Follicular LymphomaPhase 2NCT06043323
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
A Phase 2 study testing Axicabtagene Ciloleucel, Cyclophosphamide and Fludarabine phosphate in people with Follicular Lymphoma, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
To learn about the safety of a drug called axicabtagene ciloleucel given in combination with radiation therapy to patients with relapsed/refractory FL. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Follicular Lymphoma
- What is being tested?
- Axicabtagene Ciloleucel, Cyclophosphamide and Fludarabine phosphate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Jan 2024to 1 Sep 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
MD Anderson Cancer Center
Houston, Texas, 77030
Susan Wu, MD, 281-630-7607, sywu1@mdanderson.org
About this study
To learn about the safety of a drug called axicabtagene ciloleucel given in combination with radiation therapy to patients with relapsed/refractory FL.
Read the detailed description
Primary Objectives:
The primary objective of this study is to determine the safety of standard of care axicabtagene ciloleucel with bridging radiotherapy (RT) in patients with relapsed or refractory follicular lymphoma, as assessed by the incidence of grade 3 or higher cytokine release syndrome (CRS) within 30 days after chimeric antigen receptor (CAR) T-cell infusion.
Secondary Objectives:
- Establish the rates of CRS and ICANS in patients treated with CAR T-cell therapy and radiation
- Determine complete response rate (CR) at approximately 1 month post CAR T-cell ---therapy
- Determine complete response rate (CR) at approximately 6 month post CAR T-cell ---therapy
- Determine the overall response rate (ORR)
- Determine the duration of response (DOR)
- Determine progression free survival (PFS)
- Determine overall survival (OS)
Exploratory Objectives:
- Assess the impact of tumor burden as measured by metabolic tumor volume and total lesion glycolysis on PET/CT on response following CAR T-cell infusion
- Assess T-cell fitness from blood samples by flow cytometry and ssRNAseq prior to and after bridging RT
- Perform immune profiling of blood samples for T-cell subsets prior to and after bridging RT
- Assess cytokine profile after infusion
- Conditions
- Follicular Lymphoma
- Being tested
- Axicabtagene Ciloleucel, Cyclophosphamide, Fludarabine phosphate, Prednisone, Diphenhydramine
- Medical subject headings
- Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Axicabtagene CiloleucelDrug
Given by IV (vein)
CyclophosphamideDrug
Also called Cytoxan®, Neosar®
Given by IV (vein)
Given by IV (vein)
PrednisoneDrug
Given by IV (vein)
DiphenhydramineDrug
Also called Benadryl®
Given by IV (vein)
AcetaminophenDrug
Also called Tylenol®, Dorcol®, Feverall, Panadol
Given by IV (vein)
| Study group | Role | What they receive |
|---|---|---|
| Axicabtagene Ciloleuce | Experimental | 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. Receives: Drug: Axicabtagene Ciloleucel; Drug: Cyclophosphamide; Drug: Fludarabine phosphate; Drug: Prednisone; Drug: Diphenhydramine; Drug: Acetaminophen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Measured: through study completion; an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start8 Jan 2024
- Primary completion1 Sep 2028 (estimated)
- Study completion1 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Follicular LymphomaStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Susan Wu, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06043323
- Sponsor's protocol ID
- 2023-0087
- Other IDs
- NCI-2023-07173
- Status last verified
- Sep 2026
- First submitted
- 12 Sep 2023
- Last updated
- 4 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06043323
- Acronym / sponsor ID
- 2023-0087
- Conditions
- Follicular Lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 8 Jan 2024 (actual)
- Primary completion
- 1 Sep 2028 (estimated)
- Study completion
- 1 Sep 2028 (estimated)
- First posted
- 21 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To learn about the safety of a drug called axicabtagene ciloleucel given in combination with radiation therapy to patients with relapsed/refractory FL.
Detailed description
Primary Objectives:
The primary objective of this study is to determine the safety of standard of care axicabtagene ciloleucel with bridging radiotherapy (RT) in patients with relapsed or refractory follicular lymphoma, as assessed by the incidence of grade 3 or higher cytokine release syndrome (CRS) within 30 days after chimeric antigen receptor (CAR) T-cell infusion.
Secondary Objectives:
- Establish the rates of CRS and ICANS in patients treated with CAR T-cell therapy and radiation
- Determine complete response rate (CR) at approximately 1 month post CAR T-cell ---therapy
- Determine complete response rate (CR) at approximately 6 month post CAR T-cell ---therapy
- Determine the overall response rate (ORR)
- Determine the duration of response (DOR)
- Determine progression free survival (PFS)
- Determine overall survival (OS)
Exploratory Objectives:
- Assess the impact of tumor burden as measured by metabolic tumor volume and total lesion glycolysis on PET/CT on response following CAR T-cell infusion
- Assess T-cell fitness from blood samples by flow cytometry and ssRNAseq prior to and after bridging RT
- Perform immune profiling of blood samples for T-cell subsets prior to and after bridging RT
- Assess cytokine profile after infusion
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Axicabtagene Ciloleuce | Experimental | Drug: Axicabtagene Ciloleucel, Drug: Cyclophosphamide, Drug: Fludarabine phosphate, Drug: Prednisone, Drug: Diphenhydramine, Drug: AcetaminophenParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Axicabtagene CiloleucelGiven by IV (vein) | Drug | Axicabtagene Ciloleuce |
| CyclophosphamideAlso: Cytoxan®, Neosar®Given by IV (vein) | Drug | Axicabtagene Ciloleuce |
| Fludarabine phosphateGiven by IV (vein) | Drug | Axicabtagene Ciloleuce |
| PrednisoneGiven by IV (vein) | Drug | Axicabtagene Ciloleuce |
| DiphenhydramineAlso: Benadryl®Given by IV (vein) | Drug | Axicabtagene Ciloleuce |
| AcetaminophenAlso: Tylenol®, Dorcol®, Feverall, PanadolGiven by IV (vein) | Drug | Axicabtagene Ciloleuce |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2026.
- M D Anderson Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Susan Wu, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Axicabtagene Ciloleucel, Cyclophosphamide and Fludarabine phosphate in people with Follicular Lymphoma, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Susan Wu, MD ((281) 630-7607, sywu1@mdanderson.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2026; AzTrials last refreshed its copy on 7 Nov 2026.