18 and older, any sex, with Diffuse Large B-Cell Lymphoma Refractory or Diffuse Large B-cell Lymphoma Recurrent. 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.
Overall Response Rate (ORR)Primary· Up to 21.5 months
ORR, as determined by central review according to the 2014 Lugano classification, defined as the percentage of participants with a best overall response (BOR) of complete response (CR) or partial response (PR).
Group
Value
95% CI
Loncastuximab Tesirine
48.3
39.9 – 56.7
Duration of Response (DOR)Secondary· Up to 39 months
DOR defined as the time from the first documentation of tumor response to disease progression or death.
Group
Value
95% CI
Loncastuximab Tesirine
13.37
6.87 – NA
Complete Response (CR) RateSecondary· Up to 39 months
CR rate defined as the percentage of treated participants with a best overall response (BOR) of CR.
Group
Value
95% CI
Loncastuximab Tesirine
24.8
18.0 – 32.7
Relapse-free Survival (RFS)Secondary· Up to 39 months
RFS was defined as the time from the documentation of CR to disease progression or death.
Group
Value
95% CI
Loncastuximab Tesirine
NA
NA – NA
Progression-free Survival (PFS)Secondary· Up to 40 months
PFS was defined as the time between start of treatment and the first documentation of recurrence, progression, or death.
Group
Value
95% CI
Loncastuximab Tesirine
4.93
2.89 – 8.31
Overall Survival (OS)Secondary· Up to 43 months
OS was defined as the time between the start of treatment and death from any cause.
Group
Value
95% CI
Loncastuximab Tesirine
9.53
6.74 – 11.47
Number of Participants Who Experience Treatment-emergent Adverse Events (TEAEs)Secondary· Up to 599 days
An adverse event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product that did not necessarily have to have a causal relationship with treatment. A TEAE was an adverse event with an onset that began or worsened on or after the first dose date and until 30 days after the last dose date, or start of a new anticancer therapy/procedure, whichever came earlier. TEAE assessments also included those per the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 Grade ≥3 AEs and serious TEAEs.
AEs were
Any TEAE
Group
Value
95% CI
Loncastuximab Tesirine
143
Grade ≥3 TEAE
Group
Value
95% CI
Loncastuximab Tesirine
107
Serious TEAE
Group
Value
95% CI
Loncastuximab Tesirine
57
Number of Participants With Clinically Significant Changes From Baseline in Clinical Laboratory TestsSecondary· Baseline up to 599 days
Clinical laboratory tests included hematology and chemistry. Clinically significant changes were determined by the Investigator.
Group
Value
95% CI
Loncastuximab Tesirine
83
Number of Participants With Clinically Significant Change From Baseline in Vital SignsSecondary· Baseline up to 599 days
Vital sign measurements included arterial blood pressure, heart rate, respiratory rate, and body temperature. Clinical significance was determined by the investigator.
Group
Value
95% CI
Loncastuximab Tesirine
0
Eastern Cooperative Oncology Group (ECOG) Performance Status at Baseline and End of TreatmentSecondary· Baseline and end of treatment (up to 599 days)
ECOG (Eastern Cooperative Oncology Group) Performance Status is scored on a 6-point scale where higher scores indicate a worse outcome. ECOG scores include the following:
* 0 = fully active, able to carry on all pre-disease performance without restriction
* 1 = restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work
* 2 = ambulatory and capable of all self-care but unable to carry out any work activities; up and about more than 50% of waking hours
* 3 = capable of only limited self-care; confined
Baseline
Group
Value
95% CI
Loncastuximab Tesirine
58
Loncastuximab Tesirine
78
Loncastuximab Tesirine
9
Loncastuximab Tesirine
0
End of treatment
Group
Value
95% CI
Loncastuximab Tesirine
44
Loncastuximab Tesirine
50
Loncastuximab Tesirine
14
Loncastuximab Tesirine
2
Number of Participants With Clinically Significant Change From Baseline in 12-lead Electrocardiograms (ECGs)Secondary· Baseline up to 599 days
Clinically significant changes from baseline for 12-lead ECGs were measured as abnormal QT interval corrected by Fridericia formula (QTcF) and QT interval corrected by Bazett formula (QTcB) values.
QTcB maximum change from baseline: >30, <=60 msec
Group
Value
95% CI
Loncastuximab Tesirine
30
QTcB maximum change from baseline: >60 msec
Group
Value
95% CI
Loncastuximab Tesirine
4
QTcF maximum change from baseline: >30, <=60 msec
Group
Value
95% CI
Loncastuximab Tesirine
23
QTcF maximum change from baseline: >60 msec
Group
Value
95% CI
Loncastuximab Tesirine
1
Maximum Concentration (Cmax) of Loncastuximab Tesirine Conjugated Antibody, Total Antibody and Warhead SG3199Secondary· Cycles 1 and 2: Day 1 pre-dose, and at 0, 4, 168 and 336 hours post-dose; Cycle 3: Day 1 pre-dose and end of infusion
Conjugated Antibody Cycle 1
Group
Value
95% CI
Loncastuximab Tesirine
2430
± 38.8
Conjugated Antibody Cycle 2
Group
Value
95% CI
Loncastuximab Tesirine
2734
± 35.8
Conjugated Antibody Cycle 3
Group
Value
95% CI
Loncastuximab Tesirine
1694
± 47.6
Total Antibody Cycle 1
Group
Value
95% CI
Loncastuximab Tesirine
3267
± 36.7
Total Antibody Cycle 2
Group
Value
95% CI
Loncastuximab Tesirine
3756
± 31.3
Total Antibody Cycle 3
Group
Value
95% CI
Loncastuximab Tesirine
2581
± 41.9
SG3199 Cycle 1
Group
Value
95% CI
Loncastuximab Tesirine
0.0410
± 56.6
SG3199 Cycle 2
Group
Value
95% CI
Loncastuximab Tesirine
0.0490
± 78.8
Adverse events — posted to ClinicalTrials.gov
Time frame: Up to 43 months.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
The purpose of this Phase 2 study is to evaluate the clinical efficacy and safety of Loncastuximab Tesirine (ADCT-402) in patients with relapsed or refractory Diffuse Large B-Cell Lymphoma.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT05991388 — A Global Study of Novel Agents in Paediatric and Adolescent Relapsed and Refractory B-cell Non-Hodgkin Lymphoma
· Phase 2, PHASE3
· recruiting
NCT04998669 — Loncastuximab Tesirine in Combination With Rituximab in Patients With Relapsed or Refractory Follicular Lymphoma
· Phase 2
· recruiting
NCT04974996 — A Study to Evaluate the Tolerability, Safety, Pharmacokinetics, and Antitumor Activity of Loncastuximab Tesirine in Comb
· Phase 1
· withdrawn
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: 29 August 2023
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/NCT03589469.