Lymphoma, B-CellNCT06142188
Relmacabtagene Autoleucel in Hematologic Malignancies
An observational study of Lymphoma, B-Cell and Large B-cell Lymphoma, run by Shanghai Ming Ju Biotechnology Co., Ltd. at 2 sites in China.
Trial summary
To evaluate the efficacy and safety of Relmacabtagene Autoleucel in the treatment of adult patients with hematologic malignancies in real-world Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoma, B-Cell, Large B-cell Lymphoma, Follicular Lymphoma
- What is being tested?
- Relmacabtagene Autoleucel
- Type of treatment
- Injection or infusion
- How many people
- 150 participants
- Where
- 2 sitesChina
- Study dates
- 28 Dec 2023to 31 Dec 2038
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Hematologic Malignancies
Who may be able to join
- Signed informed consent
- Patients who have been treated with Relma-cel, including those who have received off-label products;
- If previously enrolled in another clinical study, they must have completed follow-up in the previous study, or have withdrawn or lost follow-up in the previous study.
Who cannot join
- 1.Patients who have been treated with Relma-cel and then have been treated with other CAR-T products.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100010
Yuqing Song, PhD
Peking University International Hospital
Beijing, Beijing Municipality, 100010
Xinjian Liu
About this study
Official title: A Real-world Study for the Treatment of Hematologic Malignancies With Relmacabtagene Autoleucel
To evaluate the efficacy and safety of Relmacabtagene Autoleucel in the treatment of adult patients with hematologic malignancies in real-world
Read the detailed description
The purpose of this study is to observationally evaluate the efficacy and safety data of Relmacabtagene Autoleucel for the treatment of patients with hematologic malignancies for up to 15 years after infusion. The treating physician will determine the most appropriate diagnostic and therapeutic regimen for the patient based on clinical practice. No therapeutic intervention will be administered to patients in this study.
- Conditions
- Lymphoma, B-Cell, Large B-cell Lymphoma, Follicular Lymphoma
- Being tested
- Relmacabtagene Autoleucel
- Keywords
- Relmacabtagene Autoleucel, Chimeric antigen receptor T cells
- Medical subject headings
- Lymphoma, B-Cell, Lymphoma, Follicular
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 [CMR;CRR] or PR [partial metabolic response (PMR);
Measured: 15 years
Secondary outcomes (5)
CRR
Complete response rate
Measured: 15 years
Duration of response (DOR)
Time from first response(PR or CR) to disease progression or death from any cause.
Measured: 15 years
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: 15 years
Overall Survival (OS)
OS is defined as the time from Relmacabtagene Autoleucel infusion to the date of death from any cause.
Measured: 15 years
Adverse events (AEs)
Types, frequency, and severity of adverse events and laboratory anomalies Physiological parameter
Measured: 15 years
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 2023 (estimated)
- Primary completion31 Dec 2038 (estimated)
- Study completion31 Dec 2038 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lymphoma, B-CellStudies 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
- Retrospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Ming Ju Biotechnology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06142188
- Sponsor's protocol ID
- JWCAR029418
- Status last verified
- Nov 2023
- First submitted
- 15 Nov 2023
- Last updated
- 21 Nov 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 21 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Real-world Study for the Treatment of Hematologic Malignancies With Relmacabtagene Autoleucel
- ClinicalTrials.gov ID
- NCT06142188
- Acronym / sponsor ID
- JWCAR029418
- Conditions
- Lymphoma, B-Cell, Large B-cell Lymphoma, Follicular Lymphoma
- Keywords
- Relmacabtagene Autoleucel, Chimeric antigen receptor T cells
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Shanghai Ming Ju Biotechnology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 28 Dec 2023 (estimated)
- Primary completion
- 31 Dec 2038 (estimated)
- Study completion
- 31 Dec 2038 (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 in the treatment of adult patients with hematologic malignancies in real-world
Detailed description
The purpose of this study is to observationally evaluate the efficacy and safety data of Relmacabtagene Autoleucel for the treatment of patients with hematologic malignancies for up to 15 years after infusion. The treating physician will determine the most appropriate diagnostic and therapeutic regimen for the patient based on clinical practice. No therapeutic intervention will be administered to patients in this study.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- 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
- Hematologic Malignancies
Key inclusion criteria (3 listed)
- Signed informed consent
- Patients who have been treated with Relma-cel, including those who have received off-label products;
- If previously enrolled in another clinical study, they must have completed follow-up in the previous study, or have withdrawn or lost follow-up in the previous study.
Key exclusion criteria (1 listed)
- 1.Patients who have been treated with Relma-cel and then have been treated with other CAR-T products.
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: 15 years
Percentage of participants with CR [CMR;CRR] or PR [partial metabolic response (PMR);
5 secondary outcomes
CRR
Time frame: 15 years
Duration of response (DOR)
Time frame: 15 years
Progression-Free Survival (PFS)
Time frame: 15 years
Overall Survival (OS)
Time frame: 15 years
Adverse events (AEs)
Time frame: 15 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lymphoma, B-Cell and Large B-cell Lymphoma, run by Shanghai Ming Ju Biotechnology Co., Ltd. at 2 sites 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 3 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: opening soon, as of the sponsor's last update on 21 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yuqing Song, PhD (+86 010-88121122, songyuqin622@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ORR (time frame: 15 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 21 Nov 2023.