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BTCT4465A

Phase 1

Lymphocytic Leukemia, Chronic | Small molecule | Oncology |Roche Holding AG|Last Updated: Sep 12, 2025

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment713

FDA Designations

No designations recorded

Clinical trial landscape

BTCT4465A · 1 trial · 2 indications

Phase 1 1
NCT02500407A 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)Lymphocytic Leukemia, Chronic
COMPLETED713 Analytics
PHASE1COMPLETED
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)
Lymphocytic Leukemia, Chronic
NCT02500407713
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Study Endpoints

Primary Endpoints

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)

Secondary Endpoints

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
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)
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Dose EscalationEXPERIMENTALParticipants 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 ExpansionEXPERIMENTALParticipants will receive BTCT4465A (Mosunetuzumab) as a single-agent or in combination with atezolizumab.

Interventions

NameTypeDescription
BTCT4465A (Mosunetuzumab) IVDRUGParticipants with B-cell NHL and CLL will receive BTCT4465A (Mosunetuzumab) via IV infusion.
AtezolizumabDRUGParticipants assigned to an atezolizumab combination group will receive atezolizumab 1200 mg administered as an IV infusion in combination with BTCT4465A (Mosunetuzumab).
BTCT4465A (Mosunetuzumab) SCDRUGParticipants with B-cell NHL and CLL will receive BTCT4465A (Mosunetuzumab) via SC injection.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites35

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 t...

Countries:United StatesAustraliaCanadaGermanySouth KoreaSpainUnited Kingdom
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Frequently asked questions about BTCT4465A

What is BTCT4465A used for?

BTCT4465A is an investigational small molecule being studied for chronic lymphocytic leukemia (CLL) and non-Hodgkin's lymphoma (NHL). It is in Phase 1 clinical development and is not yet approved by regulatory authorities.

Who makes BTCT4465A?

BTCT4465A is being developed by Roche Holding AG, which trades under the ticker RHHBY. The drug is currently in Phase 1 clinical development for chronic lymphocytic leukemia and non-Hodgkin's lymphoma.

What phase is BTCT4465A in?

BTCT4465A is in Phase 1 clinical development. It is an investigational drug being studied for chronic lymphocytic leukemia and non-Hodgkin's lymphoma, and it has not been approved by regulatory authorities.

What clinical trials is BTCT4465A in?

BTCT4465A has one completed Phase 1 clinical trial, NCT02500407, which enrolled 713 participants. The study evaluated BTCT4465A as a single agent and combined with atezolizumab in patients with non-Hodgkin's lymphoma and chronic lymphocytic leukemia.

Is BTCT4465A the same as mosunetuzumab?

Yes, BTCT4465A is also known as mosunetuzumab. The clinical trial NCT02500407 refers to the drug as BTCT4465A (Mosunetuzumab) in its title, indicating the two names refer to the same investigational agent.