Axi-cel Retreatment in Relapsed/Refractory LBCL

NCT05800067 | Unknown

• 1 other identifier: FKC876-LBCL-001
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective, single-arm, clinical study to explore the efficacy and safety of Axi-cel retreatment in R/R LBCL in Shanghai Ruijin Hospital in China. R/R LBCL patients who treated with Axi-cel got non-CR or relapsed were eligible for Axi-cel retreatment in this study. Patients will receive the standard dose of Axi-cel and follow the standard process. Other related treatment like bridging therapy or combination therapy will be based on patients status and investigators' decision. The primary endpoint is ORR, the secondary endpoint is CR, PR, DOR, PFS, OS and AE. A total of 32 patients is planned to be enrolled in this study. The trial will not go on if nobody got CR or PR in first 6 patients.

Conditions

CAR-T Retreatment

Keywords

Axi-cel retreatment, R/R LBCL

Outcome Measures

Primary Outcomes (1)

• Best objective response rate

  ORR, defined as the incidence of either a complete response or a partial response assessed by investigators according to Lugano 2014 criteria.

  Up to 2 years

Secondary Outcomes (4)

• Complete response (CR) rate

  Up to 2 years

• Duration of Response (DOR)

  Up to 2 years

• Progression-Free Survival (PFS)

  Up to 2 years

• Overall Survival (OS)

  Up to 2 years

Study Arms (1)

Axi-cel

EXPERIMENTAL

Patients will receive a target dose of 2×10⁶ Axi-cel per kilogram of body weight after receiving a conditioning regimen. The conditioning regimen and dosage will be at investigator's discretion based on patient's status.

Drug: axi-cel

Interventions

axi-cel DRUG

Axicabtagene ciloleucel (Axi-cel) is an autologous anti-CD-19 chimeric antigen receptor(CAR) T-cell therapy approved by FDA in 2017 for the treatment of patients with relapsed/refractory large B-cell lymphoma (R/R LBCL). Now, it is the standard treatment for these patients recommended by NCCN and other guidelines. Axi-cel was approved for R/R LBCL patients who had received 2 or more prior lines of therapy on 2021 June in China.

Axi-cel

Eligibility Criteria

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

You may qualify if:

• Informed Consent Form (ICF);
• Adults with diagnosed relapsed or refractory Large B-cell lymphoma who have completed initial treatment with Axi-cel;
• non-CR or relapsed after the initial Axi-cel infusion;
• CD19 status by lymphoma lesion biopsy is at the discretion of investigators.
• Antidrug antibodies (ADA) of Axi-cel should be performed prior to retreatment. 6) Lymphodepleting chemotherapy (fludarabine and cyclophosphamid) related toxicities were ≤ grade 1 or at the base line of Axi-cel initial treatment.
• ）No serious adverse events occurred during the initial Axi-cel treatment or the adverse events in the first treatment period have recovered.

You may not qualify if:

• Patients with hypersensitivity to any active ingredient or excipients (dimethyl sulfoxide, compound electrolyte injection, human albumin);
• Uncontrolled systemic fungal, bacterial, viral, or other infections

Sponsors & Collaborators

• Ruijin Hospital: lead

Study Sites (1)

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200025, China

RECRUITING

Study Officials

• weili Zhao, MD,PhD

  Ruijin hospital,China

  STUDY CHAIR

Central Study Contacts

li Wang, MD

CONTACT

15214370575; 15214370575@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2022
• First Posted: April 5, 2023
• Study Start: March 4, 2023
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: April 5, 2023

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)