In Vivo CAR-T/NK in China: Can Lentiviral or Non-Viral Delivery Take the Lead? Insights from ASGCT 2026
PersonGen
Developer of Tumor Cell Immunotherapy Technologies and Products
May 25, 2026
eMedClub News
At the recently concluded ASGCT 2026 Annual Meeting, in vivo CAR-T（in vivo CAR-T）Becoming one of the most prominent focal points. Compared with traditional ex vivo CAR-T therapy, this therapy does not require ex vivo cell modification or lymphodepletion chemotherapy. Therapeutic CAR-T cells can be directly generated in the patient's body through intravenous injection, which is expected to push cell therapy from "personalized customization" towards "off-the-shelf accessibility."
At this year's conference, multiple Chinese companies showcased new advancements in their in vivo CAR-T/NK pipelines, covering two major technological approaches: lentiviral vectors and LNP-mRNA. These pipelines address dual indications, including cancer and autoimmune diseases. Below are representative pipeline updates.(Incomplete statistics, ranking不分先后)。
Bo sheng ji
The CD7-VHH Heavy-Targeting Lentivirus In Vivo CAR Generation Platform Developed by Bo Sheng Ji Medicine Science and Technology (Suzhou) Co., LTDThe world's first lentivirus technology capable of efficiently transducing both resting T cells and NK cells simultaneously. This platform fundamentally avoids the inflammatory risks caused by pre-activation of T cells, and can simultaneously generate CAR-T and CAR-NK cells in vivo, exerting synergistic anti-tumor effects. It is also highly versatile and scalable.
LV009 Injection for B-cell Malignancies: Key Preclinical Data Shows GMP-grade LV009 Achieves a Transfection Efficiency of Over 50% in Resting T Cells from Both Healthy Donors and Patient-derived Samples, with Transfection Efficiency Unaffected by Human Serum; Simultaneously Generates CAR-T and CAR-NK Cells, a Function Not Yet Achieved by Other Global In Vivo CAR Technologies; Transfection Strictly Depends on CD7 Expression, with No Off-target Effects Observed in Non-target Cells Such as Primary B Cells.
In humanized tumor-bearing mouse models, a single intravenous injection of LV009 efficiently generated CAR-T cells in vivo. The CAR cells reached their peak expansion 15-20 days after administration, showing pharmacokinetic characteristics comparable to those of CAR-T cells prepared in vitro. They significantly inhibited tumor growth and extended the survival period of the mice. The virus was metabolized within 2 hours in vivo, with no off-target toxicity or histopathological damage found in vital organs such as the liver.
LV091 Injection for autoimmune diseases. In vitro experiments confirmed that the CD19/PD1 bispecific CAR-T cells generated by LV091 exhibited significant and sustained specific cytotoxicity against both CD19⁺ target cells and PD1⁺ target cells. Patient samples showed，LV091 CanEffective enough to clear systemic lupus erythematosus（SLE）B cells in the patient's peripheral blood, while specifically depleting the PD1⁺ T cell subset, exhibit targeted specificity in cytokine release.
In humanized mouse models, a single intravenous infusion of LV091 not only significantly inhibited the growth of CD19⁺ tumors but also effectively eliminated overactivated PD1⁺ T cells; no obvious toxic reactions were observed throughout the experiment, and the mice maintained stable body weight.
Hope Bio
Hope Bio(Yimiao Biotechnology Incubation Enterprise)Development of a Third-Generation, Self-Inactivating, Replication-Defective Lentiviral Vector for Intravenous Administration to Achieve In Vivo CD19 CAR-T Cells（IV01）The generation. This vector uses the Cocal virus envelope with a precise T-cell targeting module, significantly enhancing transduction efficiency while avoiding off-target modifications to non-T cells such as B cells and monocytes.
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In vitro studies have shown that IV01 can rapidly induce T-cell activation and efficiently express CAR, while showing low transduction in non-T immune subsets. Compared with traditional in vitro CD19 CAR-T cells, CAR-T cells generated by IV01 exhibit stronger cytotoxic activity and persistence. In mouse models bearing CD19⁺ xenograft tumors, a single injection of IV01 led to dose-dependent in vivo generation and expansion of CAR-T cells, achieving rapid and sustained tumor clearance without off-target transduction or organ toxicity.
Yi Ming Bio
Yiming Biotechnology has developed a novel in vivo CAR-T platform mediated by Cocal-G envelope and CD7 nanobody. Lentiviral vectors encoding BCMA or CD19 CAR were produced in 293TH suspension cells to transduce activated human PBMC.
The results showed that the engineered lentiviral vector achieved high yields, with an upstream titer of 4×10⁸ TU/mL in activated PBMCs and a final product titer of 2×10⁸ TU/mL. At an MOI of 1.0, the CD7-targeted lentiviral vector demonstrated a transduction efficiency of approximately 80% in T cells. The generated CAR-T cells exhibited over 80% cytotoxicity against multiple myeloma and lymphoma target cells in vitro. A single intravenous injection of 5×10⁶ TU significantly reduced tumor burden in NSG mouse models.
Gravel Biotechnology
Grit Bio GT860 is an in vivo dual-target CAR-T delivered through T cell-targeting lentivirus. The platform utilizes a mutated VSV-G fusogen combined with optimized T cell-binding ligands to precisely target T cells, reduce off-target delivery, and enhance transduction efficiency. Its unique CAR-IGNITE enhancer design helps T cells resist immunosuppression, boosting proliferation and tumor-killing capabilities; dual-target CAR structure.(For multiple myeloma)Aimed at reducing the risk of immune escape and recurrence.
In the NOG mouse model, a single intravenous injection of GT860 as low as 2×10⁶ TU maintained robust CAR expression by Day 30; in the RPMI8226 tumor model, a single dose induced potent anti-tumor activity and significant CAR-T expansion, demonstrating its superior in vivo adaptability and antigen-driven efficacy. Comprehensive histopathological evaluation showed no systemic toxicity in any of the examined organs.
Hongxin Biotechnology
HN2301 is the world's first LNP-targeted in vivo CAR-T candidate drug to enter human clinical trials, and its core consists of proprietary ionizable amino lipids with independent intellectual property rights.（ILB-3132）Humanized CD8-targeting antibody fragments and Anti-CD19 CAR mRNA. Recent studies have confirmed that HN2301 can generate CD19-targeted CAR-T cells in SLE patients, achieving deep depletion of peripheral and tissue B cells, inducing immune resetting and long-lasting clinical remission.
The study enrolled 6 patients with moderate to severe SLE, utilizing a dosing regimen of once every two days for a total of five administrations, with immunosuppressants discontinued one week prior to the first infusion. Results showed that peripheral blood B cells significantly decreased within 6 hours after the first infusion and completely disappeared after 1-2 infusions; analysis of inguinal lymph node biopsy and bone marrow aspiration samples from two patients confirmed complete depletion of tissue CD19⁺ B cells post-treatment; levels of disease-related autoantibodies, including anti-dsDNA, normalized or significantly decreased within 3 months after infusion, and the Systemic Lupus Erythematosus Disease Activity Index 2000 scores were markedly reduced in all patients; no high-grade CRS or ICANS was observed.
West Lake Bio
West Lake Bio has developed the mRNA–LNP–Ery red blood cell-mediated mRNA delivery platform. This platform covalently conjugates mRNA-loaded LNPs to red blood cell membrane proteins, utilizing the natural spleen-homing characteristics of red blood cells to achieve targeted mRNA delivery for in vivo immune cell reprogramming and efficient generation of CAR-myeloid cells.
The results showed that mRNA–LNP–Ery achieved highly selective mRNA delivery to the spleen with minimal liver uptake and preferentially targeted splenic CD11b⁺ myeloid cells; delivery of HER2 or CD19 CAR mRNA generated functional CAR-myeloid cells in vivo, which acquired a pro-inflammatory, antigen-presenting phenotype, migrated to tumors, and mediated tumor clearance, accompanied by increased infiltration of effector T cells and NK cells.
In various tumor models(Including immunologically "cold" tumors)In China, one-tenth of the traditional LNP mRNA dose induced a stronger and more durable anti-tumor response. The anti-tumor efficacy disappeared in splenectomized mice and partially decreased in immunodeficient mice, indicating that the efficacy depends on the generation of splenic CAR-myeloid cells and their synergy with adaptive immunity.
More company pipelines such as CircleBio and JiaChen West Sea,See details: New breakthrough in non-viral delivery! Six Chinese companies make new progress in LNP delivery of in vivo CAR-T
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References:
1. Official information of each company
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