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Clinical trial · no report yet · Phase 1/Phase 2
NCT02500407
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)
- NCT02500407 ↗
- Completed
- Genentech, Inc.
- Focused
We haven't built an HCP commentary report on NCT02500407 yet. This page shows the registry record and the public commentary we found that names the trial. A report reads that commentary and sets out what clinicians said about the trial, each point linked to its source. How reports are made.
Indexed commentary on NCT02500407 so far
Podcasts, YouTube videos and X posts we have indexed that name the trial. It is where a report starts, not where it ends: the build searches for more, so finished reports usually cover more than this.
| Channel | Indexed | |
|---|---|---|
| X threads | 4 |
The trial
ClinicalTrials.gov- Official title
- An Open-Label, Multicenter, Phase I/II Trial Evaluating the Safety, Efficacy, and Pharmacokinetics of Escalating Doses of Mosunetuzumab (BTCT4465A) as a Single Agent and Combined With Atezolizumab in Patients With Relapsed or Refractory B-Cell Non-Hodgkin's Lymphoma and Chronic Lymphocytic Leukemia
- Phase
- Phase 1/Phase 2
- Status
- Completed
- Conditions
- Lymphocytic Leukemia, Chronic; Lymphoma, Non Hodgkin
- Interventions
- BTCT4465A (Mosunetuzumab) IV; Atezolizumab; BTCT4465A (Mosunetuzumab) SC
- Arms
- Dose Escalation · Experimental
- Dose Expansion · Experimental
- Enrollment
- 713
- Primary outcomes
- Maximum Tolerated Dose (MTD) of BTCT4465A (Mosunetuzumab)
- Percentage of Participants With Adverse Events
- BTCT4465A (Mosunetuzumab) Serum Concentration
- Atezolizumab Serum Concentration
- Percentage of Participants with Complete Response as Assessed Using Standard Criteria for NHL
- Sponsor
- Genentech, Inc.
- Start
- Sep 15, 2015
- Primary completion
- May 21, 2024
- Results posted
- No
- Registry record
- NCT02500407 · updated Sep 12, 2025
Publications
linked from the registry- 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. PubMed 41862428
- 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. PubMed 41643182
- 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. PubMed 40472301
- 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. PubMed 40279333
- 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. PubMed 39571171
- 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. PubMed 39447094
- 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. PubMed 39328022
- 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. PubMed 38901633
- 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. PubMed 38843483
- 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. PubMed 38808543
- 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. PubMed 38547425
- 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. PubMed 38048694
- 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. PubMed 37981564
- 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. PubMed 37851321
- 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. PubMed 37067952
- 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. PubMed 35803286
- 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. PubMed 34914545