Large B-cell LymphomaNCT06142175
Relmacabtagene Autoleucel in Patients With LBCL
An observational study of Large B-cell Lymphoma, run by Shanghai Ming Ju Biotechnology Co., Ltd. at 1 site in China.
Trial summary
To evaluate the efficacy and safety of Relmacabtagene autoleucel for the treatment of adult patients with relapsed or refractory (r/r) large B-cell lymphoma (LBCL) in real-world Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Large B-cell Lymphoma
- What is being tested?
- Relmacabtagene Autoleucel
- Type of treatment
- Injection or infusion
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 28 Dec 2022to 31 Dec 2024
- Phase
- Observational
- 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
Study population: r/r LBCL
Who may be able to join
- Adult patients with established r/r LBCL;
- Patients already treated with commercially available Relmacabtagene Autoleucel
Who cannot join
- No
Trial locations and contacts
1 site in 1 country.
Weili Zhao, PhD contact
China1 site, 1 recruiting
- Recruiting
Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine,
Shanghai, Shanghai Municipality, 200025
Weili Zhao, PhD
About this study
Official title: A Real World Study of Treatment of Relmacabtagene Autoleucel in Relapsed or Refractory Large B-Cell Lymphoma
To evaluate the efficacy and safety of Relmacabtagene autoleucel for the treatment of adult patients with relapsed or refractory (r/r) large B-cell lymphoma (LBCL) in real-world
Read the detailed description
This is a post-marketing, multicenter, observational real-world study, including prospective and retrospective studies. The purpose of this study is to collect efficacy and safety data over a 6-month period following treatment of adult patients with r/r LBCL with Relmacabtagene autoleucel. The treating physicians in the study will determine the most appropriate diagnostic and therapeutic regimen for their patients based on clinical practice.There will be no therapeutic intervention as a result of this study. There will be no subgroups of any kind in this study, and subgroup analyses will be performed based on the actual data collected during the analysis.
- Conditions
- Large B-cell Lymphoma
- Being tested
- Relmacabtagene Autoleucel
- Keywords
- Relmacabtagene Autoleucel, Chimeric antigen receptor T cells
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Relmacabtagene AutoleucelBiological
Also called JWCAR029
A single infusion of chimeric antigen receptor (CAR)-transduced autologous T cells
| Study group | Role | What they receive |
|---|---|---|
| Relmacabtagene Autoleucel | Relmacabtagene Autoleucel administered as a single IV infusion at a target dose of 1 x 10^8 anti-cluster of differentiation (CD)19 chimeric antigen receptor (CAR) transduced autologous T cells on Day1. Receives: Biological: Relmacabtagene Autoleucel |
What is being measured
The primary outcome is the main question the study is designed to answer.
ORR
Percentage of participants with CR or PR
Measured: 6 months
Secondary outcomes (5)
CRR
Complete response rate
Measured: 6 months
DOR
Duration of response
Measured: 6 months
Progression-Free Survival (PFS)
PFS is defined as the time from the Relmacabtagene Autoleucel infusion date to the date of disease progression per Lugano classification or death from any cause.
Measured: 6 months
Overall Survival (OS)
OS is defined as the time from Relmacabtagene Autoleucel infusion to the date of death from any cause.
Measured: 6 months
Adverse events (AEs)
Types, frequency, and severity of adverse events and laboratory anomalies Physiological parameter
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2023
- Study start28 Dec 2022
- 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 Large B-cell LymphomaStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Other
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Ming Ju Biotechnology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Weili Zhao, PhD, Principal investigator, Ruijin HospitalHuiqiang Huang, PhD, Principal investigator, Sun Yat-sen UniversityLiang Huang, PhD, Principal investigator, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, ChinaPing Li, Principal investigator, Shanghai Tongji Hospital, Tongji University School of MedicineHeng Mei, Principal investigator, Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyHongmei Jing, Principal investigator, Peking University Third HospitalWenbin Qian, Principal investigator, Second Affiliated Hospital, Zhejiang University, School of MedicineDepei Wu, Principal investigator, The First Affiliated Hospital of Soochow University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06142175
- Sponsor's protocol ID
- JWCAR029-008
- Status last verified
- Nov 2023
- First submitted
- 15 Nov 2023
- Last updated
- 28 Mar 2024
- 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 28 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Real World Study of Treatment of Relmacabtagene Autoleucel in Relapsed or Refractory Large B-Cell Lymphoma
- ClinicalTrials.gov ID
- NCT06142175
- Acronym / sponsor ID
- JWCAR029-008
- Conditions
- Large B-cell Lymphoma
- Keywords
- Relmacabtagene Autoleucel, Chimeric antigen receptor T cells
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Shanghai Ming Ju Biotechnology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 28 Dec 2022 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 21 Nov 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.
To evaluate the efficacy and safety of Relmacabtagene autoleucel for the treatment of adult patients with relapsed or refractory (r/r) large B-cell lymphoma (LBCL) in real-world
Detailed description
This is a post-marketing, multicenter, observational real-world study, including prospective and retrospective studies. The purpose of this study is to collect efficacy and safety data over a 6-month period following treatment of adult patients with r/r LBCL with Relmacabtagene autoleucel. The treating physicians in the study will determine the most appropriate diagnostic and therapeutic regimen for their patients based on clinical practice.There will be no therapeutic intervention as a result of this study. There will be no subgroups of any kind in this study, and subgroup analyses will be performed based on the actual data collected during the analysis.
Study design
- Observational model
- Case only
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Relmacabtagene Autoleucel | – | Biological: Relmacabtagene AutoleucelRelmacabtagene Autoleucel administered as a single IV infusion at a target dose of 1 x 10^8 anti-cluster of differentiation (CD)19 chimeric antigen receptor (CAR) transduced autologous T cells on Day1. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- r/r LBCL
Key inclusion criteria (2 listed)
- Adult patients with established r/r LBCL;
- Patients already treated with commercially available Relmacabtagene Autoleucel
Key exclusion criteria (1 listed)
- No
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 |
|---|---|---|
| Relmacabtagene AutoleucelAlso: JWCAR029A single infusion of chimeric antigen receptor (CAR)-transduced autologous T cells | Biological | Relmacabtagene Autoleucel |
Primary outcome
ORR
Time frame: 6 months
Percentage of participants with CR or PR
5 secondary outcomes
CRR
Time frame: 6 months
DOR
Time frame: 6 months
Progression-Free Survival (PFS)
Time frame: 6 months
Overall Survival (OS)
Time frame: 6 months
Adverse events (AEs)
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2024.
- 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, PhD contact
Weili Zhao, PhD principal investigator
Ruijin Hospital
Huiqiang Huang, PhD principal investigator
Sun Yat-sen University
Liang Huang, PhD principal investigator
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Large B-cell Lymphoma, run by Shanghai Ming Ju Biotechnology Co., Ltd. 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 2 inclusion and 1 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 28 Mar 2024. 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 Medical JWCAR029, PhD (+86 21 50464201, JWCAR029Medical@jwtherapeutics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ORR (time frame: 6 months). 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 28 Mar 2024.