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

NCT05464719 | Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: 2022-0147NCI-2022-05750
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Large B-cell Lymphoma; Lymphoma

Outcome Measures

Primary Outcomes (1)

• Rate of conversion to complete response

  through study completion and or average of 1 year

Study Arms (1)

Loncastuximab Tesirine

EXPERIMENTAL

Participants will receive Loncastuximab Tesirine (lonca) by vein.

Drug: Loncastuximab Tesirine

Interventions

Loncastuximab Tesirine DRUG

Given by IV

Also known as: Lonca

Loncastuximab Tesirine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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
• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

MD Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Related Links

• MD Anderson Cancer Center

MeSH Terms

Conditions

Lymphoma

Interventions

loncastuximab tesirine

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Paolo Strati, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Paolo Strati, MD

CONTACT

(713) 745-1776; pstrati@mdanderson.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2022
• First Posted: July 19, 2022
• Study Start: September 23, 2022
• Primary Completion (Estimated): January 30, 2030
• Study Completion (Estimated): January 30, 2030
• Last Updated: January 12, 2026

Record last verified: 2026-01

Locations

US (1)