TriangleNCT02500407 · CITED IN SOURCE DOCUMENTS
A Safety, Efficacy and Pharmacokinetic Study of BTCT4465A (Mosunetuzumab) as a Single Agent and Combined With Atezolizumab in Non-Hodgkin's Lymphoma (NHL) and Chronic Lymphocytic Leukemia (CLL)
An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.
- Phase
- PHASE1, PHASE2
- Status at capture
- COMPLETED
- Registry last update
- 2025-09-12
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.
Open the original ClinicalTrials.gov record → · Download preserved record
What did the study report?
Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.
No posted result sections were captured. Registered plans do not establish that a treatment works.
Who could take part
- eligibility Criteria
- Key Inclusion Criteria: * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * B-cell hematologic malignancies expected to express the cluster of differentiation 20 (CD20) antigen who have relapsed after or failed to respond to at least one prior treatment regimen and for whom there is no available therapy expected to improve survival * Adequate hepatic, hematologic, and renal function Key Exclusion Criteria: * Pregnant or lactating women * Monoclonal antibody, radioimmunoconjugate, antibody-drug conjugate, chemotherapy, or other investigational anti-cancer agent within 4 weeks prior to study drug * Treatment with radiotherapy within 2 weeks prior to the first BTCT4465A (Mosunetuzumab) administration * Systemic immunosuppressive medication within 2 weeks prior to study drug * Autologous stem cell transplantation (SCT) within 100 days prior to study drug, or any prior allogeneic SCT or solid organ transplantation * Autoimmune disease with the exception of controlled/treated hypothyroidism, disease-related immune thrombocytopenic purpura, or hemolytic anemia * History of central nervous system (CNS) lymphoma or other CNS disease * Significant cardiovascular or pulmonary disease * Hepatitis B or C or human immunodeficiency virus (HIV) * Receipt of a live attenuated vaccine within 4 weeks prior to study drug * Prior treatment with chimeric antigen receptor T-cell (CAR-T) therapy within 30 days before first BTCT4465A (Mosunetuzumab) administration
- healthy Volunteers
- false
- minimum Age
- 18 Years
- sex
- ALL
- std Ages
- ADULT
- OLDER_ADULT
Treatment arms and interventions
- arm Groups
- description
- 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.
- intervention Names
- Drug: BTCT4465A (Mosunetuzumab) IV
- Drug: Atezolizumab
- Drug: BTCT4465A (Mosunetuzumab) SC
- label
- Dose Escalation
- type
- EXPERIMENTAL
- description
- Participants will receive BTCT4465A (Mosunetuzumab) as a single-agent or in combination with atezolizumab.
- intervention Names
- Drug: BTCT4465A (Mosunetuzumab) IV
- Drug: Atezolizumab
- Drug: BTCT4465A (Mosunetuzumab) SC
- label
- Dose Expansion
- type
- EXPERIMENTAL
- interventions
- arm Group Labels
- Dose Escalation
- Dose Expansion
- description
- Participants with B-cell NHL and CLL will receive BTCT4465A (Mosunetuzumab) via IV infusion.
- name
- BTCT4465A (Mosunetuzumab) IV
- type
- DRUG
- arm Group Labels
- Dose Escalation
- Dose Expansion
- description
- Participants assigned to an atezolizumab combination group will receive atezolizumab 1200 mg administered as an IV infusion in combination with BTCT4465A (Mosunetuzumab).
- name
- Atezolizumab
- other Names
- Tecentriq
- type
- DRUG
- arm Group Labels
- Dose Escalation
- Dose Expansion
- description
- Participants with B-cell NHL and CLL will receive BTCT4465A (Mosunetuzumab) via SC injection.
- name
- BTCT4465A (Mosunetuzumab) SC
- type
- DRUG
Study design
- allocation
- NON_RANDOMIZED
- intervention Model
- SEQUENTIAL
- masking Info
- masking
- NONE
- primary Purpose
- TREATMENT
Enrollment
- count
- 713
- type
- ACTUAL
Registered outcome plans (not posted results)
- primary Outcomes
- measure
- Maximum Tolerated Dose (MTD) of BTCT4465A (Mosunetuzumab)
- time Frame
- 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)
- measure
- Percentage of Participants With Adverse Events
- time Frame
- Cycle 1 Day 1 until 90 days after the last infusion (cycle length = 21 days; up to approximately 14 months)
- measure
- BTCT4465A (Mosunetuzumab) Serum Concentration
- time Frame
- Baseline up to 30 days after the last infusion of BTCT4465A (Mosunetuzumab) (up to approximately 12 months)
- measure
- Atezolizumab Serum Concentration
- time Frame
- Baseline up to 30 days after the last infusion of BTCT4465A (Mosunetuzumab) (up to approximately 12 months)
- measure
- Percentage of Participants with Complete Response as Assessed Using Standard Criteria for NHL
- time Frame
- 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)
- secondary Outcomes
- measure
- Duration of Response as Assessed Using Standard Criteria for NHL
- time Frame
- 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
- Progression-Free Survival (PFS) as Assessed Using Standard Criteria for NHL
- time Frame
- 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)
- measure
- Overall Survival
- time Frame
- Baseline until death from any cause (up to approximately 4 years)
- description
- 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
- measure
- 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)
- time Frame
- Baseline until disease progression, start of new anti-cancer therapy, or withdrawal (up to approximately 4 years).
- measure
- Objective Response Rate (ORR)
- time Frame
- 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)
Full study description
- brief Summary
- 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.
Source references
- references
- citation
- 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.
- pmid
- 41862428
- type
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- type
- DERIVED
- citation
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- pmid
- 40472301
- type
- DERIVED
- citation
- 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.
- pmid
- 40279333
- type
- DERIVED
- citation
- 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.
- pmid
- 39571171
- type
- DERIVED
- citation
- 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.
- pmid
- 39447094
- type
- DERIVED
- citation
- Li CC, Bender B, Wilkins J, Li F, Turner DC, Wang B, Deng R, Vadhavkar S, Li Z, Kwan A, Huang H, Peng K, Penuel E, Huw LY, Chanu P, Li C, Yin S, Wei MC. A Novel Step-Up Dosage Regimen for Enhancing the Benefit-to-Risk Ratio of Mosunetuzumab in Relapsed or Refractory Follicular Lymphoma. Clin Pharmacol Ther. 2025 Feb;117(2):465-474. doi: 10.1002/cpt.3445. Epub 2024 Sep 27.
- pmid
- 39328022
- type
- DERIVED
- citation
- 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.
- pmid
- 38901633
- type
- DERIVED
- citation
- 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.
- pmid
- 38843483
- type
- DERIVED
- citation
- 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.
- pmid
- 38808543
- type
- DERIVED
- citation
- 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.
- pmid
- 38547425
- type
- DERIVED
- citation
- 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.
- pmid
- 38048694
- type
- DERIVED
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Preserved source evidence · Not medical advice