Zhenyu Dai, M.D., Ph.D.

Zhenyu Dai, M.D., Ph.D.

Postdoctoral Scholar | Translational Immunologist

Stanford University School of Medicine

✉ [email protected]

⚲ Stanford, CA

Google Scholar

About

Translational immunologist with 9+ years driving CAR- and antibody-based programs from discovery to clinical trials. Proven track record advancing 5 products to clinical stage with 2 FDA IND approvals, 2 FDA Orphan Drug Designations, and generating >$162M in licensing value.

Published 11 peer-reviewed papers (6 first-author) in top-tier journals including Signal Transduction and Targeted Therapy (IF: 52.7), Journal of Clinical Investigation (IF: 13.6), and Molecular Therapy (IF: 12). Expert in off-the-shelf cell therapy development, antibody discovery via phage display, and IND-enabling preclinical studies.

Key Achievements

5
Clinical Translations
Products advanced to clinical trials
2+1
IND Approvals
FDA INDs + NMPA IND
$162M+
Commercial Value
Licensing deals generated
11
Publications
Peer-reviewed papers (6 first-author)
11
Patents
Granted/filed as co-inventor

Research Experience

Postdoctoral Scholar

2022 - Present

Stanford University School of Medicine, Stanford, CA

Off-the-Shelf CAR-T Development

  • Developed feeder-free expansion protocol for CD19/CD7 CAR gamma-delta T cells maintaining CM-like phenotype
  • Established combination immunotherapy framework integrating allogeneic SCT with CAR gamma-delta T treatments
  • Engineered cytokine-armored CD19/CD7 CAR constructs with enhanced proliferation and antitumor activity
  • Optimized dual knockout process enabling efficient CRISPR-based CD5/CD7 gene disruption for gamma-delta T cells

Postdoctoral Fellow

2021 - 2022

City of Hope - Beckman Research Institute, Duarte, CA

CAR-iNKT/NK Platform Development

  • Engineered IL-15-armored iNKT cells with PSCA-targeting CAR for pancreatic cancer (J Clin Invest 2025, IF: 13.6)
  • Generated novel IP on IL-15-armored CAR-iNKT platform
  • Built end-to-end CAR-NK manufacturing pipeline achieving 75% transduction efficiency and 500-fold expansion
  • Screened CAR constructs targeting CD33, FLT3, CLL-1, and PSCA for off-the-shelf applications

Ph.D. Researcher & Project Leader

2016 - 2021

Tongji Hospital, HUST & IASO Biotherapeutics, Wuhan, China

CAR-T Clinical Translation

Clinical Translation Success (5 Products):

CD5-Targeting Biepitopic CAR-T

Lead Developer

First fully human CD5 CAR achieving 100% CR/CRi in Phase 1 T-ALL trial (Nature Medicine 2025)

CD19 Antibody Discovery

Lead Developer

Licensed to Cabaletta Bio for $162M (resecabtagene autoleucel/CABA-201). FDA Orphan Drug Designation for systemic sclerosis.

CD19/CD22 Bispecific CAR-T

Co-Inventor

CT120 - World's first fully human dual-target CAR. FDA Orphan Drug Designation.

GPRC5D CAR-T

Co-Developer

~94% ORR with ~18.2-month median PFS in multiple myeloma (Blood 2025). NMPA IND Approval.

IASO-782 Anti-CD19 mAb

Co-Developer

FDA IND Approval. Phase Ia trials for ITP and AIHA.

Publications

First-Author Publications

IF: 52.7 84 citations

T cells expressing CD5/CD7 bispecific chimeric antigen receptors with fully human heavy-chain-only domains mitigate tumor antigen escape

Dai Z*, Mu W*, Zhao Y, Cheng J, Lin H, Ouyang K, Jia X, Liu J, Wei Q, Wang M, Liu C.

Signal Transduction and Targeted Therapy. 2022 Mar 25;7(1):85.

IF: 13.6 3 citations

Off-the-shelf invariant NKT cells expressing anti-PSCA CAR and IL-15 promote pancreatic cancer regression in mice

Dai Z*, Zhu Z*, Li Z*, Tian L*, Teng KY, Chen H, Wang LS, Zhang J, Melstrom L, Caligiuri MA, Yu J.

Journal of Clinical Investigation. 2025 Apr 15;135(8).

IF: 12 67 citations

The rational development of CD5-targeting biepitopic CARs with fully human heavy-chain-only antigen recognition domains

Dai Z*, Mu W*, Zhao Y, Jia X, Liu J, Wei Q, Tan T, Zhou J.

Molecular Therapy. 2021 Sep 1;29(9):2707-2722.

IF: 6.1 3 citations

Targeting intracellular LMP2 with costimulatory signal-armed antibody-like TCR T cells

Cheng J*, Hu X*, Dai Z*, Zeng Y, Jin J, Mu W, Wei Q, Jia X, Liu J, Xie M, Luo Q.

JCI Insight. 2025 May 22;10(10):e178572.

IF: 4.0 8 citations

Development and functional characterization of novel fully human anti-CD19 chimeric antigen receptors for T-cell therapy

Dai Z, Hu X, Jia X, Liu J, Yang Y, Niu P, Hu G, Tan T, Zhou J.

Journal of Cellular Physiology. 2021 Aug;236(8):5832-5847.

IF: 3.3

Species authentication of common meat based on PCR analysis of the mitochondrial COI gene

Dai Z*, Qiao J*, Yang S*, Hu S, Zuo J, Zhu W, Huang C.

Applied Biochemistry and Biotechnology. 2015 Jul;176:1770-80.

Co-Author Publications

IF: 11.6 25 citations

Anti-CD5 CAR-T cells with a tEGFR safety switch exhibit potent toxicity control

Lin H, Cheng J, Zhu L, Zeng Y, Dai Z, Zhang Y, Zhu X, Mu W.

Blood Cancer Journal. 2024 Jun 18;14(1):98.

IF: 5.1 31 citations

Preclinical development and evaluation of nanobody-based CD70-specific CAR T cells for the treatment of acute myeloid leukemia

Cheng J, Ge T, Zhu X, Wang J, Zeng Y, Mu W, Cai H, Dai Z, Jin J, Yang Y, Hu G, Mao X, Zhou J, Zhu L, Huang L.

Cancer Immunology, Immunotherapy. 2023 Jul;72(7):2331-46.

Epigenetic enhancement of adoptive T cell immunotherapy

Dai Z, Smith M.

Cancer Cell. 2025;43(3):340-342.

10 citations

B7H6 serves as a negative prognostic marker and an immune modulator in human pancreatic cancer

Zhu Z, Teng KY, Zhou J, Xu Y, Zhang L, Zhao H, Zhang X, Tian L, Li Z, Dai Z, et al.

Frontiers in Oncology. 2022;12:814312.

5 citations

Case report: Differential diagnosis of highly amplified anti-CD5 CAR T cells and relapsed lymphoma cells

Mu W, Zhang M, Hu G, Han Y, Mao X, Chen C, Shen K, Dai Z, Zhu X, et al.

Frontiers in Immunology. 2023;14:1280007.

23 citations

Clinical and immunological features of platelet transfusion refractoriness in young patients with de novo acute myeloid leukemia

Hu X, Cai H, Zheng L, Luo Y, Zhou J, Hui Y, Dai Z, Lin H, Li D, Xiao Y, et al.

Cancer Medicine. 2020;9(14):4941-4948.

Patent Portfolio

11 patents granted/filed as co-inventor, with 5 applied for clinical development

Patent Title Status Clinical Stage Impact
CD19 Antibody and CD19 CAR (WO/2020/233589) Filed 5 FDA trials >$162M
CD5 Tandem CAR (WO/2022/152186) Filed Phase 1 100% CR/CRi
CD5 Antibody and CD5 CAR (WO/2022/089644) Filed Basis of CD5 Tandem CAR -
CD19/CD22 Bispecific (WO/2022/002154) Filed Phase 1/2 (CT120) FDA ODD
GPRC5D CAR (WO/2023/173272) Filed NMPA IND, Phase 1 ~94% ORR
CD5 and CD7 CAR (WO/2023/011651) Filed Preclinical First-in-class
Anti-BCMA CAR Antibody (CN112062851) Granted Clinically deployed QC for FUCASO
PSCA-CAR iNKT + IL-15 (US 63/610,651) Filed Preclinical Platform
LMP2 TCR-like CAR T (CN110878126B) Granted Preclinical Platform
CD70 CAR (US20230399412A1) Filed Preclinical Multi-tumor

Education

Ph.D., Internal Medicine (Hematology & Immunotherapy)
Tongji Medical College, Huazhong University of Science and Technology
2016 - 2021 GPA: 3.81/4.0

Licensed Medical Practitioner (China)