Clinical trial NCT05800067: Axi-cel Retreatment in Relapsed/Refractory LBCL
Official title: A Single-arm Prospective Trial of Axicabtagene Ciloleucel (Axi-cel) Retreatment in Relapsed/Refractory Large B-cell Lymphoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: CAR-T Retreatment
Keywords: Axi-cel retreatment, R/R LBCL
Lead sponsor: Ruijin Hospital
Sponsor class: OTHER
First posted: 2023-04-05
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed description: This study is a prospective, single-arm, open-label two-stage study. There were 6 cases enrolled in Phase 1 and 26 cases enrolled in Phase 2, for a total of 32 cases.

This study aimed to collect data on efficacy and safety after secondary infusion treatment with aquilencel in adult patients with r/r LBCL after the first treatment of CD19 CAR-T. No form of grouping was performed in this study, and subgroup analyses were performed based on the actual data collected.

Research Process:

The patient has been evaluated for disease after the first treatment of akilencel, and the investigator decided to give the patient a second treatment based on clinical practice. Obtain informed consent before the second treatment of CD19 CAR-T, collect data on the patient's disease status before the second dose, previous and current decontamination treatment and other related treatments, and perform imaging tests such as positron emission tomography and computed tomography (PET-CT) or electronic computed tomography (CT) on the same day, day 15, day 29, month 3 after secondary administration, and 6, 9, 12, 18 and 24 months after secondary administration to confirm the collection of efficacy data, and investigators evaluated data on adverse events related to CD19 CAR-T, related laboratory results, etc.

Eligibility criteria: Inclusion Criteria:

1. Informed Consent Form (ICF);
2. Adults with diagnosed relapsed or refractory Large B-cell lymphoma who have completed initial treatment with Axi-cel;
3. non-CR or relapsed after the initial Axi-cel infusion;
4. CD19 status by lymphoma lesion biopsy is at the discretion of investigators.
5. 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.

8）No serious adverse events occurred during the initial Axi-cel treatment or the adverse events in the first treatment period have recovered.

Exclusion Criteria:

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

Primary outcomes:
measure: Best objective response rate
timeFrame: Up to 2 years
Secondary outcomes:
measure: Complete response (CR) rate
timeFrame: Up to 2 years
measure: Duration of Response (DOR)
timeFrame: Up to 2 years
measure: Progression-Free Survival (PFS)
timeFrame: Up to 2 years
measure: Overall Survival (OS)
timeFrame: Up to 2 years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
state: Shanghai
Study officials:
affiliation: Ruijin hospital,China
name: weili Zhao, MD,PhD
role: STUDY_CHAIR
References: