18 and older, any sex, with Diffuse Large B-Cell Lymphoma or Mantle Cell Lymphoma. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Phase 1: Number of Participants With Treatment-emergent Adverse Events (TEAEs)Primary· Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total)
A TEAE was defined as an adverse event (AE) that occurred or worsened in the period extending from the first dose of study drug to 30 days after the last dose of study drug in this study or start of a new anticancer therapy, whichever is earlier. Any clinically significant changes form baseline in safety laboratory values, vital signs, Eastern Cooperative Oncology Group (ECOG) performance status, and 12-lead electrocardiograms (ECGs) which occurred after first dose of study drug were recorded as TEAEs.
Group
Value
95% CI
Phase 1: 60 µg/kg Loncastuximab Tesirine and Ibrutinib
37
Phase 1: 75 µg/kg Loncastuximab Tesirine and Ibrutinib
4
Phase 1: 90 µg/kg Loncastuximab Tesirine and Ibrutinib
6
Phase 1: Number of Participants With Serious TEAEsPrimary· Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total)
A serious TEAE was defined as any AE which occurred after the first dose of study drug that resulted in death, was life threatening, required inpatient hospitalization or prolongation of existing hospitalization (hospitalization for elective procedures or for protocol compliance was not considered a serious adverse event), resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or important medical events that did not meet the preceding criteria but based on appropriate medical judgement may have jeopardized the participant or may have required medic
Group
Value
95% CI
Phase 1: 60 µg/kg Loncastuximab Tesirine and Ibrutinib
19
Phase 1: 75 µg/kg Loncastuximab Tesirine and Ibrutinib
0
Phase 1: 90 µg/kg Loncastuximab Tesirine and Ibrutinib
3
Phase 1: Number of Participants With Dose-Limiting Toxicities (DLTs)Primary· 21 days
A DLT was defined as any of the following events which occur during the DLT Period (first 21 days of ibrutinib treatment), except those that are clearly due to underlying disease or extraneous causes: a hematologic DLT (grade ≥3 anaemia, grade 4/febrile neutropenia, grade ≥3 thrombocytopenia), a non-hematologic DLT (including aspartate aminotransferase \[AST\] and/or alanine aminotransferase \[ALT\] \>3× upper limit of normal (ULN) and bilirubin \>2× ULN), any other non-hematologic toxicities ≥ Grade 3, with exceptions.
Group
Value
95% CI
Phase 1: 60 µg/kg Loncastuximab Tesirine and Ibrutinib
0
Phase 1: 75 µg/kg Loncastuximab Tesirine and Ibrutinib
0
Phase 1: 90 µg/kg Loncastuximab Tesirine and Ibrutinib
2
Phase 1: Number of Participants With Dose InterruptionsPrimary· Up to a maximum of 686 days
Group
Value
95% CI
Phase 1: 60 µg/kg Loncastuximab Tesirine and Ibrutinib
1
Phase 1: 75 µg/kg Loncastuximab Tesirine and Ibrutinib
0
Phase 1: 90 µg/kg Loncastuximab Tesirine and Ibrutinib
0
Phase 1: Number of Participants With Dose ReductionsPrimary· Up to a maximum of 686 days
Group
Value
95% CI
Phase 1: 60 µg/kg Loncastuximab Tesirine and Ibrutinib
0
Phase 1: 75 µg/kg Loncastuximab Tesirine and Ibrutinib
0
Phase 1: 90 µg/kg Loncastuximab Tesirine and Ibrutinib
0
Phase 2: Complete Response Rate (CRR)Primary· Up to approximately 38 months
CRR according to the 2014 Lugano classifications determined by Independent Review Committee (IRC). CRR was defined as the percentage of participants with a best overall response (BOR) of complete response (CR).
Group
Value
95% CI
Phase 2: Loncastuximab Tesirine and Ibrutinib in Non-Germinal Center B-cell (GCB) DLBCL
27.1
15.3 – 41.8
Phase 2: Loncastuximab Tesirine and Ibrutinib in GCB DLBCL
26.7
12.3 – 45.9
Phase 2: Loncastuximab Tesirine and Ibrutinib in MCL
90.0
55.5 – 99.7
Phase 1: Overall Response Rate (ORR)Secondary· Up to approximately 38 months
ORR according to the 2014 Lugano classification, defined as the percentage of participants with a BOR of CR or partial response (PR).
Group
Value
95% CI
Phase 1: 60 µg/kg Loncastuximab Tesirine and Ibrutinib
59.5
42.1 – 75.2
Phase 1: 75 µg/kg Loncastuximab Tesirine and Ibrutinib
50.0
6.8 – 93.2
Phase 1: 90 µg/kg Loncastuximab Tesirine and Ibrutinib
50.0
11.8 – 88.2
Phase 1 and Phase 2: Duration of Response (DOR)Secondary· Up to approximately 36 months
DOR was defined as the time from the first documentation of tumor response to disease progression or death.
Group
Value
95% CI
Phase 1: 60 µg/kg Loncastuximab Tesirine and Ibrutinib
7.49
2.46 – 20.50
Phase 1: 75 µg/kg Loncastuximab Tesirine and Ibrutinib
NA
NA – NA
Phase 1: 90 µg/kg Loncastuximab Tesirine and Ibrutinib
2.50
1.94 – NA
Phase 2: Loncastuximab Tesirine and Ibrutinib in Non-Germinal Center B-cell (GCB) DLBCL
8.25
2.30 – NA
Phase 2: Loncastuximab Tesirine and Ibrutinib in GCB DLBCL
7.64
1.87 – NA
Phase 2: Loncastuximab Tesirine and Ibrutinib in MCL
NA
NA – NA
Phase 1 and Phase 2: Relapse-Free Survival (RFS)Secondary· Up to approximately 36 months
RFS was defined as the time from the documentation of CR to disease progression or death.
Group
Value
95% CI
Phase 1: 60 µg/kg Loncastuximab Tesirine and Ibrutinib
7.49
3.61 – 22.28
Phase 1: 75 µg/kg Loncastuximab Tesirine and Ibrutinib
NA
NA – NA
Phase 1: 90 µg/kg Loncastuximab Tesirine and Ibrutinib
1.94
NA – NA
Phase 2: Loncastuximab Tesirine and Ibrutinib in Non-Germinal Center B-cell (GCB) DLBCL
NA
NA – NA
Phase 2: Loncastuximab Tesirine and Ibrutinib in GCB DLBCL
NA
NA – NA
Phase 2: Loncastuximab Tesirine and Ibrutinib in MCL
NA
NA – NA
Phase 1 and Phase 2: Progression-Free Survival (PFS)Secondary· Up to approximately 37 months
PFS was defined as the time between start of treatment and the first documentation of progression, or death.
Group
Value
95% CI
Phase 1: 60 µg/kg Loncastuximab Tesirine and Ibrutinib
3.55
1.74 – 7.79
Phase 1: 75 µg/kg Loncastuximab Tesirine and Ibrutinib
3.17
1.22 – NA
Phase 1: 90 µg/kg Loncastuximab Tesirine and Ibrutinib
2.12
0.69 – NA
Phase 2: Loncastuximab Tesirine and Ibrutinib in Non-Germinal Center B-cell (GCB) DLBCL
3.20
1.41 – 4.99
Phase 2: Loncastuximab Tesirine and Ibrutinib in GCB DLBCL
3.02
1.31 – 6.80
Phase 2: Loncastuximab Tesirine and Ibrutinib in MCL
NA
NA – NA
Phase 1 and Phase 2: Overall Survival (OS)Secondary· Up to approximately 38 months
OS was defined as the time between the start of treatment and death from any cause.
Group
Value
95% CI
Phase 1: 60 µg/kg Loncastuximab Tesirine and Ibrutinib
14.23
7.82 – 25.99
Phase 1: 75 µg/kg Loncastuximab Tesirine and Ibrutinib
NA
NA – NA
Phase 1: 90 µg/kg Loncastuximab Tesirine and Ibrutinib
NA
NA – NA
Phase 2: Loncastuximab Tesirine and Ibrutinib in Non-Germinal Center B-cell (GCB) DLBCL
8.54
4.57 – 20.60
Phase 2: Loncastuximab Tesirine and Ibrutinib in GCB DLBCL
16.76
7.16 – NA
Phase 2: Loncastuximab Tesirine and Ibrutinib in MCL
NA
NA – NA
Phase 1 and Phase 2: Time to Reach Maximum Concentration (Tmax) of Loncastuximab Tesirine (Total Antibody, PBD-Conjugated Antibody and Unconjugated Cytotoxin SG3199)Secondary· C1D1 pre-dose, EOI, 4h PD, C1D8 168h PD, C1D15 336h PD, C2D1 pre-dose, EOI, 4h PD, C2D8 168h PD, C2D15 336h PD (3 week cycles)
Blood samples were collected for analysis of PK data of loncastuximab tesirine (total antibody, PBD-conjugated antibody and unconjugated cytotoxin SG3199)
Cycle 1: PBD-conjugated Antibody
Group
Value
95% CI
Phase 1 and Phase 2: 60 µg/kg Loncastuximab Tesirine and Ibrutinib
0.0410
± 122
Phase 1: 75 µg/kg Loncastuximab Tesirine and Ibrutinib
0.0410
± 118
Phase 1: 90 µg/kg Loncastuximab Tesirine and Ibrutinib
0.0330
± 108
Cycle 1: Total Antibody
Group
Value
95% CI
Phase 1 and Phase 2: 60 µg/kg Loncastuximab Tesirine and Ibrutinib
0.0420
± 125
Phase 1: 75 µg/kg Loncastuximab Tesirine and Ibrutinib
0.0410
± 118
Phase 1: 90 µg/kg Loncastuximab Tesirine and Ibrutinib
0.0250
± 21.1
Cycle 1: Unconjugated cytotoxin SG3199
Group
Value
95% CI
Phase 1 and Phase 2: 60 µg/kg Loncastuximab Tesirine and Ibrutinib
14.9
± NA
Phase 1: 90 µg/kg Loncastuximab Tesirine and Ibrutinib
6.94
± NA
Cycle 2: PBD-conjugated Antibody
Group
Value
95% CI
Phase 1 and Phase 2: 60 µg/kg Loncastuximab Tesirine and Ibrutinib
0.0470
± 223
Phase 1: 75 µg/kg Loncastuximab Tesirine and Ibrutinib
0.164
± 3347
Phase 1: 90 µg/kg Loncastuximab Tesirine and Ibrutinib
0.0280
± 37.8
Cycle 2: Total Antibody
Group
Value
95% CI
Phase 1 and Phase 2: 60 µg/kg Loncastuximab Tesirine and Ibrutinib
0.0570
± 232
Phase 1: 75 µg/kg Loncastuximab Tesirine and Ibrutinib
0.0370
± 136
Phase 1: 90 µg/kg Loncastuximab Tesirine and Ibrutinib
0.0280
± 37.8
Cycle 2: Unconjugated cytotoxin SG3199
Group
Value
95% CI
Phase 1 and Phase 2: 60 µg/kg Loncastuximab Tesirine and Ibrutinib
0.0220
± 19.9
Adverse events — posted to ClinicalTrials.gov
Time frame: All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total)..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Phase 1: 60 µg/kg Loncastuximab Tesirine and Ibrutinib
Serious: 19/37 (51%)
Deaths: 24/37
Phase 1: 75 µg/kg Loncastuximab Tesirine and Ibrutinib
Serious: 0/4 (0%)
Deaths: 0/4
Phase 1: 90 µg/kg Loncastuximab Tesirine and Ibrutinib
Serious: 3/6 (50%)
Deaths: 3/6
Phase 2: Loncastuximab Tesirine and Ibrutinib in Non-Germinal Center B-cell (GCB) DLBCL
Serious: 27/49 (55%)
Deaths: 28/49
Phase 2: Loncastuximab Tesirine and Ibrutinib in GCB DLBCL
Serious: 5/30 (17%)
Deaths: 14/30
Phase 2: Loncastuximab Tesirine and Ibrutinib in MCL
Serious: 5/10 (50%)
Deaths: 3/10
Serious adverse events (66 terms)
Reaction
System
Phase 1: 60 µg/kg Loncastu…
Phase 1: 75 µg/kg Loncastu…
Phase 1: 90 µg/kg Loncastu…
Phase 2: Loncastuximab Tes…
Phase 2: Loncastuximab Tes…
Phase 2: Loncastuximab Tes…
Pneumonia viral
Infections and infestations
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General physical health deterioration
General disorders
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Neutropenia
Blood and lymphatic system disorders
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Death
General disorders
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Corona virus infection
Infections and infestations
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Sepsis
Infections and infestations
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Urinary tract infection
Infections and infestations
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Hypercalcaemia
Metabolism and nutrition disorders
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Acute kidney injury
Renal and urinary disorders
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Febrile neutropenia
Blood and lymphatic system disorders
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Lymph node pain
Blood and lymphatic system disorders
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Haemorrhagic disorder
Blood and lymphatic system disorders
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Atrial fibrillation
Cardiac disorders
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Pericardial effusion
Cardiac disorders
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Cardiomyopathy
Cardiac disorders
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Cardiopulmonary failure
Cardiac disorders
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Coronary artery disease
Cardiac disorders
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Pericardial disease
Cardiac disorders
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Pericarditis
Cardiac disorders
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Inappropriate antidiuretic hormone secretion
Endocrine disorders
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Abdominal pain upper
Gastrointestinal disorders
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Ascites
Gastrointestinal disorders
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Small intestinal obstruction
Gastrointestinal disorders
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Stomatitis
Gastrointestinal disorders
—
—
—
—
—
—
Vomiting
Gastrointestinal disorders
—
—
—
—
—
—
Other adverse events (146 terms — click to expand)
The purpose of this Phase 1/2 study is to evaluate the safety and efficacy of Loncastuximab Tesirine (ADCT-402) in combination with Ibrutinib in participants with Advanced Diffuse Large B-Cell Lymphoma or Mantle Cell Lymphoma.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT06919939 — Epcoritamab in Combination With Loncastuximab Tesirine in Relapsed/Refractory Large B-cell Lymphoma
· Phase 2
· recruiting
NCT05672251 — Loncastuximab Tesirine and Mosunetuzumab for the Treatment of Relapsed or Refractory Diffuse Large B-Cell Lymphoma
· Phase 2
· recruiting
NCT05453396 — Loncastuximab Tesirine for the Treatment of Relapsed or Refractory B-Cell Malignancies
· Phase 2
· recruiting
NCT05600686 — Loncastuximab Tesirine and Rituximab Followed by DA-EPOCH-R for Treating Patients With High-Risk Diffuse Large B-cell Ly
· Phase 2
· recruiting
NCT05464719 — A Phase II Study of Loncastuximab Tesirine as Consolidation Strategy in Patients With LBCL in PR After CAR T-cell Therap
· Phase 2
· recruiting
Other recruiting trials for Diffuse Large B-Cell Lymphoma
Currently open trials in the same condition.
NCT06863402 — Nemtabrutinib and Pembrolizumab for the Treatment of Richter Transformation, Diffuse Large B-cell Lymphoma Subtype
· Phase 2
· recruiting
NCT07200375 — An Observational Study of Glofitamab in Chinese Adult Participants With 2L Diffuse Large B-Cell Lymphoma
· recruiting
NCT07070648 — Study on Predicting Response to Standard First-Line Treatment in Diffuse Large B-Cell Lymphoma (DLBCL) Patients Using ct
· recruiting
NCT07001540 — Evaluation of the Efficacy and Safety of Polatuzumab Vedotin Combined With Rituximab, Gemcitabine, and Oxaliplatin (Pola
· Phase 2
· recruiting
NCT06803693 — Efficacy and Safety of Pola-RCHP-X vs Pola-RCHP in Untreated DLBCL
· Phase 2
· recruiting
Other ADC Therapeutics S.A. trials
Trials by the same sponsor.
NCT05389462 — A Study of Mipasetamab Uzoptirine (ADCT-601) in Participants With Solid Tumors
· Phase 1
· terminated
NCT05144009 — A Study of Loncastuximab Tesirine and Rituximab (Lonca-R) in Previously Untreated Unfit/Frail Participants With Diffuse
· Phase 2
· terminated
NCT04970901 — A Study to Evaluate the Safety and Anti-cancer Activity of Loncastuximab Tesirine in Combination With Other Anti-cancer
· Phase 1
· recruiting
NCT04974996 — A Study to Evaluate the Tolerability, Safety, Pharmacokinetics, and Antitumor Activity of Loncastuximab Tesirine in Comb
· Phase 1
· withdrawn
NCT04699461 — Study to Evaluate the Efficacy and Safety of Loncastuximab Tesirine Versus Idelalisib in Participants With Relapsed or R
· Phase 2
· terminated
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by ADC Therapeutics S.A.
Last refreshed: 6 February 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03684694.