Axicabtagene Ciloleucel Injection in Patients With Relapsed/Refractory Follicular Lymphoma

NCT06826118 | Recruiting Phase 2

• 1 other identifier: XMDYYYXYK-16
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

A prospective collection of data on the treatment of Chinese patients with relapsed/refractory follicular lymphoma (FL) using Axicabtagene Ciloleucel Injection, and evaluation of the efficacy and safety of Axicabtagene Ciloleucel Injection in this treatment.

Conditions

Lymphoma; Follicular Lymphoma; Refractory Lymphoma

Outcome Measures

Primary Outcomes (1)

• Best Objective Response Rate (bORR) at 6 months

  This is defined as the proportion of subjects in the modified Intent-To-Treat (mITT) analysis set who achieve a best response of Complete Remission (CR) or Partial Remission (PR) following infusion of Axicabtagene Ciloleucel Injection, as determined by the treating physician, and who have the opportunity to complete the 6-month assessment. Before the data cutoff date, all subjects who do not meet the criteria for objective response will be considered as having no objective response (e.g., those without valid assessments or who did not undergo efficacy evaluation).

  Up to 36 months

Secondary Outcomes (5)

• Progression-Free Survival (PFS)

  Up to 36 months

• Complete Response (CR) Rate

  Up to 36 months

• Partial Response (PR) Rate

  Up to 36 months

• Duration of Response (DOR)

  Up to 36 months

• Overall Survival (OS)

  Up to 36 months

Study Arms (1)

Axicabtagene Ciloleucel Injection

EXPERIMENTAL

The total blood volume circulated is recommended to be approximately 8-10 liters to obtain about (5-10)×10\^9 mononuclear cells. The collected sample will be packaged according to the study product manual and quickly transported to the cell preparation center for the preparation of Axicabtagene Ciloleucel Injection. Pre-treatment chemotherapy. Axicabtagene Ciloleucel Injection infusion.

Drug: Axicabtagene Ciloleucel

Interventions

Axicabtagene Ciloleucel DRUG

Pre-treatment chemotherapy: Cyclophosphamide 500 mg/m² and Fludarabine 30 mg/m² will be administered intravenously on Days -5, -4, and -3 (with the day of Axicabtagene Ciloleucel Injection infusion being Day 0). Axicabtagene Ciloleucel Injection infusion: A single dose of autologous T cells transduced with chimeric antigen receptor (CAR) in the form of Axicabtagene Ciloleucel Injection will be administered to the subject intravenously. The target dose is 2.0×10\^6 anti-CD19 CAR-T cells/kg body weight. The minimum dose that can be used is 1.5×10\^6 anti-CD19 CAR-T cells/kg body weight. For subjects with a body weight of ≥100 kg, the maximum total dose is 2.0×10\^8 anti-CD19 CAR-T cells

Also known as: Axicabtagene Ciloleucel Injection

Axicabtagene Ciloleucel Injection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed follicular lymphoma (FL) grade 1, 2, or 3a according to WHO 2016 classification criteria
• Subjects with relapsed or refractory FL after prior second-line or higher therapy Prior therapy must include: anti-CD20 monoclonal antibody in combination with an alkylating agent (anti-CD20 monoclonal antibody monotherapy is not eligible as a line of therapy for eligibility). Subjects who have had stable disease (no recurrence) for more than 1 year after completion of their last treatment do not meet the enrollment criteria Translated with DeepL.com (free version)
• At least one measurable lesion according to the Lugano 2014 classification (Cheson 2014). Lesions with prior radiotherapy were considered measurable only if definitive progression was confirmed after completion of radiotherapy.
• Patients with FL lymphoma secondary to central may be included in the
• Previous systemic therapy at least 2 weeks or 5 half-lives (whichever is shorter) from the start of leukapheresis, except for immune checkpoint inhibitors/agonists; Systemic immune checkpoint inhibitor/agonist therapy at least 3 half-lives from leukapheresis (e.g., Ipilimumab, Ivolumab, Pembrolizumab, Atezolizumab, OX40 agonist, 4-IBB agonist). Atezolizumab, OX40 agonist, 4-IBB agonist)
• Toxic reactions from prior anti-lymphoma therapy must stabilize and recover to ≤ grade 1 (except for non-clinically significant toxicities such as alopecia/balding)
• ≥ 18 years old
• ECOG physical status score of 0 or 1
• Absolute neutrophil count (ANC) ≥ 1.0×10\^9/L
• Platelet count ≥ 75×10\^9/L
• Absolute lymphocyte count ≥ 0.1×10\^ 9/L
• Adequate renal, hepatic, pulmonary, and cardiac function, defined as: 1) total bilirubin (TBIL) ≤ 1.5 times the upper limit of normal (ULN), except in subjects with Gilbert's syndrome; 2) alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 x ULN 3) serum creatinine (Cr) ≤ 1.5 x ULN or creatinine clearance (CCr) ≥ 60 mL/min, with creatinine clearance estimated based on the cockcroft-Gault formula; 4) cardiac ejection fraction ≥ 50%, absence of pericardial effusion as determined by echocardiography (ECHO), and absence of clinically significant cardiac arrhythmia; 5) baseline transcutaneous oxygen saturation \> 92% under room ventilation; 6) absence of clinically significant chest pain; and ) absence of clinically significant pleural effusion.
• A negative serum pregnancy test is required for women of childbearing potential (women who have been surgically sterilized or who are at least 2 years postmenopausal are not considered to be of childbearing potential).

You may not qualify if:

• Converted FL
• Small lymphocytic lymphoma
• The histologic grading of FL was 3b
• lymphoplasmacytic lymphoma
• Subject has had other malignant tumors unless he/she has survived disease-free and has not received antitumor therapy for at least 3 years; except for non-melanoma skin tumors, carcinoma in situ (e.g., cervix, bladder, breast)
• Autologous Hematopoietic Stem Cell Transplantation Within 6 Weeks Prior to Scheduled Infusion of Achille's Bromide Injection
• Has performed allogeneic hematopoietic stem cell transplants
• Previous CD19-targeted therapy
• Previous chimeric antigen receptor cell therapy or other genetically modified T-cell therapy.
• History of severe rapid-onset hypersensitivity reactions to aminoglycosides
• Presence or suspicion of uncontrolled fungal, bacterial, viral or other infections that require intravenous drug therapy
• Known human immunodeficiency virus (HIV) infection or active acute or chronic hepatitis infection (HBV or HCV). Subjects with a history of hepatitis must undergo standard serologic or genetic testing in accordance with the most recent version of clinical guidelines/institutional protocols to confirm resolution of infection prior to enrollment.
• Known history of lymphoma involving the entire gastric wall
• Presence of any indwelling tube or catheter (e.g., percutaneous nephrostomy tube, indwelling urinary catheter, indwelling biliary drain, or pleural/peritoneal/pericardial catheter). Dedicated central venous access catheters such as Port-a-Cath or Hickman catheters are permitted.
• Patients with primary central nervous system lymphoma (PCNSL)

Sponsors & Collaborators

• The First Affiliated Hospital of Xiamen University: lead

Study Sites (1)

Bing Xu

Xiamen, Fujian, 361003, China

RECRUITING

MeSH Terms

Conditions

Lymphoma; Lymphoma, Follicular

Interventions

axicabtagene ciloleucel

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Lymphoma, Non-Hodgkin

Study Officials

• Bing Xu

  The First Aiffiliated hosptical of xiamen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bing Xu

CONTACT

18750918842; xubingzhangjian@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Axicabtagene Ciloleucel Injection

Study Record Dates

• First Submitted: February 10, 2025
• First Posted: February 13, 2025
• Study Start: February 8, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 13, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)