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B-Cell Non-Hodgkin LymphomaPhase 1NCT04970901

A Study to Evaluate the Safety and Anti-cancer Activity of Loncastuximab Tesirine in Combination With Other Anti-cancer Agents in Participants With Relapsed or Refractory B-cell Non-Hodgkin Lymphoma (LOTIS-7)

A Phase 1 study testing Loncastuximab Tesirine, Polatuzumab Vedotin and Glofitamab in people with B-Cell Non-Hodgkin Lymphoma and Relapsed B-Cell Non-Hodgkin Lymphoma, run by ADC Therapeutics S.A. at 40 sites in 6 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

The primary objective of this study is to characterize the safety and tolerability of loncastuximab tesirine in combination with polatuzumab vedotin, glofitamab, or mosunetuzumab, and to identify the maximum tolerated dose (MTD) and/or recommended dose for expansion (RDE) for the combinations. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Loncastuximab Tesirine, Polatuzumab Vedotin and Glofitamab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
154 participants
Where
40 sitesin 6 countries
Study dates
17 Jun 2022to 30 Apr 2028
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or female participant aged 18 years or older
  • Pathologic diagnosis of relapsed (disease that has recurred following a response) or refractory (disease that failed to respond to prior therapy) B-NHL (2016 World Health Organization classification) who have failed, or been intolerant to any approved therapy and had received at least two systemic treatment regimens in Part 1; and at least one systemic treatment regimen in Part 2
  • LBCL:
  • Part 2 Arm E enrollment focused on LBCL only
  • DLBCL, not otherwise specified (NOS)
  • Germinal Center B-cell type
Show all 28Show fewer
  • Activated B-cell type
  • Transformed FL (note: patients with transformed FL must have received at least one line of systemic therapy post-transformation to be eligible)
  • HGBCL, with MYC and BCL2 and/or BCL6 rearrangements
  • HGBCL, NOS
  • FL Grade 3b
  • Arm F and Part 1 Arm E:
  • All LBCL histologies listed above
  • FL (Grade 1-3a)
  • MZL
  • For Arm C only:
  • All histologies listed above
  • DLBCL (including transformed diseases)
  • MCL
  • BL
  • Life expectancy of at least 24 weeks according to Investigator's judgement
  • Need of systemic treatment for any of the listed indications as assessed by the investigator, including indolent B-NHLs (e.g. FL and MZL)
  • Measurable disease as defined by the 2014 Lugano Classification
  • Availability of formalin-fixed paraffin-embedded tumor tissue block
  • ECOG performance status 0 to 2
  • Adequate organ function
  • Women of childbearing potential (WOCBP) must agree to use a highly effective method of contraception from the time of giving informed consent until at least 10 months after the last dose of loncastuximab tesirine. Men with female partners who are of childbearing potential must agree to use a condom when sexually active or practice total abstinence from the time of giving informed consent the first dose until at least 7 months after the last dose of loncastuximab tesirine. Men must refrain from donating sperm during this same period. Arm E: WOCBP must agree to use contraceptive methods that result in a failure of less than 1% per year or remain abstinent (refrain from heterosexual intercourse) during the treatment period and for at least 18 months after pretreatment with obinutuzumab. Arm F: WOCBP must agree to use contraceptive methods that result in a failure of less than 1% per year or remain abstinent (refrain from heterosexual intercourse) during the treatment period and for at least 3 months after the final dose of mosunetuzumab and tocilizumab (if applicable)
  • Patients 80 years of age and older at the time of signing the informed consent must be deemed fit by Cumulative Illness Rating Scale - Geriatric (CIRS-G scale), defined as no score of 3-4 in any category AND < 5 categories with a score of 2 excluding hematologic criteria

Who cannot join

  • Known history of hypersensitivity resulting in treatment discontinuation to or positive serum human ADA to a CD19 antibody
  • Previous therapy with loncastuximab tesirine
  • Previous treatment with polatuzumab vedotin, glofitamab or mosunetuzumab (applied to relevant arm and/or cohort of the specific drug administered)
  • Participants who received previous treatment of polatuzumab vedotin containing regimen will be excluded from Arm C
  • Participants who received previous treatment of glofitamab containing regimen will be excluded from Arm E
  • Participants who received previous treatment of mosunetuzumab containing regimen will be excluded from Arm F
Show all 32Show fewer
  • Human immunodeficiency virus (HIV) seropositive
  • Serologic evidence of chronic hepatitis B virus (HBV) infection and unable or unwilling to receive standard prophylactic antiviral therapy or with detectable HBV viral load
  • Serologic evidence of hepatitis C virus (HCV) infection without completion of curative treatment or with detectable HCV viral load
  • History of confirmed progressive multifocal leukoencephalopathy
  • History of Stevens-Johnson syndrome, toxic epidermal necrolysis, or macrophage activation syndrome (MAS)/hemophagocytic lymphohistiocytosis (HLH)/immune effector cell associated HLH-like syndrome (IEC-HS)
  • Existing pericardial effusion (any grade) or clinically significant third space fluid accumulation (i.e., ascites requiring drainage or pleural effusion that is either requiring drainage or associated with shortness of breath)
  • Breastfeeding or pregnant
  • Significant medical comorbidities
  • Major surgery, radiotherapy, chemotherapy, or other anti-neoplastic therapy, within 14 days prior to start of study drugs (C1 D1), unless approved by the Sponsor
  • Live vaccine within 4 weeks prior to C1D1
  • Failure to recover to Grade ≤1 (Common Terminology Criteria for Adverse Events [CTCAE] version 5.0) from acute non-hematologic toxicity (excluding alopecia) due to previous therapy prior to screening
  • Active second primary malignancy other than non-melanoma skin cancers, non-metastatic prostate cancer, in situ cervical cancer, ductal or lobular carcinoma in situ of the breast, or other malignancy that the Sponsor's medical monitor and Investigator agree and document should not be exclusionary
  • Extra Exclusion Criteria for Arms E (includes glofitamab) and F (includes mosunetuzumab) Note: as applicable, the arm-specific exclusion criteria may supersede the general ones, such as stem cell transplant.
  • Prior allogeneic stem cell transplant and solid organ transplant
  • Autologous stem cell transplant within 100 days prior to C1D1
  • History of central nervous system (CNS) lymphoma or leptomeningeal infiltration
  • Current or history of CNS disease, such as stroke, epilepsy, CNS vasculitis, or neurodegenerative disease
  • Known active infection, reactivation of a latent infection, whether bacterial, viral, fungal, mycobacterial, or other pathogens (excluding fungal infections of nail beds), or any major episode of infection requiring hospitalization or treatment with intravenous (IV) antibiotics within four weeks prior to C1D1
  • Active or history of autoimmune disease or immune deficiency, motor neuropathy considered of autoimmune origin and other CNS autoimmune diseases, including but not limited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid antibody syndrome, Wegener granulomatosis, Sjögren syndrome, Guillain-Barré syndrome, or multiple sclerosis, with, with certain exceptions
  • Prior treatment with anti-cancer/lymphoma targeted therapies (e.g., tyrosine kinase inhibitors, systemic immunotherapeutic/immunostimulating agents, including, but not limited to, cluster of differentiation 137 agonists or immune checkpoint blockade therapies, including anti-cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4), anti-programmed cell death protein 1 (PD1), and anti-programmed death ligand 1 (PDL1) therapeutic antibodies, radio-immunoconjugates, ADCs, immune/cytokines and monoclonal antibodies) or treatment with systemic immunosuppressive medication (including, but not limited to, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor agents) within 4 weeks or five half-lives of the drug, whichever is shorter, prior to C1D1, or anticipation of need for systemic immunosuppressive medication during study treatment, with certain exceptions
  • Prior treatment with CAR-T-cell therapy within 100 days prior to C1D1; primary refractory patients (progressive or persistent disease within 30 days) to CAR-T-cell therapy are not eligible
  • Toxicities from prior anti-cancer therapy including immunotherapy that did not resolve to ≤ Grade 1 with the exception of alopecia, endocrinopathy managed with replacement therapy and stable vitiligo
  • Any history of immune-related Grade ≥3 AE with the exception of endocrinopathy managed with replacement therapy
  • Ongoing corticosteroid use greater than 25 mg/day of prednisone or equivalent within 4 weeks prior and during study treatment
  • Administration of a live attenuated vaccine within 4 weeks prior to the first dose of study treatment or anticipation that such a live attenuated vaccine will be required during the study or within 5 months after last dose of study treatment
  • Arm E only: Known history of hypersensitivity to obinutuzumab

Trial locations and contacts

40 sites in 6 countries.

40 sites in 6 countries

United States24 sites

  • Winship Cancer Institute of Emory University

    Atlanta, Georgia, 30322

  • The Blood and Marrow Transplant Group of Georgia

    Atlanta, Georgia, 30342

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215

  • Hollings Cancer Center

    Charleston, South Carolina, 29425

  • Emily Couric Clinical Cancer Center

    Charlottesville, Virginia, 22903

  • Cleveland Clinic Main Campus

    Cleveland, Ohio, 44195

  • University of California San Francisco - Fresno Center for Medical Education and Research

    Clovis, California, 93611

  • Baylor University Medical Center

    Dallas, Texas, 75246

  • Mission Cancer + Blood - Mission Cancer Foundation

    Des Moines, Iowa, 50309

  • NEXT Virginia (Virginia Cancer Specialists)

    Fairfax, Virginia, 22031

  • Sylvester Comprehensive Cancer Center

    Miami, Florida, 33136

  • Miami Cancer Institute

    Miami, Florida, 33176

  • Froedtert & Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • University of Minnesota

    Minneapolis, Minnesota, 55455

  • Greco-Hainsworth Tennessee Oncology Centers for Research (GHCR)

    Nashville, Tennessee, 37203

  • Columbia University Irving Medical Center

    New York, New York, 10027

  • Memorial Cancer Institute - Memorial Hospital West

    Pembroke Pines, Florida, 33028

  • Penn Medicine - Perelman Center for Advanced Medicine

    Philadelphia, Pennsylvania, 19104

  • Allegheny Health Network - West Penn Hospital

    Pittsburgh, Pennsylvania, 15224

  • Oregon Health and Science University

    Portland, Oregon, 97239

  • Brown University Health - Rhode Island Hospital

    Providence, Rhode Island, 02903

  • Huntsman Cancer Institute

    Salt Lake City, Utah, 84112

  • Scripps Health - Prebys Cancer Center

    San Diego, California, 92103

Other trials in United States

Spain5 sites

  • Institut Català d'Oncologia - Hospital Duran i Reynals (ICO L'Hospitalet)

    Barcelona, 08908

  • Hospital General Universitario Gregorio Marañón

    Madrid, 28007

  • Hospital Universitario Ramón y Cajal

    Madrid, 28034

  • Complejo Asistencial Universitario de Salamanca - Hospital Clínico

    Salamanca, 37007

  • Hospital Universitari i Politècnic La Fe

    Valencia, 46026

Other trials in Spain

Italy4 sites

  • Azienda Socio Sanitaria Territoriale (ASST) Papa Giovanni XXIII

    Bergamo, 24127

  • Centro di Ricerche Cliniche - IRCCS Azienda Ospedaliero Universitaria di Bologna

    Bologna, 40138

  • Azienda Socio Sanitaria Territoriale (ASST) degli Spedali Civili di Brescia

    Brescia, 25123

  • Istituto Europeo di Oncologia

    Milan, 20141

Other trials in Italy

Czechia3 sites

  • Fakultni nemocnice Ostrava

    Ostrava, 708 52

  • Fakultní Nemocnice Královské Vinohrady

    Prague, 100 34

  • Fakultni nemocnice v Motole

    Prague, 150 06

Other trials in Czechia

Belgium2 sites

  • Universitair Ziekenhuis Gent

    Ghent, 9000

  • Centre Hospitalier Universitaire Universite Catholique de Louvain - Site Godinne

    Yvoir, B-5530

Other trials in Belgium

United Kingdom2 sites

  • University College London Hospitals NHS Foundation Trust

    London, NW1 2PG

  • Oxford University Hospitals NHS Foundation Trust

    Oxford, OX3 7LE

Other trials in United Kingdom

About this study

Official title: A Phase 1b Open-Label Study to Evaluate the Safety and Anti-cancer Activity of Loncastuximab Tesirine in Combination With Other Anti-cancer Agents in Patients With Relapsed or Refractory B-cell Non-Hodgkin Lymphoma (LOTIS-7)

The primary objective of this study is to characterize the safety and tolerability of loncastuximab tesirine in combination with polatuzumab vedotin, glofitamab, or mosunetuzumab, and to identify the maximum tolerated dose (MTD) and/or recommended dose for expansion (RDE) for the combinations.

Read the detailed description

This is a Phase 1b, multi-center, open-label, multi-arm study to evaluate the safety and anti-cancer activity of loncastuximab tesirine in combination with polatuzumab vedotin, glofitamab, or mosunetuzumab in participants with relapsed or refractory B-cell Non-Hodgkin Lymphoma (R/R B-NHL).

Loncastuximab tesirine (ADCT-402; Zynlonta) is an antibody drug conjugate (ADC), composed of a humanized monoclonal antibody directed against human cluster of differentiation 19 (CD19) conjugated through a cathepsin-cleavable linker to a pyrrolobenzodiazepine (PBD) dimer cytotoxin. Loncastuximab tesirine has been granted by Food and Drug Administration (FDA) as accelerated approval for adult participants with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, DLBCL arising from low grade lymphoma, and high-grade B-cell lymphoma (HGBCL). In the European Union (EU), the European Commission (EC) granted conditional approval for the treatment of adult patients with relapsed or refractory DLBCL and HGBCL, after two or more lines of systemic therapy.

The study includes multiple arms in two parts, Dose Escalation part (Part 1) and Dose Expansion part (Part 2). In Part 1, for the arm of loncastuximab tesirine in combination with polatuzumab vedotin includes DLBCL, HGBCL, follicular lymphoma (FL), mantle cell lymphoma (MCL), marginal zone lymphoma (MZL), and Burkitt lymphoma (BL); for the arms of loncastuximab tesirine in combination with glofitamab or mosunetuzumab include DLBCL, HGBCL, FL, and MZL. In Part 2, participants will be treated at the dose level(s) determined from Part 1. The Sponsor will conduct the safety monitoring and the overall supervision of the study in consultation with the Dose-Escalation Steering Committee (DESC)/Data Safety Monitoring Committee (DSMC).

For each participant, the study will include a Screening Period (of up to 28 days), a Treatment Period (cycles of 21 days), and a Follow-up Period (approximately every 12 week visits for up to two years for Arm C and three years for Arms E and F). Participants may continue treatment for up to one year or until disease progression, unacceptable toxicity, or other discontinuation criteria, whichever occurs first.

Treatment with gemcitabine (Arm A), lenalidomide (Arm B), and umbralisib (Arm D) were removed.

Being tested
Loncastuximab Tesirine, Polatuzumab Vedotin, Glofitamab, Mosunetuzumab, Obinutuzumab
Keywords
B-Cell Non-Hodgkin Lymphoma, Relapsed B-Cell Non-Hodgkin Lymphoma, Refractory B-Cell Non-Hodgkin Lymphoma, Loncastuximab Tesirine
Medical subject headings
Lymphoma, B-Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Loncastuximab TesirineDrug

    Also called ZYNLONTA, ADCT-402

    Intravenous (IV) infusion

  • Polatuzumab VedotinDrug

    IV infusion

  • GlofitamabDrug

    IV infusion

  • MosunetuzumabDrug

    Subcutaneous (SC) injection

  • ObinutuzumabDrug

    IV infusion

Study groups in NCT04970901
Study groupRoleWhat they receive
Part 1 (Dose Escalation): Loncastuximab Tesirine + Polatuzumab Vedotin (Arm C)ExperimentalParticipants will receive escalating doses (90 µg/kg to 150 µg/kg) of loncastuximab tesirine on Day (D) 1 of each cycle (where each cycle is 21 days). Participants will also receive polatuzumab vedotin at a dose of 1.8 mg/kg on D1 of each cycle, infusion will be started one hour after end of loncastuximab tesirine infusion.
Receives: Drug: Loncastuximab Tesirine; Drug: Polatuzumab Vedotin
Part 1 (Dose Escalation): Loncastuximab Tesirine + Glofitamab (Arm E)ExperimentalParticipants will receive escalating doses (90 µg/kg to 150 µg/kg) of loncastuximab tesirine on D2 of Cycle (C) 1 and then D1 of all other cycles (where each cycle is 21 days). Participants will also receive glofitamab 2.5 mg on C1 D8, 10 mg on C1 D15 and 30 mg for cycles 2-12 D1. In addition participants will receive obinutuzumab pre-treatment 1000 mg on C1 D1.
Receives: Drug: Loncastuximab Tesirine; Drug: Glofitamab; Drug: Obinutuzumab
Part 1 (Dose Escalation): Loncastuximab Tesirine + Mosunetuzumab (Arm F)ExperimentalParticipants will receive escalating doses (90 µg/kg to 150 µg/kg) of loncastuximab tesirine on Day (D) 1 of each cycle (where each cycle is 21 days). Participants will also receive mosunetuzumab 5 mg on C1 D1, 45 mg for C1 D8, C1 D15 and cycles 2-8 D1.
Receives: Drug: Loncastuximab Tesirine; Drug: Mosunetuzumab
Part 2 (Dose Expansion): Loncastuximab Tesirine + Polatuzumab Vedotin (Arm C)ExperimentalParticipants with B-NHL will receive loncastuximab tesirine in combination with polatuzumab vedotin at the maximum tolerated dose (MTD) and/or recommended dose for expansion (RDE) if favorable results of Part 1 are received.
Receives: Drug: Loncastuximab Tesirine; Drug: Polatuzumab Vedotin
Part 2 (Dose Expansion): Loncastuximab Tesirine + Glofitamab (Arm E)ExperimentalParticipants with B-NHL will receive loncastuximab tesirine in combination with glofitamab at the MTD and/or RDE if favorable results of Part 1 are received. In addition participants will receive obinutuzumab pre-treatment 1000 mg on C1 D1.
Receives: Drug: Loncastuximab Tesirine; Drug: Glofitamab; Drug: Obinutuzumab
Part 2 (Dose Expansion): Loncastuximab Tesirine + Mosunetuzumab (Arm F)ExperimentalParticipants with B-NHL will receive loncastuximab tesirine in combination with mosunetuzumab at the MTD and/or RDE if favorable results of Part 1 are received.
Receives: Drug: Loncastuximab Tesirine; Drug: Mosunetuzumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants Who Experience a Dose-Limiting Toxicity (DLT)

    Measured: Day 1 to Day 21 of Cycle 1, where a cycle is 21 days

  2. Number of Participants Who Experience a Treatment-emergent Adverse Event (TEAE)

    Frequency and severity of TEAEs and treatment-emergent serious adverse events (TESAEs). TEAEs and TESAEs will be graded according to Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0.

    Measured: Up to approximately 2 years for Arm C and 3 years for Arms E and F

  3. Number of Participants Who Experience an Adverse Event (AE) Leading to Dose Delay

    Measured: Up to approximately 1 year

  4. Number of Participants Who Experience an Adverse Event (AE) Leading to Dose Interruption

    Measured: Up to approximately 1 year

  5. Number of Participants Who Experience an Adverse Event (AE) Leading to Dose Reduction

    Measured: Up to approximately 1 year

  6. Number of Participants Who Experience a Clinically Significant Change from Baseline in Safety Laboratory Measurements

    Measured: Baseline up to approximately 1 year

  7. Number of Participants Who Experience a Clinically Significant Change from Baseline in Vital Signs

    Measured: Baseline up to approximately 1 year

  8. Number of Participants Who Experience a Clinically Significant Change from Baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status

    ECOG performance status will be measured on a scale from grades 0-5, where a higher grade indicates a worse outcome.

    Measured: Baseline up to approximately 1 year

  9. Number of Participants Who Experience a Clinically Significant Change from Baseline in 12-Lead Electrocardiogram (ECG) Measurements

    Measured: Baseline up to approximately 1 year

Secondary outcomes (19)

  1. Complete Response Rate (CRR)

    Measured: Up to approximately 2 years for Arm C and 3 years for Arms E and F

  2. Overall Response Rate (ORR)

    Measured: Up to approximately 2 years for Arm C and 3 years for Arms E and F

  3. Duration of Response (DOR)

    Measured: Up to approximately 2 years for Arm C and 3 years for Arms E and F

  4. Progression-Free Survival (PFS)

    Measured: Up to approximately 2 years for Arm C and 3 years for Arms E and F

  5. Relapse-Free Survival (RFS)

    Measured: Up to approximately 2 years for Arm C and 3 years for Arms E and F

  6. Overall Survival (OS)

    Measured: Up to approximately 2 years for Arm C and 3 years for Arms E and F

  7. Average Concentration of Loncastuximab Tesirine

    Measured: Day 1 to end of treatment (up to approximately 1 year)

  8. Maximum Concentration (Cmax) of Loncastuximab Tesirine

    Measured: Day 1 to end of treatment (up to approximately 1 year)

  9. Time to Maximum Concentration (Tmax) of Loncastuximab Tesirine

    Measured: Day 1 to end of treatment (up to approximately 1 year)

  10. Area Under the Concentration-Time Curve from Time Zero to the Last Quantifiable Concentration (AUClast) of Loncastuximab Tesirine

    Measured: Day 1 to end of treatment (up to approximately 1 year)

  11. Area Under the Concentration-Time Curve from Time Zero to the End of the Dosing Interval (AUCtau) of Loncastuximab Tesirine

    Measured: Day 1 to end of treatment (up to approximately 1 year)

  12. Area Under the Concentration-Time Curve from Time Zero to Infinity (AUCinf) of Loncastuximab Tesirine

    Measured: Day 1 to end of treatment (up to approximately 1 year)

  13. Apparent Terminal Elimination Half-Life (Thalf) of Loncastuximab Tesirine

    Measured: Day 1 to end of treatment (up to approximately 1 year)

  14. Apparent Clearance (CL) of Loncastuximab Tesirine

    Measured: Day 1 to end of treatment (up to approximately 1 year)

  15. Apparent Steady-State Volume of Distribution (Vss) of Loncastuximab Tesirine

    Measured: Day 1 to end of treatment (up to approximately 1 year)

  16. Accumulation Index (AI) of Loncastuximab Tesirine

    Measured: Day 1 to end of treatment (up to approximately 1 year)

  17. Number of Participants With Anti-Drug Antibody (ADA) Titers to Loncastuximab Tesirine

    Measured: Day 1 to end of treatment (up to approximately 1 year)

  18. Arm E Only: Number of Participants With ADA Titers to Glofitamab

    Measured: Day 1 to end of treatment (up to approximately 1 year)

  19. Arm F Only: Number of Participants With ADA Titers to Mosunetuzumab

    Measured: Day 1 to end of treatment (up to approximately 1 year)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Jul 2021
  2. Study start17 Jun 2022
  3. Primary completion31 Mar 2027 (estimated)
  4. Study completion30 Apr 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
154 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04970901
Sponsor's protocol ID
ADCT-402-105
Other IDs
2021-001071-16
Status last verified
Jul 2026
First submitted
12 Jul 2021
Last updated
17 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Loncastuximab Tesirine, Polatuzumab Vedotin and Glofitamab in people with B-Cell Non-Hodgkin Lymphoma and Relapsed B-Cell Non-Hodgkin Lymphoma, run by ADC Therapeutics S.A. at 40 sites in 6 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 28 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 17 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 40 sites in United States, Spain, Italy, Czechia, Belgium and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants Who Experience a Dose-Limiting Toxicity (DLT) (time frame: Day 1 to Day 21 of Cycle 1, where a cycle is 21 days). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04970901.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2026.

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