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CEA-targeted CAR-T cells

Phase 1

Colorectal Cancer | Monoclonal antibody | Oncology |Precision BioSciences, Inc.|Last Updated: Sep 21, 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
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment30
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06043466A Clinical Trial Targeting CEA Chimeric Antigen Receptor T (CAR-T) for CEA Positive Advanced Malignant Solid TumorsPHASE1 RECRUITING 30Aug 11, 2023Dec 31, 2027Sep 21, 20232 China
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Study Endpoints
Primary Endpoints
To determine the dose range and DLT of C-13-60 cells for CEA positive advanced malignant solid tumors [Safety and Tolerability]
1 month

The incidence of adverse events (TEAE) after treatment; Incidence of treatment-related adverse events; Adverse evens of Special Interest (AESI);

To obtain the maximum tolerable dose of C-13-60 cells [Safety and Tolerability]
1month

Incidence and number of dose-limiting toxicity (DLT) cases,Dose-limiting toxicity after CAR-T cell infusion

Secondary Endpoints
Disease control rate (DCR) within 3 months after infusion of C-13-60 cell preparation[Effectiveness]
3 months
Area under the curve (AUCS) of C-13-60 cell [Cell dynamics]
3 months
Maximum concentration (CMAX) of C-13-60 cell [Cell dynamics]
3 months
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Intravenous of CEA-targeted CAR-TEXPERIMENTALInfusion of CEA-targeted CAR-T cells by dose of 2-10x10\^6 cells/kg
Interventions
NameTypeDescription
CEA-targeted CAR-T cellsBIOLOGICALAdministration method: intravenous infusion; Subjects will receive conditioning therapy by Fludarabine and Cyclophosphamide before cell infusion.
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: 1. Age ≥18 years old, male or female; 2. Patients with advanced malignant solid tumors confirmed by histology or pathology, including colorectal cancer, esophageal cancer, gastric cancer, pancreatic cancer, non-small cell lung cancer, breast cancer, and cholangiocarcinoma; 3. Pr...

Countries:China
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Competitive Landscape -Colorectal Cancer 263 trials
CompanyTickerTrialsLead PhaseDrugs
AbbVie, Inc.ABBV8PHASE3Telisotuzumab Adizutecan, Telisotuzumab adizutecan, Bevacizumab, Trifluridine/Tipiracil, ABBV-400
Bristol-Myers Squibb CompanyBMY7PHASE3Ipilimumab, Oxaliplatin, Leucovorin, Fluorouracil, Irinotecan
Merck & Co., Inc.MRK6PHASE3Pembrolizumab, Oxaliplatin, Leucovorin, 5-fluorouracil, Irinotecan
Johnson & JohnsonJNJ5PHASE3Amivantamab, Cetuximab, 5-fluorouracil, Leucovorin calcium/Levoleucovorin, Oxaliplatin
Pfizer Inc.PFE12PHASE3PF-08634404, Bevacizumab, Chemotherapy, tucatinib, trastuzumab
GSK plc Sponsored ADRGSK6PHASE3Dostarlimab, CAPEOX, FOLFOX, GSK4418959, PD-1 inhibitor
Exelixis, Inc.EXEL5PHASE3XL092, Atezolizumab, Regorafenib, cabozantinib, atezolizumab
Summit Therapeutics IncSMMT3PHASE3Drug: Ivonescimab, Drug: Bevacizumab, AK112, AK117, Oxaliplatin
Natera, Inc.NTRA4PHASE3Capecitabine, Oxaliplatin, Folfirinox, FOLFOX regimen
Agenus Inc.AGEN4PHASE3Balstilimab, Botensilimab, CR6086, AGEN2034
Incyte CorporationINCY2PHASE3INCA33890, Bevacizumab, FOLFOX, Ruxolitinib, Capecitabine
Amgen Inc.AMGN1PHASE3FOLFIRI Regimen, Sotorasib, Panitumumab, Bevacizumab-awwb
Eli Lilly and CompanyLLY8PHASE2LY2157299, Capecitabine, Fluorouracil, LY4066434., Cetuximab
AstraZeneca PLCAZN8PHASE2Datopotamab deruxtecan, Capecitabine, 5-Fluorouracil, Volrustomig, Carboplatin
Takeda Pharmaceutical Co. Ltd. Sponsored ADRTAK5PHASE2fruquintinib, FOLFIRI, oxaliplatin , levofolinate calcium , 5-FU, panitumumab, mFOLFOX6 + panitumumab combination therapy
Novartis AG Sponsored ADRNVS7PHASE2Dabrafenib, Trametinib, JDQ443, TNO155, tislelizumab
BioNTech SE Sponsored ADRBNTX3PHASE2RO7198457, PM8002, Chemotherapy Regimen 1, BNT314, BNT327
Regeneron Pharmaceuticals, Inc.REGN2PHASE2Cemiplimab + Fianlimab, VV1, Cemiplimab
Revolution Medicines, Inc.RVMD7PHASE1RMC-6291, Elironrasib, Daraxonrasib, RMC-9805, RMC-6236
Veracyte, Inc.VCYT1PHASE3Tislelizumab
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Recent Changes (Last 90 Days)
LOWMay 24, 2026NCT06043466studyFirstPostDate: changed