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Autologous CAR-T
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Product Candidate1
Technology
Target
Indication
Pre-clinical
Phase I
Phase II/III2
BLA/NDA

Zevor-cel (CT053)3

Zevor-cel (CT053)

fully-human BCMA CAR T for the treatment of Multiple Myeloma
Product Candidate:

Zevor-cel (CT053)

Technology:

Conventional

Target: BCMA
Indication: R/R MM

Zevorcabtagene autoleucel (Zevor-cel, R&D code: CT053) is a fully human, autologous BCMA CAR T-cell product for the treatment of R/R MM. Zevorcabtagene autoleucel was approved by the NMPA on February 23, 2024, for the treatment of adult patients with relapsed or refractory multiple myeloma who have previously progressed after at least 3 lines of therapy (at least one proteasome inhibitor and immunomodulator).

Clinical studies

Investigator-Initiated Trial

 

Phase I/II Clinical Trial (LUMMICAR STUDY 1)

  Phase 1b/2 Clinical Trial (LUMMICAR STUDY 2)

Designations

RMAT designation, FDA

for relapsed and/or refractory multiple myeloma (R/R MM)

Orphan Drug designation, FDA

for multiple myeloma (MM)

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Technology:

Conventional

Target:
BCMA
BCMA
Indication
Pre-clinical
Phase I
Phase II/III2
BLA/NDA
R/R MM (4L+)
LUMMICAR 1 (China)
On Market
R/R MM
LUMMICAR 2 (US, Canada)

Satri-cel (CT041)

Satri-cel (CT041)

Claudin18.2 CAR T for the treatment of Solid tumors
Product Candidate:

Satri-cel (CT041)

Technology:

Conventional

Target: Claudin18.2
Indication: G/GEJA, PC, etc.

CT041 is an autologous CAR T product candidate that targets Claudin18.2 (“CLDN18.2”), which is a stomach-specific isoform of CLDN18 and is highly expressed in gastric and pancreatic cancer cells.

Clinical studies

Investigator-initiated trials for solid tumors

 

Phase Ib clinical trial for advanced G/GEJA and PC and a confirmatory Phase II clinical trial for advanced G/GEJA

 

Phase Ib clinical trial for PC adjuvant therapy

 

Investigator-initiated trial for G/GEJA adjuvant therapy

Phase 1b/2 clinical trial for advanced gastric or pancreatic adenocarcinoma

 

Designations

RMAT designation, FDA

for advanced gastric /gastroesophageal junction adenocarcinoma (G/GEJA) with Claudin18.2-positive tumor

Orphan Drug designation, FDA

for gastric /gastroesophageal junction cancer(G/GEJA)

Breakthrough Therapy designation, NMPA

for advanced gastric/gastroesophageal junction cancer (G/GEJC) in patients who have failed at least two prior lines of therapy.

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Technology:

Conventional

Target:
Claudin18.2
Claudin18.2
Indication
Pre-clinical
Phase I
Phase II/III2
BLA/NDA
G/GEJA (3L+)
ST-01 (China)
GC/PC
ST-02 (US, Canada)
PC (adjuvant)
ST-05 (China)
G/GEJA, PC, etc.
IIT (China)
G/GEJA (adjuvant)
IIT (China)

CT071

CT071

GPRC5D CAR T for the treatment of Multiple Myeloma and Plasma Cell Leukemia
Product Candidate:

CT071

Technology:

CARcelerate®

Target: GPRC5D
Indication: R/R MM, R/R PCL, NDMM

CT071 is a CAR T-cell therapy candidate developed utilizing our proprietary CARcelerate® platform, targeting GPRC5D. CARcelerate® platform can shorten the manufacturing time for the CAR T cells to about 30 hours.

Clinical studies

Investigator-initiated trial for R/R MM or R/R PCL

Investigator-initiated trial for newly diagnosed multiple myeloma (NDMM)

Phase 1 clinical trial for R/R MM or R/R pPCL

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Technology:

CARcelerate®

Target:
GPRC5D
GPRC5D
Indication
Pre-clinical
Phase I
Phase II/III2
BLA/NDA
R/R MM,R/R pPCL
(US)
R/R MM,R/R PCL
IIT(China)
NDMM
IIT(China)

CT011

CT011

GPC3 CAR T for the treatment of Hepatocellular Carcinoma
Product Candidate:

CT011

Technology:

Conventional

Target: GPC3
Indication: HCC

CT011 is an autologous CAR T product candidate that targets glypican-3 (GPC3), which is highly expressed in HCC and is suggested to be a prognostic marker for the disease.

Clinical studies

Investigator-initiated trials

 

Phase I trial for GPC3-positive solid tumor (China’s first IND clearance for CAR T-cell therapy against solid tumors)

 

Phase I trial for GPC3-positive stage IIIa hepatocellular carcinoma at high risk of recurrence after surgical resection

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Technology:

Conventional

Target:
GPC3
GPC3
Indication
Pre-clinical
Phase I
Phase II/III2
BLA/NDA
HCC (adjuvant)
(China)
Allogeneic CAR-T
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Product Candidate1
Technology
Target
Indication
Pre-clinical
Phase I
Phase II/III2
BLA/NDA

CT0590

CT0590

Allogeneic BCMA CAR-T for the treatment of R/R MM
Product Candidate:

CT0590

Technology:

THANK-uCAR®

Target: BCMA
Indication: R/R MM, R/R PCL

CT0590 is an allogeneic CAR T-cell therapy developed utilizing our proprietary THANK-uCAR® platform, targeting BCMA and NKG2A (a membrane protein expressed in NK and T cells), and a triple knockout for TRAC/B2M/NKG2A which allows it to avoid graft-versus-host disease (GvHD) and host-versus-graft reaction (HvGR), making it fratricide-resistant while enhancing its immune function.

Clinical studies

Investigator-initiated trial for R/R MM

More+
Technology:

THANK-uCAR®

Target:
BCMA
BCMA
Indication
Pre-clinical
Phase I
Phase II/III2
BLA/NDA
R/R MM, R/R PCL
IIT(China)

CT0596

CT0596

THANK-u Plus™
Product Candidate:

CT0596

Technology:

THANK-u Plus™

Target: BCMA
Indication: R/R MM, R/R PCL

CT0596 is an allogeneic BCMA-targeted CAR-T therapy developed using CARsgen’s proprietary THANK-u Plus™ platform. CT0596 demonstrated preliminary favorable tolerability and encouraging efficacy signals and CAR-T expansion across all predefined dose levels.

Clinical studies

Investigator-initiated trial for R/R MM and R/R PCL (Shanghai Changzheng Hospital)

 

Investigator-initiated trial for R/R MM and R/R PCL (The First Affiliated Hospital of Soochow University)

 

Investigator-initiated trial for PCL (Institute of Hematology & Blood Diseases Hospital)

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Technology:

THANK-u Plus™

Target:
BCMA
BCMA
Indication
Pre-clinical
Phase I
Phase II/III2
BLA/NDA
R/R MM, R/R PCL
IIT (China)

KJ-C2219
Product Candidate:
Technology:

THANK-uCAR®

Target: CD19/CD20
Indication:
More+
Technology:

THANK-uCAR®

Target:
CD19/CD20
CD19/CD20
Indication
Pre-clinical
Phase I
Phase II/III2
BLA/NDA
B-cell malignancies
IIT (China)
SLE, SSc
IIT (China)

KJ-C2320
Product Candidate:
Technology:

THANK-uCAR®

Target: CD38
Indication:
More+
Technology:

THANK-uCAR®

Target:
CD38
CD38
Indication
Pre-clinical
Phase I
Phase II/III2
BLA/NDA
AML
IIT (China)

KJ-C2114
Product Candidate:
Technology:

THANK-uCAR®

Target: Undisclosed
Indication:
More+
Technology:

THANK-uCAR®

Target:
Undisclosed
Undisclosed
Indication
Pre-clinical
Phase I
Phase II/III2
BLA/NDA
Solid tumors

KJ-C2526
Product Candidate:
Technology:

THANK-uCAR®

Target: NKG2DL
Indication:
More+
Technology:

THANK-uCAR®

Target:
NKG2DL
NKG2DL
Indication
Pre-clinical
Phase I
Phase II/III2
BLA/NDA
AML, other malignancies, senescence
for hematologic malignancies
for solid tumors
for autoimmune diseases

R/R MM: relapsed/refractory multiple myeloma; G/GEJA: gastric /gastroesophageal junction adenocarcinoma;  GC: gastric cancer;  PC: pancreatic cancer; HCC: hepatocellular carcinoma; R/R pPCL: relapsed/refractory primary plasma cell leukemia; NDMM: newly diagnosed multiple myeloma; SLE: systemic lupus erythematosus; SSc: systemic sclerosis; AML: acute myeloid leukemia

1 All product candidates are self-developed with global rights

2 Phase II trials of some indications are pivotal studies

3 Core Product Candidate. Commercial rights in mainland China have been granted to Huadong Medicine (SZ: 000963). Rights in the South Korean market have been licensed out to HK Inno.N (KOSDAQ: 195940)