JCXH-213: The World's First mRNA-LNP Based In Vivo CAR Therapy for Relapsed / Refractory B-cell Non-Hodgkin Lymphoma
NCT06618313 is a first-in-human dose-escalation study evaluating JCXH-213 — Immorna's mRNA-LNP based in vivo CAR therapy targeting CD19 — in patients with relapsed or refractory B-cell non-Hodgkin lymphoma. Unlike conventional CAR-T therapy, JCXH-213 requires no leukapheresis, no ex vivo cell manufacturing, and no lymphodepletion chemotherapy. It is administered as a standard intravenous infusion that reprograms the patient's own T cells, NK cells, and macrophages directly inside the body. The trial is recruiting at Beijing GoBroad Hospital under the leadership of Dr. Kai Hu. This represents a genuinely new era of programmable immunotherapy. CancerFax helps eligible international patients navigate access.
About This Clinical Trial
Relapsed or refractory B-cell non-Hodgkin lymphoma (r/r B-NHL) — encompassing diffuse large B-cell lymphoma (DLBCL), follicular lymphoma (FL), primary mediastinal large B-cell lymphoma (PMBCL), high-grade B-cell lymphoma (HGBCL), and transformed B-cell lymphomas — represents one of the most challenging therapeutic scenarios in haematological oncology. Approved ex vivo CD19 CAR-T therapies (axicabtagene ciloleucel, tisagenlecleucel, lisocabtagene maraleucel) have transformed outcomes for eligible r/r B-NHL patients, achieving complete remission rates of 40–60% in pivotal trials. Yet the real-world reach of ex vivo CAR-T remains severely constrained: leukapheresis requires a dedicated GMP apheresis facility; cell manufacturing takes 2–4 weeks and costs $350,000–$500,000 per patient in Western markets; lymphodepletion chemotherapy hospitalises the patient for at least a week; and patients with rapidly progressive disease may deteriorate beyond eligibility during the manufacturing wait.
NCT06618313 evaluates JCXH-213 — developed by Immorna (Jiachen Xihai Biotechnology Co., Ltd., Hangzhou, China) — the world's first mRNA lipid nanoparticle (LNP) based in vivo CAR therapy to enter human clinical trials. On March 30, 2025, Immorna announced the successful first-in-human dosing of JCXH-213, marking what the company describes as the world's first human application of an mRNA-LNP based in vivo CAR therapy. The trial is sponsored by Beijing GoBroad Hospital — one of China's highest-volume CAR-T centres — with Ruijin Hospital (Shanghai) listed as a collaborator. The investigator contact is Dr. Kai Hu, Director of the Lymphoma and Myeloma Research Center at Beijing GoBroad Hospital.
JCXH-213 uses Immorna's proprietary tLCNP (targeted Lipid Complex Nanoparticle) delivery platform — lipid nanoparticles conjugated to a CD8 nanobody designed to preferentially bind and transfect CD8-positive T cells in vivo. After IV infusion, the tLCNPs deliver CAR-encoding mRNA directly to the patient's circulating immune cells — including T cells, NK cells, and macrophages — which then produce the CD19-targeting CAR construct internally, equipping themselves with anti-tumour cytotoxic capability without ever leaving the body. The mRNA is transient (not genomically integrated), enabling re-dosing and dramatically reducing the risk of insertional mutagenesis or secondary malignancy from permanent genetic modification.
In April 2026, Immorna published the first clinical data from JCXH-213 — in a patient with systemic sclerosis treated on a separate autoimmune trial (NCT06564194). After a single low-dose administration, complete peripheral blood B-cell depletion was achieved and sustained throughout the two-week observation window. Lymph node biopsy confirmed deep tissue B-cell depletion as well — marking the first reported evidence of lymph node B-cell depletion with any in vivo CAR-T approach globally. No cytokine release syndrome and no liver enzyme abnormalities were observed. These data, while from a single patient with an autoimmune indication, provide the first human biological proof of concept for the tLCNP delivery platform. The B-NHL trial (NCT06618313) is enrolling patients with CD19-positive r/r B-NHL using the same platform.
JCXH-213 is not an iteration of existing CAR-T therapy. It represents a categorical platform shift: from ex vivo cell engineering to in vivo mRNA programming of immune cells — delivered like a drug, without apheresis, without a manufacturing wait, and without lymphodepletion chemotherapy.
Trial at a Glance
Key registry details for NCT06618313. This is a very small first-in-human exploratory dose-escalation study. Only 8 patients are planned across 4 dose cohorts. Eligibility is determined only by the trial investigators after full record review.
This is a first-in-human exploratory study with only 8 estimated participants. Places in each dose cohort are very limited. Early inquiry through CancerFax is strongly recommended for patients who may be eligible.
Treatment Being Studied
JCXH-213 is administered as an intravenous infusion — analogous in simplicity to giving a patient a monoclonal antibody. What happens after infusion is where the biology becomes extraordinary.
The tLCNP nanoparticles, after entering the bloodstream, use their CD8 nanobody surface ligands to identify and bind specifically to CD8+ cytotoxic T cells. The nanoparticles are then internalised by those T cells, releasing their mRNA payload into the cytoplasm. The T cells' ribosomes translate this mRNA into the CAR protein — a chimeric antigen receptor that binds CD19, the surface marker expressed on virtually all B-cell malignancies. Now armed with the CAR receptor, these T cells — still residing in the patient's body — begin seeking and destroying CD19-positive lymphoma cells.
How the therapy works (in simple terms)
How it is given
Patients must have histopathologically confirmed CD19-positive B-cell NHL per WHO 2022 criteria, measurable disease by Lugano 2014 criteria, and ECOG performance status of 0 or 1. CD19 positivity is mandatory — it is the target of the CAR construct. Records are reviewed and eligibility is confirmed by the trial team.
Eligible patients are assigned to one of 4 dose escalation cohorts using an accelerated titration combined with a standard 3+3 design. This means the first cohorts receive lower doses with rapid escalation if no safety signals emerge, and once dose-limiting toxicities are observed or expected, the conventional 3+3 safety evaluation structure governs subsequent cohorts.
JCXH-213 is administered as an IV infusion. No prior leukapheresis is required. No lymphodepletion chemotherapy is required. The mRNA-LNP tLCNP nanoparticles enter the bloodstream and preferentially transfect CD8+ T cells, NK cells, and macrophages — delivering the CD19 CAR-encoding mRNA payload directly to the patient's circulating immune cells.
After infusion, the patient's own immune cells produce the CD19-targeting CAR receptor. These freshly CAR-armed cells then circulate and engage CD19-positive lymphoma targets. The primary safety endpoint — dose-limiting toxicity (DLT) — is assessed over the 21 days following first infusion. Patients are monitored for safety, tolerability, immune activation markers, and tumour response.
After the 21-day DLT observation period, patients without major safety problems and who may continue to benefit are allowed to receive additional JCXH-213 infusions — reflecting the re-dosable nature of the mRNA platform. Follow-up for safety and efficacy continues through primary completion in August 2026.
Because JCXH-213 does not require lymphodepletion chemotherapy, patients may be able to receive this therapy without the week-long hospitalisation and bone marrow suppression that makes ex vivo CAR-T therapy so intensive. The safety profile will be characterised during this first-in-human trial.
Who This Trial May Be For
This is an extremely small first-in-human study — only 8 patients are planned. Eligibility criteria are published but limited detail is available beyond the registry. The following profiles reflect what is known from the registry listing. Only the trial team at Beijing GoBroad Hospital can confirm eligibility after reviewing full records.
This is a mandatory eligibility requirement. Eligible subtypes include: diffuse large B-cell lymphoma not otherwise specified (DLBCL NOS), follicular lymphoma (FL), histologically transformed DLBCL, primary mediastinal large B-cell lymphoma (PMBCL), and high-grade B-cell lymphoma (HGBCL). CD19 positivity must be confirmed by pathology or flow cytometry — patients with CD19-negative disease are not eligible.
Patients must have relapsed (disease returned after achieving remission) or refractory (disease never responded to treatment) B-cell NHL. The specific number of prior lines required is not stated in the registry — but in the context of a Phase I safety trial and the eligibility description, patients are likely to have failed at least 2 prior lines of systemic therapy. ⚠ VERIFY: Minimum prior line requirement with the trial team.
The eligibility criteria require an ECOG performance status of 0 (fully active) or 1 (restricted in physically strenuous activity but ambulatory). ECOG 2 or higher is not eligible. This is a stricter performance status requirement than some standard r/r B-NHL trials, reflecting the exploratory first-in-human nature of the study.
Patients must have at least one measurable lesion: nodal lesion with long axis > 15 mm, or extra-nodal lesion with both long and short axes > 10 mm. At least one measurable target lesion is required to assess treatment response throughout the study.
As with all interventional oncology trials, a minimum life expectancy of at least 3 months is required to allow the DLT observation window and initial follow-up to be completed meaningfully.
Patients must be 18 years or older. The registry states no maximum age. Prior malignancy within 5 years (except adequately treated carcinoma in situ, skin cancers, localised prostate, DCIS, or thyroid cancers) is an exclusion criterion.
Eligibility Criteria
The following criteria are taken directly from the ClinicalTrials.gov registry for NCT06618313. The registry provides limited detail — additional protocol-level criteria beyond what is listed here may apply. Only the trial investigators can confirm eligibility after reviewing complete medical records.
check_circleInclusion Criteria — May Be Eligible
- ✓Cytologically or histopathologically confirmed CD19-positive B-cell NHL per WHO 2022 criteria, including DLBCL NOS, follicular lymphoma (FL), histologically transformed DLBCL, primary mediastinal large B-cell lymphoma (PMBCL), high-grade B-cell lymphoma (HGBCL), and other eligible B-cell NHL subtypes
- ✓ECOG performance status 0 or 1
- ✓Measurable disease per Lugano 2014 criteria: nodal lesions with long axis > 15 mm (short axis measurable), or extra-nodal lesions with both long and short axes > 10 mm
- ✓Life expectancy greater than 3 months
- ✓Age 18 years and above
- ✓At least one prior line of systemic therapy (minimum prior line requirement: ⚠ VERIFY with trial team)
- ✓Any prior anti-tumour therapy completed at least 4 weeks before enrollment
cancelExclusion Criteria — May Not Be Eligible
- ×Other malignant tumours within 5 years before screening (except: adequately treated cervical carcinoma in situ, basal cell or squamous cell skin cancer, locally treated prostate cancer, radical DCIS, or radical thyroidectomy)
- ×B-cell NHL with active primary or secondary central nervous system (CNS) involvement
- ×Life expectancy less than 3 months
- ×ECOG performance status 2 or higher
The registry eligibility section for NCT06618313 is abbreviated. This is common for very early exploratory studies. CancerFax can help prepare records for submission but only the trial team can confirm protocol-level eligibility criteria and confirm participation.
Medical Records and Tests Needed for Review
To begin the eligibility review process, CancerFax will need the following documents. CD19 confirmation is the single most important eligibility document for this trial.
How the Trial Process May Work
Because JCXH-213 does not require leukapheresis or lymphodepletion, the treatment timeline and clinical experience is dramatically simpler than ex vivo CAR-T therapy. However, as a first-in-human study at a single centre in Beijing, international patients will need to plan for on-site visits.
Potential Benefits
These reflect both the scientific rationale of JCXH-213 and the practical advantages it may hold over ex vivo CAR-T therapy. Clinical outcomes in this specific trial are unknown — this is a first-in-human safety study.
Conventional ex vivo CAR-T requires 2–4 weeks of cell manufacturing after leukapheresis. During this time, patients with aggressive r/r B-NHL often receive bridging chemotherapy and may deteriorate. JCXH-213 eliminates the manufacturing wait — it can be administered as soon as the drug vial is available, with no patient-specific production process.
Leukapheresis — the large-volume blood draw and T cell collection procedure — requires specialist equipment, technical expertise, and carries risks including haemorrhage, line complications, hypocalcaemia, and cardiovascular stress. JCXH-213 requires only a standard IV line, removing this barrier entirely.
Cyclophosphamide and fludarabine lymphodepletion — standard before all approved ex vivo CAR-T therapies — produces severe immunosuppression, prolonged cytopenias, infectious complications, and requires 5–7 days of inpatient hospitalisation. If JCXH-213 proves effective without lymphodepletion (as its mechanism suggests), it would eliminate this entire toxic phase.
mRNA is transient by nature — it is produced, translated, and degraded without entering the nucleus or integrating into the genome. Unlike lentiviral or retroviral vector-based ex vivo CAR-T (which permanently alters T cell DNA), JCXH-213's mRNA payload does not create permanent genetic modifications — reducing the theoretical risk of insertional mutagenesis or secondary malignancies from vector integration.
Because JCXH-213 is administered as a pharmaceutical product without patient-specific manufacturing, repeat doses can be given as needed — a capability that is practically and economically impractical with ex vivo CAR-T. This opens the possibility of maintaining or restoring CAR-T activity over time as the initial mRNA expression fades.
Published preclinical data indicate that JCXH-213 can deliver CAR constructs to not only T cells but also NK cells and macrophages in vivo. This multi-cellular CAR response — with three distinct effector populations simultaneously targeting CD19 — may produce synergistic anti-tumour activity not achievable with ex vivo CAR-T products that engineer only one cell type.
April 2026 data from the autoimmune programme confirmed complete peripheral blood and lymph node B-cell depletion after a single low-dose administration of JCXH-213, with no CRS and no liver enzyme abnormalities in the single reported patient. While this is very limited data from an autoimmune context, it provides the first human evidence that the tLCNP platform achieves its intended biological activity in vivo.
The most transformative potential of JCXH-213 is not just efficacy — it is accessibility. An in vivo mRNA CAR therapy that requires no leukapheresis and no lymphodepletion could reach patients in hospitals that cannot perform GMP cell manufacturing, in countries where approved ex vivo CAR-T products are unavailable or unaffordable, and in patients who cannot survive the 3–5 week manufacturing wait.
Risks and Side Effects
JCXH-213 is in its first human clinical study. The safety profile for an mRNA-LNP in vivo CAR therapy in cancer patients is not yet established. The following reflects the known and theoretical risk categories — not confirmed adverse event data from this trial.
JCXH-213 represents a genuinely new class of therapy. While mRNA-LNP technology has an established safety record in the vaccine context (COVID-19 mRNA vaccines), the delivery of CAR-encoding mRNA to T cells in a cancer patient — at therapeutic doses sufficient to generate anti-tumour immune activity — has not been characterised in humans before this trial. The 21-day DLT window is specifically designed to identify unexpected safety signals.
CD19-targeted immune activation — whether from ex vivo or in vivo CAR approaches — carries the risk of cytokine release syndrome (CRS), which can range from mild fever to severe cardiovascular and respiratory compromise. The first reported patient data from JCXH-213 (autoimmune indication, April 2026) showed no CRS after a single low dose — a promising early signal, but cancer patients receiving escalating doses targeting a higher tumour burden may have different cytokine responses.
CD19 is expressed on both malignant and normal B lymphocytes. Effective CD19-targeting will deplete normal B cells (B-cell aplasia), reducing the patient's ability to produce antibodies and increasing susceptibility to infections. This is an expected and manageable consequence of CD19-targeted CAR therapy — patients typically require immunoglobulin replacement therapy. Duration of B-cell aplasia with the transient mRNA approach may be shorter than with ex vivo CAR-T, but this is not yet established.
Lipid nanoparticle infusion can cause infusion-related reactions including fever, chills, hypotension, and in rare cases anaphylaxis. Pre-medications are typically used to minimise these risks. The tLCNP formulation specific to JCXH-213 has not been characterised at cancer therapeutic doses in humans prior to this trial.
Immune effector cell-associated neurotoxicity syndrome (ICANS) — neurological symptoms including confusion, aphasia, somnolence, and in severe cases cerebral oedema — is a known complication of ex vivo CD19-targeting CAR-T therapy. Whether and to what degree JCXH-213 produces ICANS at therapeutic doses is unknown and will be assessed during this trial. CNS involvement with active lymphoma is an exclusion criterion, reducing but not eliminating this risk.
A major mechanism of resistance to ex vivo CD19-directed CAR-T therapy is CD19 antigen escape — downregulation or loss of CD19 expression on lymphoma cells under the selective pressure of CD19-targeted therapy. This is a risk with any CD19-targeting approach. Immorna's multi-cellular CAR platform (T cells, NK cells, macrophages simultaneously) may provide some resistance to pure CD19-negative escape, but this has not been clinically demonstrated.
The trial is conducted at the Department of Lymphoma and Myeloma, Beijing GoBroad Hospital (Changping District, Beijing). International patients must travel to Beijing for screening, infusion, and the 21-day DLT observation period. Whether continued follow-up can be managed remotely after the initial observation window should be confirmed with the trial team. CancerFax supports all logistics for international patients.
The primary purpose of this trial is to determine whether JCXH-213 is safe and what dose produces dose-limiting toxicity. Risks specific to this new platform are not yet fully characterised. All participants receive close monitoring by an experienced lymphoma team. Patients should understand they are participating in the very first human assessment of this technology.
Trial Location and Hospital Information
NCT06618313 is conducted at the Department of Lymphoma and Myeloma at Beijing GoBroad Hospital, located on Yuhengnan Road, Changping District, Beijing, China. The investigator contact is Dr. Kai Hu (Director, Lymphoma and Myeloma Research Center). Ruijin Hospital (Shanghai) is listed as a collaborator institution.
Beijing GoBroad Hospital has excellent infrastructure for international patients — with English-speaking patient coordinators, documented international patient programmes, and active international research collaborations including with the NIH and multiple global academic institutions. The hospital's CAR-T centre is one of the most experienced in Asia. CancerFax has experience coordinating access for international patients at this institution and provides full logistics support: medical visa guidance, accommodation near the Changping campus, interpreter services, and caregiver logistics.
Costs, Trial Coverage, and Patient Expenses
As a sponsored first-in-human exploratory trial, the investigational drug product (JCXH-213) is provided by Immorna at no direct cost to participants within the trial protocol. However, travel, accommodation, and non-protocol costs are the patient's responsibility.
One of the most significant promises of in vivo mRNA-based CAR therapy is dramatically lower per-patient cost. Immorna's tLCNP manufacturing process produces 3,000+ doses per batch — compared to one patient's worth of cells for ex vivo CAR-T. Within this trial, the drug cost is covered by the sponsor. Future commercial costs will depend on clinical development outcomes.
Standard Treatment vs Clinical Trial
This comparison is for educational purposes. JCXH-213 is investigational — this comparison illustrates the platform differences, not comparative clinical efficacy. Treatment decisions must be made with your haematologist or oncologist.
How CancerFax Supports You
CancerFax is a global cancer navigation platform. This is one of the most scientifically significant trials in our portfolio — a genuine first-in-human platform with the potential to transform how CAR therapy is delivered globally. We take its navigation seriously.
Our medical team reviews your pathology reports, CD19 expression status, WHO 2022 histological classification, prior treatment lines, measurable disease documentation, and ECOG assessment to map your case against the published eligibility criteria — including the CD19-positivity requirement that is the single most important eligibility gate for this trial.
Patients who have previously received ex vivo CD19-directed CAR-T therapy or bispecific antibodies may have experienced CD19 antigen escape. CancerFax can advise on whether a repeat biopsy for CD19 re-confirmation is needed before submitting your records, and help frame your prior CAR-T history in the context of this trial's eligibility.
CancerFax contacts the trial team (Dr. Kai Hu's department, Beijing GoBroad Hospital) on your behalf, submits a structured medical summary, and facilitates the initial eligibility dialogue. Given only 8 patients are planned, we prioritise early and organised communication for potentially eligible patients.
One of JCXH-213's advantages is the absence of a manufacturing wait. If you are eligible, there is no multi-week delay before treatment can begin — unlike ex vivo CAR-T. CancerFax can help compress the time between first inquiry and on-site screening for patients with aggressive disease.
The trial is at Beijing GoBroad Hospital's Changping District campus (Yuhengnan Road). CancerFax provides visa guidance, accommodation near this campus, interpreter coordination, and caregiver logistics. We are familiar with GoBroad's international patient process.
If you are not eligible for this specific trial — because of CD19-negative disease, ECOG performance status, CNS involvement, or other criteria — CancerFax can identify alternative r/r B-NHL trials at GoBroad and globally, including the LUCAR-E9D/E9K dual CD19/CD20 trial (NCT07093411) also at Beijing GoBroad Hospital, and other approved CAR-T access pathways.
CancerFax does not guarantee trial enrollment, treatment response, or outcome. This is an 8-patient first-in-human safety study. We help eligible patients access the process — we do not create access where eligibility criteria are not met.
Questions to Ask Before Considering This Trial
If you speak with Dr. Kai Hu's team at Beijing GoBroad Hospital or discuss this trial with your haematologist, these questions will help guide the conversation.
Frequently Asked Questions
Ready to Explore the World's First mRNA In Vivo CAR Therapy Trial?
Only 8 patients will be enrolled in this landmark first-in-human study. If you have relapsed or refractory CD19-positive B-cell NHL and meet the eligibility profile, CancerFax can help you access this trial before places fill. Submit your records for a no-obligation medical review today.
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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