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Loncastuximab Tesirine and Acalabrutinib

Phase 1

Chronic Lymphocytic Leukemia | Small molecule | Oncology |ADC Therapeutics SA|Last Updated: Oct 1, 2025

Target and mechanism

ModalitySmall molecule

Also known as Loncastuximab Tesirine, Loncastuximab tesirine, Loncastuximab tesirine and rituximab (Lonca-R), Loncastuximab tesirine and rituximab

Success Probability

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Market & Valuation

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Trial Design

CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment24

FDA Designations

No designations recorded

Clinical trial landscape

Loncastuximab Tesirine and Acalabrutinib · 1 trial · 1 indication

Phase 1 1
NCT05971251Addition of Loncastuximab Tesirine to Acalbrutinib , Chronic Lymphocytic LeukemiaChronic Lymphocytic Leukemia
ACTIVE NOT_RECRUITING24 Analytics
PHASE1ACTIVE NOT_RECRUITING
Addition of Loncastuximab Tesirine to Acalbrutinib , Chronic Lymphocytic Leukemia
Chronic Lymphocytic LeukemiaUnlock trial analytics

Study Endpoints

Primary Endpoints

Primary Objective
12 months

Recommended phase 2 dose of loncastuximab tesirine in combination with acalabrutinib

Secondary Endpoints

Secondary Objective 1
6 months
Secondary Objective 2
12 months
Secondary Objective 3
12 months
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Dose Level 1:EXPERIMENTAL45 µg/kg Loncastuximab Tesirine every 21 days + Acalabrutinib 100 mg BID for 12 cycles
Dose Level 2EXPERIMENTAL60 µg/kg Loncastuximab Tesirine every 21 days + Acalabrutinib 100 mg BID for 12 cycles
Dose Level 3EXPERIMENTAL75 µg/kg Loncastuximab Tesirine every 21 days + Acalabrutinib 100 mg BID for 12 cycles
Dose level 4:EXPERIMENTAL90 µg /kg Loncastuximab Tesirine (for first 2 cycles followed by 75µg/kg for subsequent 10 cycles) + Acalabrutinib 100 mg BID for a total of 12 cycles.

Interventions

NameTypeDescription
Loncastuximab Tesirine and AcalabrutinibDRUGWill be given on Day 1 of each cycle with each cycle being 21 days, and is being added to BID Acalabrutinib
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: \- Inclusion Criteria For all patients 1. Diagnosis of CLL according to the IwCLL criteria or SLL according to the World Health Organization (WHO) criteria. This includes previous documentation of: * Biopsy-proven small lymphocytic lymphoma OR * Diagnosis of CLL accordin...

Countries:United States
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Frequently asked questions about Loncastuximab Tesirine and Acalabrutinib

What is Loncastuximab Tesirine used for?

Loncastuximab Tesirine is an investigational oncology drug being studied for post-transplant lymphoproliferative disorder, B-cell non-Hodgkin lymphoma, refractory diffuse large B-cell lymphoma, central nervous system lymphoma, and relapsed diffuse large B-cell lymphoma. It is in Phase 1 clinical development and is not FDA approved.

Who makes Loncastuximab Tesirine?

Loncastuximab Tesirine is developed by ADC Therapeutics SA, traded on the New York Stock Exchange under the ticker ADCT. The company is conducting clinical trials to evaluate the drug's safety and efficacy in various B-cell malignancies.

What phase is Loncastuximab Tesirine in?

Loncastuximab Tesirine is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by the FDA. The drug is being studied in combination with other anti-cancer agents for relapsed or refractory B-cell non-Hodgkin lymphoma.

What clinical trials is Loncastuximab Tesirine in?

Loncastuximab Tesirine is being evaluated in several trials, including NCT03589469 (completed Phase 2 in relapsed/refractory DLBCL), NCT04970901 (recruiting Phase 1 LOTIS-7 in B-cell NHL), NCT06788964 (recruiting Phase 2 CORAL bridging therapy), and NCT07573436 (not yet recruiting Phase 1 PLUTO in post-transplant lymphoproliferative disorder).

Is Loncastuximab Tesirine the same as Loncastuximab Tesirine and Acalabrutinib?

Loncastuximab Tesirine is also known as Loncastuximab Tesirine and Acalabrutinib, Loncastuximab tesirine and rituximab (Lonca-R), and Loncastuximab tesirine and rituximab. These names refer to the drug in combination with other agents, while Loncastuximab Tesirine alone is the single-agent form.

What does Loncastuximab Tesirine target?

Loncastuximab Tesirine is a small molecule oncology drug. The specific molecular target is not disclosed in the available information, but it is being studied in B-cell malignancies including diffuse large B-cell lymphoma and post-transplant lymphoproliferative disorder.