A Phase II Study of Axicabtagene Ciloleucel, an Anti-CD19 Chimeric Antigen Receptor (CAR) Tcell Therapy, in Combination With Radiotherapy (RT) in Relapsed/Refractory Follicular Lymphoma

The film gives the main points. The full list below is copied from the registry; the study team makes the final decision.

• Age18 Years to no maximum
• SexAll
• Healthy volunteersNo

You may be able to join if

• Eligible subjects will be considered for inclusion if they meet all of the following criteria:
• Men and women 18 years of age or older
• Histologically proven FL (Grade 1-3A) on most recent biopsy, history of transformed follicular lymphoma permitted at clinician discretion)
• Patients with follicular lymphoma must have disease that has relapsed or is refractory to 2 or more prior lines of systemic therapy
• (ECOG) performance status of 0-2
• Medically appropriate for CAR-T cell therapy: adequate organ function CrCL >/= 45 mL/min/m2, hemoglobin level ≥ 8 g/dl, serum alanine aminotransferase (ALT)/aspartate aminotransferase (AST) levels ≤ 2.5 × upper limit of normal (ULN) or ≤ 5 x ULN if documented liver involvement, baseline oxygen saturation levels (SpO2) ≥92% on room air
• Have at least 1 measurable lesion on imaging, defined as a lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) and ≥1 cm on CT, MRI, or clinical exam.
• Prior radiation therapy is permitted provided normal tissue tolerance is not exceeded
• Female of child-bearing potential (FOCBP, defined below) must have a negative pregnancy test within 1 week of simulation for RT
• Ability to understand and the willingness to sign a written informed consent document.

You cannot join if

• History of other (non B-cell lymphoma) invasive malignancy requiring active therapy (systemic therapy, radiation, or surgery) within the past 3 years, excluding non-melanomatous skin cancer
• Women of childbearing potential who are pregnant
• Women who are breastfeeding and unwilling to discontinue prior to lymphodepleting chemotherapy and for 12 months following lymphodepleting chemotherapy and CAR-T cell infusion
• Urgent need for bridging chemotherapy or rituximab between apheresis and CAR T cell product infusion (steroids permitted)
• Additional RT would exceed standard organ at risk constraints
• History of severe, immediate hypersensitivity reaction attributed to aminoglycosides
• Uncontrolled fungal, bacterial, or viral infection requiring intravenous antimicrobials for management. Urinary tract infection and uncomplicated bacterial pharyngitis is permitted if responding to active treatment. Recent COVID19 infection is permitted if patient is deemed medically stable for CAR-T cell therapy.

This is how the treatment is meant to work. Whether it helps, and how safe it is, is what this trial is testing.

axicabtagene ciloleucel. A preparation of autologous peripheral blood T lymphocytes (PBTL) that have been transduced with a gammaretoviral vector expressing a chimeric antigen receptor (CAR) consisting of an anti-CD19 single chain variable fragment (scFv) coupled to the costimulatory signaling domain CD28 and the zeta chain of the T-cell receptor (TCR)/CD3 complex (CD3 zeta), with potential immunostimulating and antineoplastic activities. Upon intravenous infusion and re-introduction of axicabtagene ciloleucel into the patient, these cells bind to and induce selective toxicity in CD19-expressing tumor cells. CD19 antigen is a B-cell specific cell surface antigen that is expressed in all B-cell lineage malignancies. CD3 zeta is one of several membrane-bound polypeptides found in the TCR/CD3 complex; it regulates both the assembly and cell surface expression of TCR complexes. CD28 is essential for CD4+ T-cell proliferation, interleukin-2 production, and T-helper type-2 (Th2) development. NCI Drug Dictionary

Treatments listed in the registry

• Axicabtagene Ciloleucel (Drug): Given by IV (vein)
• Cyclophosphamide (Drug): Given by IV (vein)
• Fludarabine phosphate (Drug): Given by IV (vein)
• Prednisone (Drug): Given by IV (vein)
• Diphenhydramine (Drug): Given by IV (vein)
• Acetaminophen (Drug): Given by IV (vein)

Na · Single Group · masking: None

As the registry describes them. Requirements to join, such as a tissue sample, are in the eligibility list above even when on-study procedures are optional. Ask the study team which steps apply to you.

• blood samples: Part of the study plan
• CT scans: Part of the study plan
• PET scans: Part of the study plan
• radiation: Part of the study plan

Main goals

• Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0 (through study completion; an average of 1 year)

Planned enrollment: 20 (estimated).

• MD Anderson Cancer Center, Houston, Texas

Site status as of Oct 30, 2026. Check the live record before contacting a site.

• ClinicalTrials.gov NCT06043323
• NCI Drug Dictionary: C120309

Registry record reviewed as fetched Oct 30, 2026, last updated by the sponsor Sep 3, 2026. Public record; not medical advice.