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

RECRUITINGPHASE2

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

NCT05464719•M.D. Anderson Cancer Center

View on ClinicalTrials.gov

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.

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Eligible subjects will be considered for inclusion in this study if they meet the following criteria:
•1. Relapsed or refractory diffuse large B-cell lymphoma, primary mediastinal B-cell lymphoma, transformed indolent B-cell lymphomas and high-grade B-cell lymphoma
•2. Receive standard of care treatment with an FDA-approved anti-CD19 autologous CAR T-cell product, outside of a clinical trial
•3. ≥ 18 years of age
•4. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2
•5. Achievement of PR according to Lugano 2014 response criteria 30 days after CAR T-cell therapy
•6. At least 30 days must have elapsed since CAR T-cell therapy infusion
•7. No evidence of CD19 expression after CAR T-cell therapy infusion is required for enrolment
•8. No additional anti-tumoral therapy, with the exclusion of palliative radiotherapy, must have been received after CAR T-cell therapy
•9. Absolute neutrophil count (ANC) of ≥ 1.0×109/L without growth factor support for 3 days prior to screening assessment.
+9 more criteria

Exclusion Criteria

•Subjects will be ineligible for this study if they meet the following criteria:
•1. 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)
•2. 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
•3. History of Richter's transformation of chronic lymphocytic leukemia (CLL)
•4. Treatment with CAR T-cell therapy on clinical trial as immediate treatment before enrollment
•5. Prior treatment with lonca
•6. 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
•7. 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.
•8. Subjects with active cardiac atrial or cardiac ventricular lymphoma involvement
•9. History of myocardial infarction, cardiac angioplasty or stenting, unstable angina, or other clinically significant cardiac disease within 12 months of enrolment
+8 more criteria

Locations (1)

MD Anderson Cancer Center

Houston, Texas, United States

Key Dates

Start Date

September 23, 2022

Primary Completion Date

January 30, 2030

Completion Date

January 30, 2030

Last Updated

January 12, 2026

Enrollment

ESTIMATED participants

Conditions

Large B-cell LymphomaLymphoma

Interventions

Loncastuximab Tesirine

DRUG

Contacts

Paolo Strati, MD

CONTACT

(713) 745-1776 pstrati@mdanderson.org

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 12, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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