CAR-T RetreatmentNCT05800067
Axi-cel Retreatment in Relapsed/Refractory LBCL
A study testing axi-cel in people with CAR-T Retreatment, run by Ruijin Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- CAR-T Retreatment
- What is being tested?
- axi-cel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteChina
- Study dates
- 4 Mar 2023to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- 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.
- 8）No serious adverse events occurred during the initial Axi-cel treatment or the adverse events in the first treatment period have recovered.
Who cannot join
- Patients with hypersensitivity to any active ingredient or excipients (dimethyl sulfoxide, compound electrolyte injection, human albumin);
- Uncontrolled systemic fungal, bacterial, viral, or other infections
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200025
Weili Zhao, M.D. and Ph.D, zhao.weili@yahoo.com
About this study
Official title: A Single-arm Prospective Trial of Axicabtagene Ciloleucel (Axi-cel) Retreatment in Relapsed/Refractory Large B-cell Lymphoma
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.
Read the 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.
- Conditions
- CAR-T Retreatment
- Being tested
- axi-cel
- Keywords
- Axi-cel retreatment, R/R LBCL
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
axi-celDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: axi-cel |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 2 years
Secondary outcomes (4)
Complete response (CR) rate
Complete response assessed by investigators according to Lugano 2014 criteria.
Measured: Up to 2 years
Duration of Response (DOR)
Among subjects who experience an objective response, DOR is defined as the date of their first objective response (which is subsequently confirmed) to disease progression per the revised IWG Response Criteria for Malignant Lymphoma or death regardless of cause. Subjects not meeting the criteria for progression or death by the analysis data cutoff date will be censored at their last evaluable disease assessment date and their response will be noted as ongoing.
Measured: Up to 2 years
Progression-Free Survival (PFS)
PFS is defined as the time from the axicabtagene ciloleucel infusion date to the date of disease progression per the revised IWG Response Criteria for Malignant Lymphoma or death from any cause. Subjects not meeting the criteria for progression by the analysis data cutoff date will be censored at their last evaluable disease assessment date.
Measured: Up to 2 years
Overall Survival (OS)
OS is defined as the time from axicabtagene ciloleucel infusion to the date of death. Subjects who have not died by the analysis data cutoff date will be censored at their last contact date.
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2023
- Study start4 Mar 2023
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CAR-T RetreatmentStudies of the same condition, open and under way.
- More trials run by Ruijin HospitalThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- weili Zhao, MD,PhD, Study chair, Ruijin hospital,China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05800067
- Sponsor's protocol ID
- FKC876-LBCL-001
- Status last verified
- Aug 2022
- First submitted
- 2 Dec 2022
- Last updated
- 5 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-arm Prospective Trial of Axicabtagene Ciloleucel (Axi-cel) Retreatment in Relapsed/Refractory Large B-cell Lymphoma
- ClinicalTrials.gov ID
- NCT05800067
- Acronym / sponsor ID
- FKC876-LBCL-001
- Conditions
- CAR-T Retreatment
- Keywords
- Axi-cel retreatment, R/R LBCL
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- 4 Mar 2023 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 5 Apr 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Axi-cel | Experimental | Drug: axi-celPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (2 listed)
- Patients with hypersensitivity to any active ingredient or excipients (dimethyl sulfoxide, compound electrolyte injection, human albumin);
- Uncontrolled systemic fungal, bacterial, viral, or other infections
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 |
|---|---|---|
| axi-celAxicabtagene 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. | Drug | Axi-cel |
Primary outcome
Best objective response rate
Time frame: Up to 2 years
ORR, defined as the incidence of either a complete response or a partial response assessed by investigators according to Lugano 2014 criteria.
4 secondary outcomes
Complete response (CR) rate
Time frame: Up to 2 years
Duration of Response (DOR)
Time frame: Up to 2 years
Progression-Free Survival (PFS)
Time frame: Up to 2 years
Overall Survival (OS)
Time frame: Up to 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2023.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
weili Zhao, MD,PhD study chair
Ruijin hospital,China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing axi-cel in people with CAR-T Retreatment, run by Ruijin Hospital at 1 site in China.
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 6 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 5 Apr 2023. 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 China. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact li Wang, MD (15214370575 ext. +86, 15214370575@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Best objective response rate (time frame: Up to 2 years). 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 5 Apr 2023.