Study of Axicabtagene Ciloleucel with Radiation for Follicular Lymphoma
This study is looking at the safety of a treatment called axicabtagene ciloleucel (a CAR T-cell therapy) when given with radiation therapy. This treatment uses your own immune cells, called T-cells, which are specially modified to fight cancer. It's for people with follicular lymphoma that has come back or hasn't responded to at least two other treatments. Researchers want to see how safe this combination is, especially looking at side effects like cytokine release syndrome (CRS). They will also measure how many people respond to the treatment and for how long. The study plans to enroll 20 participants.
- Study design
- This is an interventional study, but the phase is not specified. It plans to enroll 20 participants.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for adverse events through study completion, which is an average of 1 year. Response rates will be assessed at approximately 1 month and 6 months after CAR T-cell therapy.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT06043323
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
Recruiting
PHASE2Ages 18+InterventionalTreatmentM.D. Anderson Cancer CenterInvestigator-initiated
~20 participants
Updated 2026-05-06 on ClinicalTrials.gov
What's tested:Axicabtagene CiloleucelCyclophosphamideFludarabine phosphatePrednisoneDiphenhydramineAcetaminophen
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Measured over through study completion; an average of 1 year
Conditions
Where it's being run
1 sites across 1 statesTexas1
Study leadership
- Susan Wu, MD · PRINCIPAL_INVESTIGATOR · M.D. Anderson Cancer Center
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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.
Exclusion
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.
What this trial measures
- Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0through study completion; an average of 1 year