Non-Hodgkin LymphomaPhase 2NCT06479356
CD19-targeted CAR T Cells for Relapsed or Refractory (R/R) Large B-cell Lymphoma
A Phase 2 study testing Relma-cel in people with Non-Hodgkin Lymphoma and Large B-cell Lymphoma, run by Shanghai Ming Ju Biotechnology Co., Ltd. at 1 site in China.
Trial summary
This is an open-label, single-arm study to treat the adult R/R Large B-cell Lymphoma subjects with Relmacabtagene autoleucel (relma-cel) in China. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Hodgkin Lymphoma, Large B-cell Lymphoma
- What is being tested?
- Relma-cel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteChina
- Study dates
- 15 Aug 2024to 31 Dec 2026
- Phase
- Phase 2
- 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
Who may be able to join
- ≥18 years old;
- Sign on the informed consent;
- Subjects must have histologically confirmed Large B-cell Lymphoma;
- Subjects had been treated with anthracyclines and rituximab(or other CD20-targeted antibodies) and had relapsed, failed to respond, or progressed after at least two lines of therapy including autologous hematopoietic stem cell transplantation(auto-HSCT);
- Subjects have accessible PET-positive lesion and have measurable CT-positive lesion according to Lugano Classification;
- Eastern Cooperative Oncology Group(ECOG) performance status of 0 or 1;
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- Adequate organ function;
- Adequate vascular access for leukapheresis procedure;
- Subjects who have previously received CD19 targeted therapy must confirm that lymphoma lesions still express CD19;
- Women of childbearing potential must agree to use highly effective methods of contraception for 1 year after the last dose of Relma-cel;
- Males who have partners of childbearing potential must agree to use an effective barrier contraceptive method for 1 year after the last dose of Relma-cel.
Who cannot join
- Primary CNS lymphoma;
- History of another primary malignancy that has not been in remission for at least 2 years;
- Subjects has HBV,HCV,HIV or syphilis infection at the time of screening;
- Active deep venous thrombosis(DVT)/Pulmonary embolism(PE),or active DVT/PE requires anti-coagulation within 3 months prior to signing the ICF;
- Subjects with uncontrolled systemic fungal,bacterial,viral or other infection;
- Presence of acute or chronic graft-versus-host disease(GVHD);
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- History of any serious cardiovascular disease or presence of clinically relevant CNS pathology;
- Pregnant or nursing woman;
- Subjects using of any chemotherapy,corticosteroid,experiment agents,GVHD therapies,radiation,allo-HSCT or any other therapies for lymphoma must go through a specific wash-out period before leukapheresis;
- Uncontrolled conditions or unwillingness or inability to follow the procedures required in the protocol;
- Received CAR T-cell or other genetically-modified T-cell therapy previously.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Tianjin Cancer Hospital
Tianjin, Tianjin Municipality
Huilai Zhang, zhlwgq@126.com
About this study
Official title: An Open-Label, Single-Arm Study of Relma-cel, CD19-targeted Chimeric Antigen Receptor (CAR)T Cells for Relapsed or Refractory (R/R) LBCL
This is an open-label, single-arm study to treat the adult R/R Large B-cell Lymphoma subjects with Relmacabtagene autoleucel (relma-cel) in China.
Read the detailed description
This is an open-label, single-arm study conducted in adult subjects with R/R LBCL in China to evaluate efficacy，safety and pharmacokinetics(PK) of relma-cel.
Relma-cel was approved by the China National Medical Products Administration(NMPA)in September 2021(Acceptance No:CXSS2000036)for the treatment of adult patients with R/R LBCL after second-line or more systemic therapy.The recommended dose is 1×10^8 CAR+T cells.The indication for this application is R/R LBCL and the recommended dose is 1×10^8 CAR+T cells.
- Conditions
- Non-Hodgkin Lymphoma, Large B-cell Lymphoma
- Being tested
- Relma-cel
- Keywords
- JWCAR029, B-Cell Malignancies, CAR T cells, Chimeric antigen receptor, Relapsed/Refractory
- Medical subject headings
- Lymphoma, Non-Hodgkin, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Relma-celBiological
Also called CD19-targeted Chimeric Antigen Receptor(CAR) T Cells
Relma-cel will be administered at one dose level:1×10^8 CAR+T cells
| Study group | Role | What they receive |
|---|---|---|
| Relma-cel | Experimental | Efficacy, safety and PK of Relma-cel will be evaluated in 1 x 10^8 CAR+T cells dose level Receives: Biological: Relma-cel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate (ORR) in LBCL subjects
Objective response rate (ORR) in 3 month evaluated by investigator of LBCL subjects
Measured: 3 months
Secondary outcomes (10)
Objective response rate (ORR)
Objective response rate (ORR) in 3 month evaluated by IRC of LBCL subjects
Measured: 3 months
Best objective response rate ( Best ORR) in LBCL subjects
Best objective response rate (ORR) evaluated by the investigator and IRC of LBCL subjects
Measured: up to 1 year after Relma-cel infusion
Complete response rate (CRR) in LBCL subjects
Complete response rate (CRR) at any time points evaluated by the investigator
Measured: up to 1 year after Relma-cel infusion
Progression-free survival (PFS)
Progression-free survival
Measured: up to 1 year after Relma-cel infusion
Overall survival (OS)
Overall survival
Measured: up to 1 year after Relma-cel infusion
Duration of response (DOR)
Time from first response (PR or CR) to disease progression or death from any cause
Measured: up to 1 year after Relma-cel infusion
Pharmacokinetic(PK)-Cmax of Relma-cel
Maximum observed concentration of Relma-cel in peripheral blood
Measured: up to 1 year after Relma-cel infusion
Pharmacokinetic(PK)-Tmax of Relma-cel
Time to maximum concentration of Relma-cel in peripheral blood
Measured: up to 1 year after Relma-cel infusion
Pharmacokinetic(PK)-AUC of Relma-cel
Area under the concentration vs time curve of Relma-cel
Measured: up to 1 year after Relma-cel infusion
Adverse events (AEs)
These adverse events would be measured by assessment scale method according to NCI-CTCAE v5.0 classification standard
Measured: up to 1 year after Relma-cel infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2024
- Study start15 Aug 2024
- Primary completion30 Apr 2025 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Hodgkin 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Ming Ju Biotechnology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Huilai Zhang, Principal investigator, Tianjin Cancer Hospital Airport Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06479356
- Sponsor's protocol ID
- JWCAR029-117
- Status last verified
- Aug 2024
- First submitted
- 24 Jun 2024
- Last updated
- 21 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Single-Arm Study of Relma-cel, CD19-targeted Chimeric Antigen Receptor (CAR)T Cells for Relapsed or Refractory (R/R) LBCL
- ClinicalTrials.gov ID
- NCT06479356
- Acronym / sponsor ID
- JWCAR029-117
- Conditions
- Non-Hodgkin Lymphoma, Large B-cell Lymphoma
- Keywords
- JWCAR029, B-Cell Malignancies, CAR T cells, Chimeric antigen receptor, Relapsed/Refractory
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Shanghai Ming Ju Biotechnology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 15 Aug 2024 (actual)
- Primary completion
- 30 Apr 2025 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 28 Jun 2024 (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 an open-label, single-arm study to treat the adult R/R Large B-cell Lymphoma subjects with Relmacabtagene autoleucel (relma-cel) in China.
Detailed description
This is an open-label, single-arm study conducted in adult subjects with R/R LBCL in China to evaluate efficacy，safety and pharmacokinetics(PK) of relma-cel.
Relma-cel was approved by the China National Medical Products Administration(NMPA)in September 2021(Acceptance No:CXSS2000036)for the treatment of adult patients with R/R LBCL after second-line or more systemic therapy.The recommended dose is 1×10^8 CAR+T cells.The indication for this application is R/R LBCL and the recommended dose is 1×10^8 CAR+T cells.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Relma-cel | Experimental | Biological: Relma-celEfficacy, safety and PK of Relma-cel will be evaluated in 1 x 10^8 CAR+T cells dose level |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- ≥18 years old;
- Sign on the informed consent;
- Subjects must have histologically confirmed Large B-cell Lymphoma;
- Subjects had been treated with anthracyclines and rituximab(or other CD20-targeted antibodies) and had relapsed, failed to respond, or progressed after at least two lines of therapy including autologous hematopoietic stem cell transplantation(auto-HSCT);
- Subjects have accessible PET-positive lesion and have measurable CT-positive lesion according to Lugano Classification;
Key exclusion criteria (11 listed)
- Primary CNS lymphoma;
- History of another primary malignancy that has not been in remission for at least 2 years;
- Subjects has HBV,HCV,HIV or syphilis infection at the time of screening;
- Active deep venous thrombosis(DVT)/Pulmonary embolism(PE),or active DVT/PE requires anti-coagulation within 3 months prior to signing the ICF;
- Subjects with uncontrolled systemic fungal,bacterial,viral or other infection;
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 |
|---|---|---|
| Relma-celAlso: CD19-targeted Chimeric Antigen Receptor(CAR) T CellsRelma-cel will be administered at one dose level:1×10^8 CAR+T cells | Biological | Relma-cel |
Primary outcome
Objective response rate (ORR) in LBCL subjects
Time frame: 3 months
Objective response rate (ORR) in 3 month evaluated by investigator of LBCL subjects
10 secondary outcomes
Objective response rate (ORR)
Time frame: 3 months
Best objective response rate ( Best ORR) in LBCL subjects
Time frame: up to 1 year after Relma-cel infusion
Complete response rate (CRR) in LBCL subjects
Time frame: up to 1 year after Relma-cel infusion
Progression-free survival (PFS)
Time frame: up to 1 year after Relma-cel infusion
Overall survival (OS)
Time frame: up to 1 year after Relma-cel infusion
Duration of response (DOR)
Time frame: up to 1 year after Relma-cel infusion
Pharmacokinetic(PK)-Cmax of Relma-cel
Time frame: up to 1 year after Relma-cel infusion
Pharmacokinetic(PK)-Tmax of Relma-cel
Time frame: up to 1 year after Relma-cel infusion
Pharmacokinetic(PK)-AUC of Relma-cel
Time frame: up to 1 year after Relma-cel infusion
Adverse events (AEs)
Time frame: up to 1 year after Relma-cel infusion
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 Aug 2024.
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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.
Huilai Zhang principal investigator
Tianjin Cancer Hospital Airport Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Relma-cel in people with Non-Hodgkin Lymphoma and 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 11 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 21 Aug 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Relma-cel Medical (+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?
Objective response rate (ORR) in LBCL subjects (time frame: 3 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 21 Aug 2024.