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
| NCT ID | NCT06043323 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | M.D. Anderson Cancer Center |
| Condition | Follicular Lymphoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2024-01-08 |
| Primary Completion | 2026-09-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 20 participants in total. It began in 2024-01-08 with a primary completion date of 2026-09-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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.
Contact & Investigator
Susan Wu, MD
PRINCIPAL INVESTIGATOR
M.D. Anderson Cancer Center
Frequently Asked Questions
Who can join the NCT06043323 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Follicular Lymphoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06043323 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06043323 currently recruiting?
Yes, NCT06043323 is actively recruiting participants. Contact the research team at sywu1@mdanderson.org for enrollment information.
Where is the NCT06043323 trial being conducted?
This trial is being conducted at Houston, United States.
Who is sponsoring the NCT06043323 clinical trial?
NCT06043323 is sponsored by M.D. Anderson Cancer Center. The principal investigator is Susan Wu, MD at M.D. Anderson Cancer Center. The trial plans to enroll 20 participants.