Actively Recruiting
A Single-Arm, Multicenter, Prospective, Exploratory Clinical Study of Axicabtagene Ciloleucel Injection in Patients With Relapsed/Refractory Follicular Lymphoma
Led by The First Affiliated Hospital of Xiamen University · Updated on 2025-02-13
30
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the use of Axicabtagene Ciloleucel Injection to treat Chinese patients with relapsed or refractory follicular lymphoma (FL). This is a Phase II, single-arm, multicenter study aiming to assess both the effectiveness and safety of this treatment in patients who have not responded to prior therapies, including anti-CD20 monoclonal antibody combined with an alkylating agent. The trial plans to enroll 30 subjects for this purpose. Participants will first undergo leukapheresis to collect mononuclear cells from their blood, targeting a volume of approximately 8-10 liters to obtain 5-10 billion cells. Before receiving the Axicabtagene Ciloleucel Injection, subjects will be given pre-treatment chemotherapy with cyclophosphamide and fludarabine intravenously on days -5, -4, and -3. On day 0, a single dose of CAR-T cells (Axicabtagene Ciloleucel Injection) will be infused intravenously, dosed by body weight with specific minimum and maximum limits. Throughout the study, participants will be closely monitored for treatment response and safety over up to 36 months. Researchers will evaluate outcomes such as the best objective response rate at 6 months, progression-free survival, complete and partial response rates, duration of response, and overall survival. Assessments will include clinical exams, laboratory tests, and imaging to track disease status and any side effects. The study is sponsored by The First Affiliated Hospital of Xiamen University and begins in February 2025.
CONDITIONS
Brief Title
Axicabtagene Ciloleucel Injection in Patients With Relapsed/Refractory Follicular Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed follicular lymphoma (FL) grade 1, 2, or 3a according to WHO 2016 classification criteria
- Relapsed or refractory FL after at least second-line therapy including anti-CD20 monoclonal antibody combined with an alkylating agent
- At least one measurable lesion according to Lugano 2014 classification
- Previous systemic therapy finished at least 2 weeks or 5 half-lives before leukapheresis (except certain immune checkpoint therapies)
- Toxicities from prior therapy stabilized to grade 1 or less
- Age 18 years or older
- ECOG physical status score of 0 or 1
- Absolute neutrophil count (ANC) ≥ 1.0 x 10^9/L
- Platelet count ≥ 75 x 10^9/L
- Absolute lymphocyte count ≥ 0.1 x 10^9/L
- Adequate renal, hepatic, pulmonary, and cardiac function
- Negative serum pregnancy test for women of childbearing potential
You will not qualify if you...
- Converted follicular lymphoma
- Small lymphocytic lymphoma
- Follicular lymphoma grade 3b
- Lymphoplasmacytic lymphoma
- Other malignant tumors unless disease-free and untreated for at least 3 years (except certain skin and in situ carcinomas)
- Autologous hematopoietic stem cell transplant within 6 weeks prior to infusion
- Prior allogeneic hematopoietic stem cell transplant
- Previous CD19-targeted therapy or CAR-T/genetically modified T-cell therapy
- History of severe rapid-onset hypersensitivity to aminoglycosides
- Uncontrolled infections requiring intravenous therapy
- Known HIV or active hepatitis infection
- Lymphoma involving entire gastric wall
- Presence of indwelling tubes or catheters (except central venous access devices)
- Primary central nervous system lymphoma
- Lymphomatous infiltration of heart atria or ventricles
- Significant cardiac disease within 12 months before enrollment
- Urgent treatment needed due to rapid tumor progression
- End-organ damage from autoimmune disease or recent immunosuppressive therapy
- Recent symptomatic deep vein thrombosis or pulmonary embolism
- Severe hypersensitivity to study drugs
- Live attenuated vaccines within 6 weeks before pretreatment
- Breastfeeding women
- Unwillingness to use contraception during and 6 months after study treatment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 1 week
Participants receive pre-treatment chemotherapy followed by a single infusion of Axicabtagene Ciloleucel Injection.
1 baseline visit for leukapheresis and preparation; 1 infusion visit; multiple visits during pre-treatment chemotherapy days -5 to -3
Duration - Up to 36 months
Participants are monitored for safety and efficacy after treatment.
Regular visits for assessments up to 36 months
Trial Site Locations
Total: 1 location
1
Bing Xu
Xiamen, Fujian, China, 361003
Actively Recruiting
Research Team
B
Bing Xu
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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