Clinical trial · Interventional
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 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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymphocytic Leukemia, Chronic | Chronic Lymphocytic Leukemia | ONTOLOGY_EXACT | 0.98 |
| Lymphoma, Non Hodgkin | Non-Hodgkin Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Atezolizumab | Drug | Atezolizumab | ALIAS |
| BTCT4465A (Mosunetuzumab) IV | Drug | Mosunetuzumab | ALIAS |
| BTCT4465A (Mosunetuzumab) SC | Drug | Mosunetuzumab | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Dose Escalation
- 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.
- interventionNames
- Drug: BTCT4465A (Mosunetuzumab) IV
- Drug: Atezolizumab
- Drug: BTCT4465A (Mosunetuzumab) SC
- type
- EXPERIMENTAL
- label
- Dose Expansion
- description
- Participants will receive BTCT4465A (Mosunetuzumab) as a single-agent or in combination with atezolizumab.
- interventionNames
- Drug: BTCT4465A (Mosunetuzumab) IV
- Drug: Atezolizumab
- Drug: BTCT4465A (Mosunetuzumab) SC
Primary outcomes (5)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (17)
- DERIVEDBartlett 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
- DERIVEDLewis 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. PMID 41643182
- DERIVEDDanilov 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. PMID 40472301
- DERIVEDLi 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
- DERIVEDChong 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