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CAR-T Cell Therapy

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Education · Service Delivery · Technical Validation · Three-in-One

Chimeric Antigen Receptor T-cell Therapy--teaching patients' own immune cells to precisely hunt down tumors. This page serves three audiences: patients and public wanting to understand CAR-T, CAR-T teams seeking computational service partners, and investors and peers evaluating technical capabilities.

Patients & Public

Read "What is CAR-T", "Workflow", "Milestones", "Current Challenges" below--change your understanding of the therapy.

CAR-T Teams / Hospitals

Focus on "DiVo's Role", "5-Step Pipeline", "Verified Capabilities"--we have sample reports available.

Investors / Peers

Focus on "Differentiation", "Benchmarks", "Industry Market", "Glossary"--evaluate technical barriers.

To Patients and Families

DiVo Gen²AI's CAR-T computing service is a business that works in coordination with medical institutions and CAR-T treatment teams, not a service directly for individual users and patients. CAR-T cell therapy involves serious immune reaction risks (e.g., CRS, ICANS) and must be implemented by professional teams in qualified medical institutions. We provide dry-lab computational steps for target screening and Binder design. Please contact us through your treating physician.

What is CAR-T

CAR-T stands for Chimeric Antigen Receptor T-cell Therapy. Simply put: T cells (the immune system's "warriors") are extracted from the patient, equipped with an artificially designed "navigator" (CAR), and reinfused to precisely identify and kill tumor cells.

The fundamental difference from traditional chemotherapy and targeted drugs is: CAR-T uses living cell drugs--after reinfusion, CAR-T cells proliferate, patrol, and continuously kill tumors in vivo, theoretically achieving long-term remission from a single treatment. Patients have survived cancer-free for over 10 years after a single CAR-T treatment.

But CAR-T is not a panacea. As of 2026, globally approved CAR-T therapies almost exclusively target hematological tumors (lymphoma, leukemia, myeloma). Solid tumors (lung, liver, gastric cancers accounting for 90% of cancers) remain the biggest challenge--the core bottleneck is target selection.

6 Steps of CAR-T Therapy

From blood collection to reinfusion, a complete CAR-T treatment workflow

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1

Collection

Isolate T cells (a type of white blood cell, the immune system's "warriors") from patient blood

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2

Engineering

Use viral vectors to introduce CAR genes into T cells, expressing chimeric antigen receptors on their surface--like equipping warriors with "navigators"

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3

Expansion

Expand engineered CAR-T cells to hundreds of millions to billions in GMP facilities

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4

Conditioning

Patient receives lymphodepletion chemotherapy to make "living space" for CAR-T cells

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5

Infusion

Reinfuse CAR-T cells into the patient, where they begin seeking and attacking tumor cells expressing target antigens

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6

Monitoring

Closely monitor adverse reactions including CRS (Cytokine Release Syndrome) and ICANS (Immune effector Cell-Associated Neurotoxicity Syndrome)

The entire process takes about 2-4 weeks (mainly cell engineering and expansion time). Step 2 "Engineering"--deciding who CAR targets--is the entry point for DiVo Gen²AI's computational service.

CAR Structure

The chimeric antigen receptor consists of 5 functional domains--DiVo primarily acts on the first

1

scFv / Binder

Antigen Binding DomainDiVo

CAR's "eyes", recognizing target antigens on tumor surfaces. Traditionally uses scFv (single-chain variable fragment), new generation can use AI-designed protein Binders.

2

Hinge

Hinge

Flexible segment connecting the binding domain and transmembrane region, providing spatial flexibility.

3

Transmembrane

Transmembrane

Anchors CAR to the T cell membrane.

4

Costimulatory

Costimulatory Domain

Provides the second signal for T cell activation (CD28 or 4-1BB), determining CAR-T killing intensity and persistence.

5

CD3ζ

Signaling Domain

Provides the first signal for T cell activation, triggering the killing mechanism.

CAR-T Development Milestones

From the first case in 2012 to the AI+Binder era in 2025

2012

Emily Whitehead became the first child to receive CAR-T therapy, advanced ALL achieved complete remission

Cancer-free for 13 years

2017

Kymriah (Novartis) received FDA approval, world's first CAR-T therapy launched

B-ALL indication

2021

Yikaida (Fosun Kite) and Beinuoda (JW Therapeutics) received NMPA approval

China CAR-T year one

2022

Carvykti (Legend Biotech/J&J) received FDA approval, Chinese-origin CAR-T goes global

BCMA multiple myeloma

2024

Xie Qi/Cao Longxing Nature BME: computationally designed Binder replaces scFv, CAR-T efficacy significantly improved

AI+CAR-T milestone

2025

Science trilogy: de novo pMHC binder can be integrated into CAR structure

CAR-T targeting intracellular neoantigens

5 Major Challenges in CAR-T

Each challenge corresponds to a computational entry point--see what DiVo can do

1

Solid Tumor Target Scarcity

Hematological tumors have mature targets like CD19/BCMA, but solid tumors lack tumor-specific surface antigens--targets are also expressed in normal tissue, causing "off-target toxicity".

DiVo:双通道靶点发现
2

Antigen Escape

Tumor cells evade CAR-T recognition by downregulating target antigen expression. Single-target CAR-T is prone to escape, requiring dual/multi-target strategies.

DiVo:多靶点组合设计
3

scFv Limitations

Traditional scFv derived from existing antibody libraries, with limited affinity and stability optimization space, and may trigger anti-drug antibody (ADA) responses.

DiVo:de novo Binder 设计
4

Tumor Microenvironment Suppression

Immunosuppressive factors in the solid tumor microenvironment (TGF-β, IL-10, PD-L1) weaken CAR-T function.

DiVo:暂无直接能力
5

Manufacturing Complexity

Autologous CAR-T requires "one person, one product", with a 2-4 week preparation period during which some patients experience disease progression.

DiVo:通用型 CAR-T 是解决方向(非我们能力)

DiVo Gen²AI's Role

In the CAR-T workflow, we handle the dry-lab computational steps of "navigator design"

In the CAR-T workflow, "deciding who CAR targets" and "designing the navigator" are the steps most dependent on computational prediction--impossible to experimentally validate each candidate target, algorithms must precisely filter from sequencing data.

  • Target Discovery--dual-channel parallel: VCF neoantigen screening + RNA-seq surface antigen mining
  • de novo Binder Design--RFdiffusion + ProteinMPNN, replacing traditional scFv
  • Structure Validation--Protenix atomic-level 3D structure, confirming interaction credibility
  • mRNA Sequence Optimization--GEMORNA optimizing CAR construct mRNA sequences

We do not produce CAR-T cells, do not provide clinical diagnostic opinions, do not do cell culture/expansion processes. We deliver target recommendation lists + Binder sequence design proposals that can directly enter wet-lab synthesis and preclinical validation.

Three Key Differentiators

Capabilities that traditional CAR-T pipelines lack

2X

Dual-Channel Target Discovery

Traditional CAR-T target discovery relies on mutation annotation or experience. DiVo runs two channels simultaneously--VCF neoantigen screening (MHC affinity) + RNA-seq differential expression (tumor-specific membrane proteins), cross-validating to produce candidate targets.

AI

de novo Binder Design

Traditional CAR-T uses scFv antibody fragments as antigen binding domains, limited by existing antibody libraries. DiVo uses RFdiffusion + ProteinMPNN to design protein Binders from scratch, breaking through scFv affinity and stability bottlenecks--Xie Qi/Cao Longxing 2024 Nature BME validated this approach.

3D

pMHC 3D Structure Validation

Traditional pipelines stop at IC50 values. DiVo builds atomic-level pMHC 3D structures for each candidate target (pLDDT=95.4, ipTM=0.977), validating antigen-MHC interaction credibility at the structural level, reducing false positives.

Verifiable Engineering Foundation

MetricValueNote
MHC-I allele coverage65+IC50 min 10.1 nM
MHC-II allele coverage2513 DR + 5 DP + 7 DQ
pMHC structure pLDDT95.4Approaching X-ray crystallography precision
pMHC ipTM0.977Complex overall confidence
RNA-seq index253,181GENCODE v46 transcripts
TCR repertoireTRUST4 v1.1.9Clonotype diversity analysis
Binder design pipelineRFdiffusion + MPNNFrom backbone to sequence end-to-end
Structure validationProtenix + PXMeter400+ complexes validated at scale

Honest Boundaries

What we can and cannot do, clearly stated

What We Can Do

Neoantigen screening -> CAR target recommendation list
RNA-seq differential expression -> surface antigen mining
de novo Binder design + structure validation
TCR repertoire analysis (TRUST4)
Genomic risk stratification (PRS + TMB)
mRNA sequence optimization (CAR construct)

What We Don't Do

Do not directly provide diagnostic opinions to patients
Do not produce CAR-T cells or vaccine entities
Do not predict clinical efficacy/toxicity (lack clinical data)
Do not do CAR construct assembly (wet-lab team responsibility)
Do not do cell culture/expansion process optimization

Industry Market Reference

Compiled from public information · Not DiVo pricing · For reference only

Boundary Note: The following are market public reference prices for complete courses of CAR-T cell therapy, covering cell collection, CAR engineering, expansion, reinfusion, hospitalization, and adverse reaction management. DiVo Gen²AI handles the dry-lab computational steps (i.e., the 5-step pipeline on this page), and is not the producer or treatment provider of CAR-T cells.

China Marketed
·Yikaida/Beinuoda/Fokesu/Najiaolunsai/Xidajiaolunsai
·~1.2M RMB/dose
·Lymphoma/myeloma
Global Pipeline
·200+ clinical trials
·$300K-500K/course
·Solid tumors are the main battlefield

Solid tumor CAR-T is the global R&D main battlefield--whoever first solves target selection and off-target toxicity will capture the next decade's growth engine. The global CAR-T market is projected to exceed $50 billion by 2030.

Glossary

10 most common terms in CAR-T

Abbr.Full NameTranslationExplanation
CARChimeric Antigen ReceptorChimeric Antigen ReceptorArtificially designed receptor enabling T cells to recognize specific target antigens
scFvSingle-Chain Variable FragmentSingle-Chain Variable FragmentTraditional CAR antigen binding domain, derived from natural antibodies
CRSCytokine Release SyndromeCytokine Release SyndromeCAR-T activation releases large amounts of cytokines, causing fever, hypotension, potentially life-threatening
ICANSImmune effector Cell-Associated Neurotoxicity SyndromeImmune effector Cell-Associated Neurotoxicity SyndromeNeurotoxicity reaction from CAR-T therapy, presenting as confusion, seizures, etc.
NeoantigenNeoantigenNeoantigenAntigen peptides produced by tumor-specific mutations, not expressed in normal tissue
MHCMajor Histocompatibility ComplexMajor Histocompatibility ComplexThe "display board" on cell surfaces, presenting intracellular protein fragments to T cells
pMHCpeptide-MHC complexpeptide-MHC ComplexAntigen peptide complex presented by MHC molecules, the target of T cell recognition
BinderDe novo Protein BinderDe novo Protein BinderAI-designed proteins from scratch that can bind targets with high affinity, replacing traditional scFv
TMBTumor Mutational BurdenTumor Mutational BurdenNumber of mutations in the tumor genome, high TMB usually means more neoantigen candidates
ipTMinterface predicted TM-scoreinterface predicted TM-scoreProtein complex interface interaction confidence, >0.75 is high confidence