Combining CAR T-cell therapy with radiation for relapsed follicular lymphoma
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
This study is testing if combining a new CAR T-cell therapy with radiation can help people with relapsed follicular lymphoma feel better and have fewer side effects.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | M.D. Anderson Cancer Center Academic / other |
| Drugs / interventions | rituximab, CAR-T, CAR T, chemotherapy, radiation, chimeric antigen receptor |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT06043323 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety of axicabtagene ciloleucel, a CAR T-cell therapy, when used alongside radiotherapy in patients with relapsed or refractory follicular lymphoma. The primary focus is to assess the incidence of severe cytokine release syndrome following treatment. Secondary objectives include measuring response rates, duration of response, and overall survival. The study also explores the relationship between tumor burden and treatment response using PET/CT imaging.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with histologically confirmed follicular lymphoma who have not responded to previous therapies.
Not a fit: Patients with early-stage follicular lymphoma or those who have not undergone multiple lines of systemic therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve treatment outcomes for patients with difficult-to-treat follicular lymphoma.
How similar studies have performed: Previous studies have shown promising results with CAR T-cell therapies in hematological malignancies, suggesting potential for success with this combined approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Houston, Texas
- MD Anderson Cancer Center — Houston, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Susan Wu, MD — M.D. Anderson Cancer Center
- Study coordinator: Susan Wu, MD
- Email: sywu1@mdanderson.org
- Phone: (281) 630-7607
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.