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China’s First mRNA-Based In Vivo CAR-T Candidate! Medicilon Supports Regenelead RGL-208 IND Approval

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November 3 — RGL-208 Injection, a dual-target in vivo CAR-T candidate independently developed by Regenelead, has received implied clinical trial approval from the NMPA. It is intended for the treatment of relapsed/refractory B-cell non-Hodgkin lymphoma. RGL-208 marks China’s first mRNA in vivo CAR-T product to enter clinical development, as well as Regenelead’s first in vivo CAR-T candidate advancing into the clinic.

As a partner of Regenelead, Medicilon provided pharmacokinetic and safety assessment studies for RGL-208, satisfying regulatory requirements for the NMPA, FDA and OECD, and enabling the candidate’s smooth transition into clinical testing.

Unmet Clinical Needs: Limitations of Current CAR-T Therapies Conventional CAR-T therapies involve complex manufacturing and lengthy lead times, creating major barriers to patient access.

Relapsed/refractory B-cell hematological malignancies are highly heterogeneous and prone to recurrence, with poor outcomes for patients after multiple lines of treatment, representing a substantial unmet medical need. While several approved CAR-T products have offered curative potential, these existing therapies rely on ex vivo personalized manufacturing. The cumbersome workflows, long production cycles and high costs, paired with relapse risks driven by antigen loss and CAR-T cell exhaustion in single-target designs, severely limit accessibility. Expanding access so that more patients can rapidly receive CAR-T treatment remains one of the core challenges in cell therapy.

Dual-Target, Off-the-Shelf In Vivo CAR-TGenerating In Vivo CAR-T cells to advance cell therapy toward off-the-shelf solutions

RGL-208 Injection is a dual-target in vivo CAR-T candidate discovered and developed by Regenelead. As China’s first mRNA in vivo CAR-T product cleared for clinical investigation, it opens a new route to address key pain points of traditional CAR-T therapies and improve access to cell therapy.

mRNA-LNP delivery platform: mRNA encoding the CAR construct is specifically delivered to patients’ T cells to generate functional in vivo CAR-T cells, which recognize and eliminate tumor cells.

Dual-target design to mitigate relapse: By targeting two antigens simultaneously, RGL-208 helps reduce tumor escape caused by the loss or downregulation of a single antigen..

Off-the-shelf format without individualized manufacturing: Patients can be treated by a single intravenous administration — no leukapheresis, no waiting for in vitro manufacturing, drastically cutting waiting time.

Lower barriers for manufacturing and access: The mRNA-LNP platform offers the potential for standardized, large-scale manufacturing, which could reduce production costs and extend cutting-edge cell therapy to a broader patient population.

The IND approval of RGL-208 represents a landmark breakthrough for Regenelead in in vivo CAR-T research, placing the company among China’s front-runners for clinical translation of in vivo CAR-T programs. It further demonstrates the innovative strength and translational capacity of Regenelead’s proprietary technology platforms.

Platform-Driven Preclinical Support Medicilon’s CGT platform powers preclinical development for cell and gene therapies

During RGL-208’s preclinical development, Medicilon deployed a suite of analytical platforms including flow cytometry, ELISA, PCR and LC-MS/MS to conduct systematic in vivo efficacy and toxicity evaluations. For the cynomolgus monkey toxicology program tailored to RGL-208, our team established immune-related response monitoring and emergency-response plans tailored to the product’s characteristics. In pharmacology studies using humanized immunodeficient mouse models, Medicilon precisely constructed the animal models and carefully controlled for model-related background lesions during data interpretation, delivering a scientifically rigorous and complete assessment of RGL-208’s efficacy and safety.

With deep expertise in cell and gene therapy, Medicilon has built a comprehensive CGT service platform covering leading immune cell modalities including CAR-T (in vivo CAR-T included), TCR-T, CAR-NK and TIL. Our service portfolio spans pharmacology and efficacy studies, pharmacokinetics, bioanalysis and safety evaluation. To date, we have supported nine cell therapy candidates in securing IND approvals.

Medicilon congratulates Regenelead on the IND clearance of RGL-208 Injection. We look forward to its steady clinical progression and hope this novel therapy will soon bring an easier, faster and more affordable cell treatment to patients. Moving forward, leveraging our mature one-stop preclinical platform and extensive global regulatory filing experience, Medicilon will continue empowering innovative drug developers to accelerate the journey from target discovery to IND.
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