 | Germany |
| Klinikum der Universität München, Campus Großhadern | München | 83177 | Germany |
| Seoul National University Hospital | Seoul | 03080 | South Korea |
| Samsung Medical Center | Seoul | 06351 | South Korea |
| ClÃnica Universidad de Navarra | Pamplona | Navarre | 31008 | Spain |
| Hospital Universitario Vall d Hebron | Barcelona | 08035 | Spain |
| Hospital Universitario La Paz | Madrid | 280146 | Spain |
| Complejo Asistencial Universitario de Salamanca | Salamanca | 37007 | Spain |
| Barts Cancer Institute | London | EC1A 7BE | United Kingdom |
| The Christie NHS Foundation Trust | Manchester | M20 4BX | United Kingdom |
| Royal Marsden Hospital;Institute of Cancer Research | Sutton | SM2 5PT | United Kingdom |
| Derived |
| Lewis KL, Assouline SE, Baker R, Bartlett NL, El-Sharkawi D, Giri P, Ku M, Matasar M, Schuster S, Radford J, Wei MC, Yin S, Kwan A, To I, Raghavan V, Budde LE, Cheah CY. Mosunetuzumab monotherapy is active and tolerable in patients with relapsed/refractory Richter transformation. Blood Adv. 2026 May 12;10(9):3011-3019. doi: 10.1182/bloodadvances.2025017914. |
| 40472301 | Derived | Danilov AV, Kambhampati Thiruvengadam S, Linton K, Cumings K, Chirikov V, Mutebi A, Bains Chawla S, Chhibber A, Rivas Navarro F, Marques Goncalves F, Wang A, Ding Z, Alshreef A, Favaro E, Hoehn D, Sureda A. Indirect comparison of epcoritamab vs chemoimmunotherapy, mosunetuzumab, or odronextamab in follicular lymphoma. Blood Adv. 2025 Aug 12;9(15):3754-3765. doi: 10.1182/bloodadvances.2024015274. |
| 40279333 | Derived | Li J, Liao MZ, Wilkins J, Penuel E, Wang B, Vadhavkar S, Peng K, Cao J, Li Z, Zhang Y, Li W, Li D, Zhou M, Wei MC, Kwan A, Zhao R, Li C, Li CC, Turner DC. Ethnic Sensitivity Assessment of Mosunetuzumab Pharmacokinetics and Pharmacodynamics in Chinese Patients With Relapsed or Refractory Follicular Lymphoma. Clin Transl Sci. 2025 May;18(5):e70211. doi: 10.1111/cts.70211. |
| 39571171 | Derived | Chong EA, Penuel E, Napier EB, Lundberg RK, Budde LE, Shadman M, Matasar MJ, Bartlett NL, Flinn IW, Bosch F, Fay K, Goy A, Kumar A, Nastoupil LJ, Wei MC, Wu M, Yin S, Fraietta JA, Chong ER, Schuster SJ. Impact of prior CAR T-cell therapy on mosunetuzumab efficacy in patients with relapsed or refractory B-cell lymphomas. Blood Adv. 2025 Feb 25;9(4):696-703. doi: 10.1182/bloodadvances.2024013640. |
| 39447094 | Derived | Sehn LH, Bartlett NL, Matasar MJ, Schuster SJ, Assouline SE, Giri P, Kuruvilla J, Shadman M, Cheah CY, Dietrich S, Fay K, Ku M, Nastoupil LJ, Wei MC, Yin S, To I, Kaufman D, Kwan A, Penuel E, Bolen CR, Budde LE. Long-term 3-year follow-up of mosunetuzumab in relapsed or refractory follicular lymphoma after >/=2 prior therapies. Blood. 2025 Feb 13;145(7):708-719. doi: 10.1182/blood.2024025454. |
| 38901633 | Derived | Ray MD, Kanters S, Beygi S, Best T, Wulff J, Limbrick-Oldfield E, Patel AR, Oluwole OO. Matching-Adjusted Indirect Comparisons of Axicabtagene Ciloleucel to Mosunetuzumab for the Treatment of Relapsed/Refractory Follicular Lymphoma. Transplant Cell Ther. 2024 Sep;30(9):885.e1-885.e11. doi: 10.1016/j.jtct.2024.06.016. Epub 2024 Jun 19. |
| 38843483 | Derived | Jemaa S, Ounadjela S, Wang X, El-Galaly TC, Kostakoglu L, Knapp A, Ku G, Musick L, Sahin D, Wei MC, Yin S, Bengtsson T, De Crespigny A, Carano RAD. Automated Lugano Metabolic Response Assessment in 18F-Fluorodeoxyglucose-Avid Non-Hodgkin Lymphoma With Deep Learning on 18F-Fluorodeoxyglucose-Positron Emission Tomography. J Clin Oncol. 2024 Sep 1;42(25):2966-2977. doi: 10.1200/JCO.23.01978. Epub 2024 Jun 6. |
| 38808543 | Derived | Bender B, Li CC, Marchand M, Turner DC, Li F, Vadhavkar S, Wang B, Deng R, Lu J, Jin J, Li C, Yin S, Wei M, Chanu P. Population pharmacokinetics and CD20 binding dynamics for mosunetuzumab in relapsed/refractory B-cell non-Hodgkin lymphoma. Clin Transl Sci. 2024 Jun;17(6):e13825. doi: 10.1111/cts.13825. |
| 38547425 | Derived | Budde LE, Assouline S, Sehn LH, Schuster SJ, Yoon SS, Yoon DH, Matasar MJ, Bosch F, Kim WS, Nastoupil LJ, Flinn IW, Shadman M, Diefenbach C, Cheah CY, Ma CY, Huang H, Kwan A, Wei MC, Yin S, Bartlett NL. Durable Responses With Mosunetuzumab in Relapsed/Refractory Indolent and Aggressive B-Cell Non-Hodgkin Lymphomas: Extended Follow-Up of a Phase I/II Study. J Clin Oncol. 2024 Jul 1;42(19):2250-2256. doi: 10.1200/JCO.23.02329. Epub 2024 Mar 28. |
| 38048694 | Derived | Schuster SJ, Huw LY, Bolen CR, Maximov V, Polson AG, Hatzi K, Lasater EA, Assouline SE, Bartlett NL, Budde LE, Matasar MJ, Koeppen H, Piccione EC, Wilson D, Wei MC, Yin S, Penuel E. Loss of CD20 expression as a mechanism of resistance to mosunetuzumab in relapsed/refractory B-cell lymphomas. Blood. 2024 Feb 29;143(9):822-832. doi: 10.1182/blood.2023022348. |
| 37981564 | Derived | Bosch F, Kuruvilla J, Vassilakopoulos TP, Maio DD, Wei MC, Zumofen MB, Nastoupil LJ. Indirect Treatment Comparisons of Mosunetuzumab With Third- and Later-Line Treatments for Relapsed/Refractory Follicular Lymphoma. Clin Lymphoma Myeloma Leuk. 2024 Feb;24(2):105-121. doi: 10.1016/j.clml.2023.09.007. Epub 2023 Sep 28. |
| 37851321 | Derived | Sanchez Alvarez J, Jaber M, Blanchet Zumofen MH. Multiple Real-World Data Sources in a Bayesian Framework to Inform Long-Term Survival Estimates of Mosunetuzumab in Patients with Follicular Lymphoma. Oncol Ther. 2023 Dec;11(4):495-511. doi: 10.1007/s40487-023-00245-4. Epub 2023 Oct 18. |
| 37067952 | Derived | Bartlett NL, Assouline S, Giri P, Schuster SJ, Cheah CY, Matasar M, Gregory GP, Yoon DH, Shadman M, Fay K, Yoon SS, Panizo C, Flinn I, Johnston A, Bosch F, Sehn LH, Wei MC, Yin S, To I, Li CC, Huang H, Kwan A, Penuel E, Budde LE. Mosunetuzumab monotherapy is active and tolerable in patients with relapsed/refractory diffuse large B-cell lymphoma. Blood Adv. 2023 Sep 12;7(17):4926-4935. doi: 10.1182/bloodadvances.2022009260. |
| 35803286 | Derived | Budde LE, Sehn LH, Matasar M, Schuster SJ, Assouline S, Giri P, Kuruvilla J, Canales M, Dietrich S, Fay K, Ku M, Nastoupil L, Cheah CY, Wei MC, Yin S, Li CC, Huang H, Kwan A, Penuel E, Bartlett NL. Safety and efficacy of mosunetuzumab, a bispecific antibody, in patients with relapsed or refractory follicular lymphoma: a single-arm, multicentre, phase 2 study. Lancet Oncol. 2022 Aug;23(8):1055-1065. doi: 10.1016/S1470-2045(22)00335-7. Epub 2022 Jul 5. |
| 34914545 | Derived | Budde LE, Assouline S, Sehn LH, Schuster SJ, Yoon SS, Yoon DH, Matasar MJ, Bosch F, Kim WS, Nastoupil LJ, Flinn IW, Shadman M, Diefenbach C, O'Hear C, Huang H, Kwan A, Li CC, Piccione EC, Wei MC, Yin S, Bartlett NL. Single-Agent Mosunetuzumab Shows Durable Complete Responses in Patients With Relapsed or Refractory B-Cell Lymphomas: Phase I Dose-Escalation Study. J Clin Oncol. 2022 Feb 10;40(5):481-491. doi: 10.1200/JCO.21.00931. Epub 2021 Dec 16. |
| ID | Term |
|---|---|
| D015451 | Leukemia, Lymphocytic, Chronic, B-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| ID | Term |
|---|---|
| D015448 | Leukemia, B-Cell |
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008223 | Lymphoma |
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| ID | Term |
|---|---|
| C000594389 | atezolizumab |
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