Recruiting
Phase 2

Axicabtagene Ciloleucel & Radiotherapy

Sponsor:

M.D. Anderson Cancer Center

Code:

NCT06043323

Conditions

Follicular Lymphoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Axicabtagene Ciloleucel

Cyclophosphamide

Fludarabine phosphate

Prednisone

Diphenhydramine

Study Details

Brief summary:

To learn about the safety of a drug called axicabtagene ciloleucel given in combination with radiation therapy to patients with relapsed/refractory FL.

Conditions

Follicular Lymphoma

Study ID

NCT06043323

Start date

Jan 8, 2024

Status verified date

Sep, 2026

Completion date

Sep 1, 2028

Anticipated

Primary completion date

Sep 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

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.

Exclusion Criteria:

  • 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.

Study Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Axicabtagene Ciloleuce

Participants will first have a procedure to collect your white blood cells that will be used to make axicabtagene ciloleucel. Then participatns will receive radiation therapy, followed by conditioning chemotherapy and 1 infusion of axicabtagene ciloleucel.

Interventions

Axicabtagene Ciloleucel

Given by IV (vein)

Cyclophosphamide

Given by IV (vein)

Fludarabine phosphate

Given by IV (vein)

Prednisone

Given by IV (vein)

Diphenhydramine

Given by IV (vein)

Acetaminophen

Given by IV (vein)

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Susan Wu, MD

(281) 630-7607sywu1@mdanderson.org

Locations

MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Susan Wu, MD

281-630-7607sywu1@mdanderson.org

More Information

Sponsor

M.D. Anderson Cancer Center

Last update posted

Sep 4, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by M.D. Anderson Cancer Center on 2026-09-04.