A Phase 2 Study of Loncastuximab Tesirine and Rituximab as Bridging Therapy Prior to Standard-of-care CD19 CAR T-cell Therapy in Patients With Large B-cell Lymphoma

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

The purpose of this clinical trial is to learn if the study treatment Loncastuximab tesirine and Rituximab is safe and efficient before standard of care chimeric antigen receptor T-cell (CAR-T) therapy in patients with relapsed or refractory large B-cell lymphoma.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
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• Subject aged ≥ 18 years.

• Intended to receive commercial CD19-directed CAR-T cell therapy (axi-cel and liso-cel).

• Need for bridging therapy as deemed clinically necessary by the treating physician.

• Relapsed or refractory DLBCL, tFL or PMBCL as defined by the 2016 World Health Organization classification (including patients with DLBCL transformed from indolent lymphoma), or high-grade B-cell lymphoma (HGBL), not otherwise specified, and HGBL with MYC and BCL2 and/or BCL6 rearrangements.

⁃ -Relapsed (disease that has recurred following a response) or refractory (disease that failed to respond to prior therapy) disease following at least one multi-agent systemic treatment regimen.

• Measurable disease as defined by the 2014 Lugano Classification as assessed by positron-emission tomography (PET)- computed tomography (CT) or by CT or magnetic resonance imaging (MRI) if the tumor is not fluorodeoxyglucose (FDG)-avid on screening PET-CT.

• ECOG Performance Status ≤ 2.

• Time between prior anticancer therapy and first dose of lonca-R as below

‣ Autologous hematopoietic cell transplantation - At least 30 days

⁃ Allogeneic hematopoietic cell transplantation - At least 60 days

⁃ Cytotoxic chemotherapy - At least 21 days

⁃ Non-cytotoxic chemotherapy (e.g., small molecule inhibitor) - At least 14 days

• Adequate organ function as defined as:

‣ Hematologic:

• Absolute neutrophil count (ANC) ≥ 1000/mm3

∙ Platelet count ≥ 75,000/mm3

∙ Hemoglobin ≥ 8 g/dL

⁃ Hepatic:

• Bilirubin ≤1.5 x upper limit of normal (ULN) or ≤3 x ULN with document liver involvement and/ or Gilbert's disease

∙ Transaminases (AST or ALT) ≤ 3 x ULN or ≤ 5 x ULN with documented liver involvement

⁃ Renal:

• Estimated creatinine clearance ≥ 60 mL/min by Cockcroft-Gault formula.

• For female subjects: Negative pregnancy test or evidence of post-menopausal status. The post-menopausal status will be defined as having been amenorrheic for 12 months without an alternative medical cause. The following age-specific requirements apply:

‣ Women \< 50 years of age:

• Amenorrheic for ≥ 12 months following cessation of exogenous hormonal treatments; and

∙ Luteinizing hormone and follicle-stimulating hormone levels in the post-menopausal range for the institution; or

∙ Underwent surgical sterilization (bilateral oophorectomy or hysterectomy).

⁃ Women ≥ 50 years of age:

• Amenorrheic for 12 months or more following cessation of all exogenous hormonal treatments; or

∙ Had radiation-induced menopause with last menses \>1 year ago; or

∙ Had chemotherapy-induced menopause with last menses \>1 year ago; or

∙ Underwent surgical sterilization (bilateral oophorectomy, bilateral salpingectomy, or hysterectomy).

• Female subjects of childbearing potential and male subjects with a sexual partner of childbearing potential must agree to use a highly effective method of contraception and the lactation requirements as described in Sections 5.41.1 and 5.4.2.

• Subjects or their legal representatives must be able to read, understand, and provide informed consent to participate in the trial.

• Willing and capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in the protocol

Locations
United States
Utah
Huntsman Cancer Institute at University of Utah
RECRUITING
Salt Lake City
Contact Information
Primary
Catherine Cromar
catherine.cromar@hci.utah.edu
801-213-5652
Backup
Narendranath Epperla
naren.epperla@hci.utah.edu
801-585-0255
Time Frame
Start Date: 2025-07-01
Estimated Completion Date: 2030-03
Participants
Target number of participants: 29
Treatments
Experimental: Treatment: All Patients
The study will investigate the effectiveness of Loncastuximab tesirine and Rituximab (Lonca-R) prior to standard of care CAR-T cell therapy.
Related Therapeutic Areas
Sponsors
Leads: University of Utah
Collaborators: ADC Therapeutics S.A.

This content was sourced from clinicaltrials.gov