Relma-cel (JWCAR029) CD19 CAR-T Cell Therapy for Relapsed and Refractory Mantle Cell Lymphoma
A Phase 2 study evaluating Relma-cel, a CD19-directed CAR-T cell therapy, in adults with relapsed or refractory mantle cell lymphoma in China. CancerFax helps patients and families review eligibility, organise records, and coordinate with leading trial centres.
About This Clinical Trial
Mantle cell lymphoma is an aggressive subtype of B-cell non-Hodgkin lymphoma that often responds initially to chemoimmunotherapy and BTK inhibitors but tends to relapse. Patients who relapse after BTK inhibitors and chemotherapy face a particularly difficult clinical situation, with limited standard options and historically poor outcomes. This is the patient population most in need of newer, targeted approaches such as CAR-T cell therapy.
This Phase 2, open-label, single-arm, multicenter study evaluates Relma-cel (relmacabtagene autoleucel, also known as JWCAR029), an autologous CD19-directed CAR-T cell product developed by JW Therapeutics, in adults with relapsed or refractory mantle cell lymphoma. Patients receive a single infusion at a target dose of 1.0 × 10⁸ CAR-positive T cells after lymphodepleting chemotherapy, followed by structured short and long-term monitoring.
CD19 is widely expressed on B-cell malignancies including MCL, which makes it a logical target for engineered T-cell therapy. Relma-cel has already received approval in China for relapsed/refractory large B-cell lymphoma in 2021, and this study extends its clinical evaluation to MCL — an indication where CD19 CAR-T therapies such as brexucabtagene autoleucel have shown meaningful response rates in heavily pre-treated patients.
Published Phase 2 data for Relma-cel in R/R MCL have been reported in peer-reviewed oncology forums and have generated interest as part of the broader Chinese CAR-T landscape. The trial is currently in active follow-up rather than recruiting new patients; this page is intended to help patients and clinicians understand the study, the therapy, and the wider pathway to CD19 CAR-T treatment in China.
The primary question is the objective response rate at three months after Relma-cel infusion in adults with relapsed or refractory mantle cell lymphoma, alongside detailed safety, pharmacokinetic, and long-term survival measures.
Trial at a Glance
A quick snapshot of the trial. This is informational only and is not a confirmation that any individual patient is eligible.
Final eligibility is determined only by the trial investigators after reviewing complete medical records.
Treatment Being Studied
Relma-cel (JWCAR029, generic name relmacabtagene autoleucel) is an autologous CD19-directed CAR-T cell therapy. The patient's own T cells are collected, genetically modified to target a protein called CD19 on B-cell lymphoma cells, expanded in a manufacturing facility, and then infused back into the patient.
Once infused, the engineered T cells recognise and attack CD19-expressing lymphoma cells. In this trial, patients receive a single dose of 1.0 × 10⁸ CAR-positive T cells after a short course of lymphodepleting chemotherapy.
How CD19 CAR-T therapy works in mantle cell lymphoma
Mantle cell lymphoma cells carry CD19 on their surface. Relma-cel is built from the patient's own immune T cells, which are reprogrammed in a lab to carry a chimeric antigen receptor that locks on to CD19. After lymphodepleting chemotherapy clears the way, these engineered cells are infused back. They expand inside the body, find CD19-positive lymphoma cells, and destroy them. The same cells can also persist for months, providing an ongoing immune effect against the cancer.
T cells are collected from the patient's blood through a process called leukapheresis, usually over a few hours at the trial centre.
The collected T cells are sent to a GMP facility where they are genetically engineered to express the CD19 CAR, expanded, and quality tested. This typically takes a few weeks.
While the CAR-T product is being manufactured, the treating team may give bridging chemotherapy or targeted therapy to control disease, depending on the patient's status.
A short course of chemotherapy (typically fludarabine and cyclophosphamide) is given a few days before infusion to make space for the CAR-T cells to expand.
A single dose of approximately 1.0 × 10⁸ CAR-positive T cells is infused intravenously, usually as an inpatient procedure.
Patients are closely monitored in the hospital for cytokine release syndrome, neurological effects, and low blood counts. Long-term follow-up under this protocol extends up to 5 years after infusion.
Relma-cel is approved in China for other lymphoma indications. Its use in mantle cell lymphoma in this study is investigational. It is not a standard, approved treatment for MCL outside of authorised protocols.
Who This Trial May Be For
This trial was designed for adults with mantle cell lymphoma that has come back or has not responded to earlier treatments. The patient profile below describes the kind of patient the protocol was written for; it is not a substitute for formal screening.
Mantle cell lymphoma confirmed on tissue biopsy with appropriate pathology and immunohistochemistry, not a presumptive diagnosis.
Disease that has returned after prior therapy or has not responded adequately. Most patients in this setting have already received chemoimmunotherapy and a BTK inhibitor.
If the patient has previously received a CD19-directed therapy, the lymphoma must still express CD19 on confirmation testing.
ECOG performance status of 0 or 1, with expected survival of more than 12 weeks and adequate organ function for cell therapy.
Cases need review by a CAR-T-experienced lymphoma team to confirm fitness for apheresis, lymphodepletion, and inpatient CAR-T management.
International patients must be willing and able to travel to one of the trial sites in China and remain near the hospital for the apheresis, infusion, and early monitoring period.
Eligibility Criteria
These are the main eligibility criteria from the registered trial protocol. Meeting some criteria does not guarantee enrollment, and the final decision always rests with the trial investigators after full medical review.
check_circleInclusion Criteria — May Be Eligible
- ✓Age 18 years or older
- ✓Signed informed consent
- ✓Histologically confirmed mantle cell lymphoma
- ✓Relapsed or refractory disease
- ✓Accessible PET-positive lesion and measurable CT-positive lesion according to Lugano Classification
- ✓ECOG performance status of 0 or 1
- ✓Expected survival greater than 12 weeks
- ✓Adequate organ function
- ✓Adequate vascular access for leukapheresis procedure
- ✓If previously received CD19-targeted therapy, lymphoma lesions must still express CD19
- ✓Women of childbearing potential must use highly effective contraception for 1 year after the last dose of JWCAR029
- ✓Males with partners of childbearing potential must use an effective barrier contraceptive method for 1 year after the last dose of JWCAR029
cancelExclusion Criteria — May Not Be Eligible
- ×CNS-only involvement by malignancy or primary CNS lymphoma
- ×History of another primary malignancy not in remission for at least 2 years
- ×Active HBV, HCV, HIV, or syphilis infection at screening
- ×Deep venous thrombosis or pulmonary embolism, or DVT/PE requiring anti-coagulation within 3 months prior to signing the informed consent
- ×Uncontrolled systemic fungal, bacterial, viral, or other infection
- ×Acute or chronic graft-versus-host disease (GVHD)
- ×History of serious cardiovascular disease or clinically relevant CNS pathology
- ×Pregnant or nursing women
- ×Use of chemotherapy, corticosteroids, experimental agents, GVHD therapies, radiation, or other lymphoma therapies without an appropriate wash-out period before leukapheresis
- ×Prior allogeneic hematopoietic stem cell transplantation
- ×Uncontrolled medical conditions or inability to follow protocol procedures
- ×Prior CAR-T cell therapy or other genetically modified T-cell therapy
Criteria here are illustrative. The trial protocol has its own detailed list. CancerFax can help organize records for review, but only the trial center can confirm participation.
Medical Records and Tests Needed for Review
Complete and well-organised records make trial eligibility review much faster and more accurate. CancerFax helps families gather, translate, and summarise these documents before they are sent to the trial centre.
How the Trial Process May Work
CAR-T cell therapy trials involve more steps than most lymphoma trials because the treatment is manufactured from the patient's own cells. The general flow below shows what international patients can expect.
CancerFax helps gather medical records, translate them where needed, and request a preliminary review by the relevant trial centre or CAR-T team in China.
The trial centre reviews diagnosis, prior therapy, performance status, and key labs and indicates whether the patient may be suitable for formal screening.
Patients travel to the trial centre for in-person evaluation, fresh imaging, repeat labs, infectious disease screening, cardiac testing, and confirmation of CD19 status if relevant.
If the patient passes screening, the trial team explains the protocol, risks, costs, and follow-up requirements in detail before formal consent.
T cells are collected, the CAR-T product is manufactured over several weeks, lymphodepleting chemotherapy is given, and Relma-cel is then infused as an inpatient.
Patients are closely monitored as inpatients during the early post-infusion period for CRS and neurologic effects. Structured follow-up under this protocol continues for up to 5 years.
Potential Benefits
For some patients with relapsed or refractory mantle cell lymphoma, clinical trials of CD19 CAR-T therapy may offer access to investigational treatments and specialist care that are not yet broadly available. The points below describe what trial participation may offer; they are not a promise of clinical response.
Relma-cel is investigational for MCL outside this protocol. Trial participation can provide structured access to a CD19 CAR-T option for heavily pre-treated patients.
Trial sites such as the Institute of Hematology (CAMS), Fudan Shanghai Cancer Center, and Peking University Cancer Hospital have substantial experience in lymphoma and CAR-T management.
Patients are followed under a structured protocol with frequent labs, imaging, and clinical reviews, which can pick up complications early.
CD19 expression and other biomarkers are confirmed before therapy, helping select patients most likely to respond to a CD19-directed approach.
Data from this study informs how Relma-cel and similar CD19 CAR-T products are used for MCL in China and globally.
The protocol sets out apheresis, manufacturing, lymphodepletion, infusion, and follow-up steps in a structured way, which can make planning and travel logistics clearer.
A clinical trial may or may not directly benefit the individual patient. Responses to CAR-T therapy vary, and realistic expectations should be discussed with the treating team and the family.
Risks and Side Effects
All CAR-T trials carry potential risks specific to cell therapy. The risks below are based on the known safety profile of CD19 CAR-T products and should be reviewed carefully with the treating oncologist and the trial team.
An immune response causing fever, low blood pressure, low oxygen, and organ stress. It usually appears within days of infusion. Trial centres treat it with supportive care, tocilizumab, and steroids when needed.
Lymphodepleting chemotherapy and the CAR-T effect can cause prolonged low neutrophils, low platelets, and low haemoglobin, increasing the risk of infection and bleeding.
Confusion, language difficulty, tremor, drowsiness, or, rarely, seizures. Usually short-lived but requires close inpatient monitoring and specific management.
CD19 CAR-T also depletes normal B cells, which can lead to low antibodies and a higher risk of infection. Some patients need long-term immunoglobulin replacement and vaccination planning.
Common but usually manageable: fatigue, nausea, fever, anaemia, and infections, particularly during the period of low blood counts.
Long-term risks of CD19 CAR-T therapy, including rare secondary malignancies, are still being studied. Follow-up under this protocol extends for several years.
Travel burden, time away from home, no guaranteed clinical benefit, and the possibility of disease progression during manufacturing or screening are all real factors that should be discussed with the family and the treating team.
Trial Location and Hospital Information
This study is being conducted across 12 hospitals in China, including major lymphoma and haematology centres in Beijing, Shanghai, Tianjin, Hangzhou, Zhengzhou, Nanjing, Guangzhou, and Fuzhou. Notable sites include the Institute of Hematology of the Chinese Academy of Medical Sciences in Tianjin, Fudan University Shanghai Cancer Center, Peking University Cancer Hospital, and Zhongshan Hospital affiliated to Fudan University.
International patients exploring CAR-T therapy in China usually need translated and well-organised medical records, a remote case review with the trial or treatment centre, a medical visa, accommodation near the hospital for the apheresis and post-infusion monitoring period, and on-the-ground coordination including interpreter support. CancerFax helps families plan and manage each of these steps.
Costs, Trial Coverage, and Patient Expenses
Costs in CAR-T trials vary by site, sponsor, and whether the patient is local or international. Specific cost coverage for this study has not been confirmed in writing on this page, so the table below describes the typical pattern for sponsored CAR-T trials of this kind.
CancerFax helps families understand the expected cost categories for CAR-T in China and asks the trial or treating centre for written confirmation of what is covered before any travel commitment.
Standard Treatment vs Clinical Trial
Patients with relapsed or refractory mantle cell lymphoma have several options including BTK inhibitors, chemoimmunotherapy, and CAR-T therapy. The table below compares standard treatment and trial participation in broad terms; the right choice depends on the individual case.
How CancerFax Helps Patients Explore This Trial
CancerFax is a specialist cancer patient-navigation and advanced cancer treatment access platform. For families exploring CAR-T therapy in China, we help organise the medical picture, guide the conversation with trial centres, and make complex cross-border treatment journeys easier to manage.
We help families gather pathology, imaging, and treatment history, and prepare a clear summary that a CAR-T team can review quickly.
We compare the patient's case against the trial criteria and similar CAR-T pathways in China, and flag missing tests such as CD19 expression confirmation early.
We coordinate with leading lymphoma and CAR-T centres in China and share records in the format their teams expect.
We help with medical visa documentation, accommodation near the hospital, transfers, and timing around apheresis and infusion.
If a particular trial is closed or unsuitable, we help families explore other CD19 CAR-T options, second opinions, and approved therapies.
From the first conversation through manufacturing, infusion, and follow-up, our team stays in touch with the family and the treating centre.
CancerFax does not guarantee trial enrollment, treatment response, or outcome. Our role is to help patients access accurate information and appropriate pathways.
Questions to Ask Before Considering This Trial
These are useful questions to take into a conversation with the trial team and the treating oncologist. They are designed to help patients and families make a well-informed decision.
Frequently Asked Questions
Want to Know Whether This Trial or Another CD19 CAR-T Pathway May Be Relevant?
CancerFax can review the case, help organise documents, and coordinate with leading lymphoma and CAR-T centres in China. We help families understand what is realistic, what is investigational, and what the next sensible step might be.
The information on this page is for educational and patient-navigation purposes only. It does not replace medical advice, diagnosis, or treatment from a qualified physician. Clinical trial eligibility, enrollment, treatment decisions, and costs are determined only by the trial investigators, hospital, sponsor, and applicable regulations. CancerFax helps patients and families understand options and coordinate case review where appropriate, but does not guarantee trial acceptance, treatment response, or clinical outcome. All clinical decisions must be made in consultation with a qualified, licensed physician with access to the patient's complete medical information.
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© CancerFax · Specialist cancer access and patient-navigation platform. CancerFax is not a medical institution, hospital, or clinical trial sponsor. Trial details may change; always confirm current eligibility, status, and costs directly with the trial center.