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

Recruiting now · Phase 2

Conditions studied: Large B-cell Lymphoma, Lymphoma

In brief

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.

Key facts

Study ID: NCT05464719
Run by: M.D. Anderson Cancer Center
People needed: 30
Starts: 2022-09-23
Expected to finish: 2030-01-30
Last updated by the study team: 2026-07-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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
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.
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

Where it is running

MD Anderson Cancer Center — Houston, Texas, United States (enrolling)

Full record on ClinicalTrials.gov

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