Clinical trial

Feasibility of Low Dose Radiation as Bridging Therapy for Lisocabtagene Maraleucel in Relapsed B-Cell Non-Hodgkin Lymphoma

Name

0770-22-FB

Description

The goal of this clinical trial is to learn about treatment for people with B-cell lymphoma that did not respond to treatment or that has gotten worse after treatment. The aim of this trial is to answer the following questions: * If it is realistic to give people radiation treatment before they receive a chimeric antigen receptor (CAR) T-cell treatment for their cancer * If it is safe to give people radiation treatment before they receive a CAR T-cell treatment for their cancer

Trial arms

Trial start

2023-03-21

Estimated PCD

2025-07-01

Trial end

2025-07-01

Status

Recruiting

Phase

Early phase I

Treatment

Bridging radiation therapy

Days -20 to -7: Patients will receive 2 fractions of 2 gray (Gy) for a total of 4 Gy received.

Arms:

Single arm

Liso-cel

Day 0: Patients will receive an infusion of liso-cel CAR T-cell product. Prior to the liso-cell infusion (Days -5 to -3), patients will receive lymphodepleting chemotherapy using fludarabine 30mg/m2 and cyclophosphamide 300mg/m2 per institutional standard procedures.

Arms:

Single arm

Other names:

Chimeric antigen receptor (CAR) T-cell product

Post-infusion radiation

Days 30 to 80: Patients eligible for post-infusion radiation will receive a total dose of up to 32 Gy.

Arms:

Single arm

Size

Primary endpoint

Feasibility of the intervention in the proposed study population

Up to 90 days

Eligibility criteria

Inclusion Criteria: 1. Biopsy-proven relapsed or progressive diffuse large B-cell lymphoma (DLBCL), high-grade B-cell lymphoma, primary mediastinal B-cell lymphoma, grade 3B follicular lymphoma, or DLBCL arising from indolent lymphoma meeting an FDA-approved (Food and Drug Administration-approved) indication for liso-cel infusion 2. Presence of disease on imaging including at least one disease site safe for radiation as determined by treating radiation oncologist 3. Willingness to participate in clinical trial and provide informed consent 4. Adequate organ function as assessed by standard institution protocols and United States (US) prescribing information label for comorbidities, heart, and lung function to undergo FDA-approved CAR T-cell therapy as determined by institution 5. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 6. Age 19 years or older, there is no upper limit to the age Exclusion Criteria: 1. Subject is unsafe for radiation therapy as determined by investigator and/or radiation oncologist 2. Diagnosis is primary central nervous system (CNS) lymphoma (secondary CNS lymphoma with additional systemic site is allowed) 3. Requirement for concurrent high dose methotrexate 4. Secondary active malignancy that has not been in remission for at least 2 years. This excludes non-melanoma skin cancer, definitively treated stage 1 solid tumor with low risk or recurrence, and curatively treated localized prostate cancer. 5. Pregnant or nursing women 6. Uncontrolled medical, psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol, as determined by investigator 7. Unwillingness to follow procedures required in the protocol 8. Inadequate organ or hematologic conditions that prohibit the use of lymphodepleting chemotherapy 9. Use of lymphoma-directed therapy within 14 days of T-cell pheresis

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 33, 'type': 'ESTIMATED'}}

Updated at

2023-10-02

1 organization

1 product

7 indications

Organization

University of Nebraska

Product

Liso-cel

Indication

Diffuse Large B Cell Lymphoma

Indication