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CEA CAR-T cells

Phase 1

Gastric Cancer | Monoclonal antibody | Oncology |Precision BioSciences, Inc.|Last Updated: Nov 8, 2023

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
CONTROLLEDBiomarker
Total Trials1
Total Enrollment36
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06010862Clinical Study of CEA-targeted CAR-T Therapy for CEA-positive Advanced/Metastatic Malignant Solid TumorsPHASE1 RECRUITING 36Sep 30, 2023Sep 30, 2026Nov 8, 20231 China
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Study Endpoints
Primary Endpoints
Incidence of Adverse events after CEA CAR-T cells infusion [Safety and Tolerability]
28 days

Therapy-related adverse events were recorded and assessed according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, Version 5.0)

Obtain the maximum tolerated dose of CEA CAR-T cells[Safety and Tolerability]
28 days

Dose-limiting toxicity after cell infusion

Secondary Endpoints
Disease control rate of CAR-T cell preparations in CEA positive advanced malignancies [Effectiveness]
3 months
Objective response rate (ORR) of CEA CAR-T treatment in patients with CD70-positive advanced malignancies[Effectiveness]
3 months
Duration of Response (DOR) of CEA CAR-T treatment in patients with CEA-positive advanced malignancies[Effectiveness]
3 months
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Intravenous of CEA-targeted CAR-TEXPERIMENTALInfusion of CEA-targeted CAR-T cells by dose of 1-10x106 cells/kg
intraperitoneal injection of CEA-targeted CAR-TEXPERIMENTALInfusion of CEA-targeted CAR-T cells by dose of 1-10x106 cells/kg
Interventions
NameTypeDescription
CEA CAR-T cellsBIOLOGICALAfter lymphodepletion with Fludarabine and Cyclophosphamide,CAR T cells were transfused intravenically
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: 1. Age ≥18 years old, male or female; 2. Advanced, metastatic or recurrent malignant tumors diagnosed by histology or pathology, mainly colorectal cancer, esophageal cancer, gastric cancer, and pancreatic cancer; 3. After receiving at least second-line standard treatment failure...

Countries:China
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Competitive Landscape -Gastric Cancer 118 trials
CompanyTickerTrialsLead PhaseDrugs
AstraZeneca PLCAZN16PHASE3AZD0901, Ramucirumab+ paclitaxel, Paclitaxel, Docetaxel, Irinotecan
BeOne Medicines Ltd. Sponsored ADRONC4PHASE3Tislelizumab, Cisplatin, Leucovorin, 5-fluorouracil, Oxaliplatin
Jazz Pharmaceuticals Public Limited CompanyJAZZ3PHASE3Zanidatamab, Tislelizumab, Trastuzumab, Capecitabine, Oxaliplatin
Merck & Co., Inc.MRK1PHASE3pembrolizumab, cisplatin, 5-FU, leucovorin, levoleucovorin
Amgen Inc.AMGN2PHASE3Bemarituzumab, Nivolumab, Chemotherapy, CAPOX, SOX
Arcus Biosciences, Inc.RCUS2PHASE3Domvanalimab, Zimberelimab, Capecitabine, Fluorouracil, Leucovorin
Bristol-Myers Squibb CompanyBMY7PHASE2Pumitamig, Folfox, Capox, Nivolumab, BMS-986340
Pfizer Inc.PFE7PHASE2tucatinib, trastuzumab, oxaliplatin, leucovorin, fluorouracil
Agenus Inc.AGEN2PHASE3Balstilimab, Botensilimab, Folfox Protocol, XELOX, Nivolumab
AbbVie, Inc.ABBV2PHASE2Telisotuzumab Adizutecan, Budigalimab, Fluorouracil, Leucovorin, Oxaliplatin
Eli Lilly and CompanyLLY2PHASE2Ramucirumab, Paclitaxel, LY4337713
Compass Therapeutics, Inc.CMPX1PHASE2CTX-009, Paclitaxel
ALX Oncology Holdings, Inc.ALXO1PHASE2Evorpacept, Trastuzumab, Ramucirumab, Paclitaxel
GE Healthcare Technologies Inc.GEHC1PHASE2GEH300079 Positron-Emission Tomography /Computed Tomography
ImmunityBio IncIBRX1PHASE2N-803 + Pembrolizumab
Apollomics Inc. Class AAPLM1PHASE2APL-101
Exelixis, Inc.EXEL2PHASE1cabozantinib, atezolizumab, Cabozantinib, Durvalumab, Tremelimumab
Inhibrx Biosciences, Inc.INBX1PHASE1INBRX-106 - Hexavalent OX40 agonist antibody, pembrolizumab, Carboplatin AUC-5, Pemetrexed /m2, Cisplatin /m2
Tango Therapeutics, Inc.TNGX2PHASE2Trifluridine/Tipiracil, Oxaliplatin, FOLFOX regimen, Nivolumab, S095029
I-Mab Biopharma US LimitedIMAB2PHASE2Givastomig, Nivolumab, 5Fluorouracil, Leucovorin, Oxaliplatin
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Recent Changes (Last 90 Days)
LOWMay 24, 2026NCT06010862studyFirstPostDate: changed