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Large B-cell LymphomaPhase 2NCT05464719

A Phase II Study of Loncastuximab Tesirine as Consolidation Strategy in Patients With LBCL in PR After CAR T-cell Therapy

A Phase 2 study testing Loncastuximab Tesirine in people with Large B-cell Lymphoma and Lymphoma, run by M.D. Anderson Cancer Center at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

To learn if loncastuximab tesirine (called "lonca" in this informed consent form) can help to control large B-cell lymphoma that is relapsed or refractory after receiving CAR T-cell therapy. The safety and possible effects of the study therapy will also be studied. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Large B-cell Lymphoma, Lymphoma
What is being tested?
Loncastuximab Tesirine
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteUnited States
Study dates
23 Sep 2022to 30 Jan 2030
Phase
Phase 2
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

  • Eligible subjects will be considered for inclusion in this study if they meet the following criteria:
  • Relapsed or refractory diffuse large B-cell lymphoma, primary mediastinal B-cell lymphoma, transformed indolent B-cell lymphomas and high-grade B-cell lymphoma
  • Receive standard of care treatment with an FDA-approved anti-CD19 autologous CAR T-cell product, outside of a clinical trial
  • ≥ 18 years of age
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2
  • Achievement of PR according to Lugano 2014 response criteria 30 days after CAR T-cell therapy
Show all 38Show fewer
  • At least 30 days must have elapsed since CAR T-cell therapy infusion
  • No evidence of CD19 expression after CAR T-cell therapy infusion is required for enrolment
  • No additional anti-tumoral therapy, with the exclusion of palliative radiotherapy, must have been received after CAR T-cell therapy
  • Absolute neutrophil count (ANC) of ≥ 1.0×109/L without growth factor support for 3 days prior to screening assessment.
  • Platelet count of ≥ 50×109/L without transfusion for 3 days prior to screening assessment.
  • Creatinine clearance (as estimated by Cockcroft Gault) ≥ 30 mL/min
  • Serum alanine transaminase (ALT) or aspartate transaminase (AST) ≤ 2.5 upper limit of normal (ULN)
  • Total bilirubin ≤2 mg/dL, except in subjects with Gilbert's syndrome.
  • Cardiac ejection fraction ≥ 45% with no evidence of clinically significant pericardial effusion
  • Baseline oxygen saturation > 92% on room air
  • No evidence or suspicion of lymphoma actively involving the central nervous system (CNS)
  • Females of childbearing potential must have a negative serum or urine pregnancy test (females who have undergone surgical sterilization or who have been postmenopausal for at least 2 years are not considered to be of childbearing potential)
  • Resolution of any previous CRS and/or ICANS to grade 0.
  • 4.3 Exclusion criteria
  • Subjects will be ineligible for this study if they meet the following criteria:
  • 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)
  • History of malignancy other than nonmelanoma skin cancer or carcinoma in situ (e.g. prostate, cervix, bladder, breast) unless disease free for at least 12 months
  • History of Richter's transformation of chronic lymphocytic leukemia (CLL)
  • Treatment with CAR T-cell therapy on clinical trial as immediate treatment before enrollment
  • Prior treatment with lonca
  • Presence of fungal, bacterial, viral, or other infection that is uncontrolled or requiring IV antimicrobials for management. Simple UTI and uncomplicated bacterial pharyngitis are permitted if responding to active treatment and after consultation with the Principal investigator
  • Known history of infection with HIV or hepatitis B (HBsAg positive) or hepatitis C virus (anti-HCV positive). A history of HIV, hepatitis B or hepatitis C is permitted if the viral load is undetectable per quantitative PCR and/or nucleic acid testing.
  • Subjects with active cardiac atrial or cardiac ventricular lymphoma involvement
  • History of myocardial infarction, cardiac angioplasty or stenting, unstable angina, or other clinically significant cardiac disease within 12 months of enrolment
  • Primary immunodeficiency
  • History of autoimmune disease (e.g. Crohns, rheumatoid arthritis, systemic lupus) resulting in end organ injury or requiring active systemic immunosuppression/systemic disease modifying agents within the last 2 years
  • History of clinically significant deep vein thrombosis or pulmonary embolism within 1 month of enrollment per investigators discretion.
  • Any medical condition likely to interfere with assessment of safety or efficacy of study treatment
  • History of severe immediate hypersensitivity reaction to any of the agents used in this study
  • Women of child-bearing potential who are pregnant or breastfeeding because of the potentially dangerous effects of the PBD on the fetus or infant.
  • Subjects of both genders who are not willing to practice birth control. Women of childbearing potential must use a highly effective method of contraception (hormonal birth control such as birth control pills, intravaginal ring, skin patch, implant or injection, intrauterine device or surgical sterilization) until 9 months after last dose of lonca, and men with female partners who are of childbearing potential should use a condom when sexually active until 6 months after the last dose of lonca
  • In the investigator's judgment, the subject is unlikely to complete all protocol-required study visits or procedures, including follow-up visits, or comply with the study requirements for participation Trial Treatments

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Paolo Strati, MD contact

(713) 745-1776

pstrati@mdanderson.org

United States1 site, 1 recruiting

  • MD Anderson Cancer Center

    Houston, Texas, 77030

    Paolo Strati, MD, 713-745-1776, pstrati@mdanderson.org

    Paolo Strati, MD

    Recruiting

Other trials in United States

About this study

To learn if loncastuximab tesirine (called "lonca" in this informed consent form) can help to control large B-cell lymphoma that is relapsed or refractory after receiving CAR T-cell therapy. The safety and possible effects of the study therapy will also be studied.

Read the detailed description

Primary Objective:

-To evaluate the efficacy of lonca as consolidation therapy in patients with relapsed or refractory LBCL who achieve PR after CAR T-cell therapy.

Secondary Objectives:

-To evaluate safety and tolerability of lonca as consolidation therapy in patients with relapsed or refractory LBCL who achieve PR after CAR T-cell therapy.

Exploratory Objective:

-To determine the pharmacodynamic effects and investigate biomarkers of response and resistance of this novel consolidation therapy.

Being tested
Loncastuximab Tesirine
Medical subject headings
Lymphoma

What participants receive

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

  • Loncastuximab TesirineDrug

    Also called Lonca

    Given by IV

Study groups in NCT05464719
Study groupRoleWhat they receive
Loncastuximab TesirineExperimentalParticipants will receive Loncastuximab Tesirine (lonca) by vein.
Receives: Drug: Loncastuximab Tesirine

What is being measured

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

  1. Rate of conversion to complete response

    Measured: through study completion and or average of 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 posted19 Jul 2022
  2. Study start23 Sep 2022
  3. Primary completion30 Jan 2030 (estimated)
  4. Study completion30 Jan 2030 (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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05464719
Sponsor's protocol ID
2022-0147
Other IDs
NCI-2022-05750
Status last verified
Jul 2026
First submitted
11 Jul 2022
Last updated
15 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Kuhnl A, Kirkwood AA, Northend M, Alajangi R, Uttenthal B, Norman J, Hiew H, Seymour F, Maybury BD, Osborne W, Sillito F, Abdulgawad A, Jones C, Delaney A, Townsend W, Panopoulou A, Gribben JG, Bataillard E, Mathew A, Martinez-Calle N, Gajendran L, Davies AJ, Chavda N, Kumar E, Sanderson R, Kamat S, Petrides G, Roddie C, Menne T, Chaganti S. Early PET response predicts the risk of relapse after 2L axi-cel in large B-cell lymphoma. Blood Adv. 2026 Jun 9;10(11):3777-3786. doi: 10.1182/bloodadvances.2026019802.

    PubMed 41894687

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Loncastuximab Tesirine in people with Large B-cell Lymphoma and Lymphoma, run by M.D. Anderson Cancer Center at 1 site in United States.

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 38 inclusion and 0 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: looking for participants now, as of the sponsor's last update on 15 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 1 site in United States. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Contact Paolo Strati, MD ((713) 745-1776, pstrati@mdanderson.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of conversion to complete response (time frame: through study completion and or average of 1 year). 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 NCT05464719, which also lists 1 linked publication.

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 15 Jul 2026; AzTrials last refreshed its copy on 7 Nov 2026.

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