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Targeted CEA CAR-T

Phase 1

Advanced Lung Cancer | Monoclonal antibody | Oncology |Precision BioSciences, Inc.|Last Updated: Jun 4, 2025

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 Trials4
Total Enrollment228
FDA Designations
No designations recorded
Clinical Trials (4)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06992583Targeted Anti-CEA CAR-T Immunotherapy for Advanced Lung CancerPHASE1 RECRUITING 60May 8, 2025Apr 30, 2028May 28, 20251 China
NCT06945523Clinical Study on Chimeric Antigen Receptor T Lymphocyte (CAR-T) Targeting CEA for the Treatment of CEA - Positive Advanced Lung CancerPHASE1 RECRUITING 60Apr 28, 2025Apr 30, 2028Jun 4, 20251 China
NCT06903117Anti-CEA CAR-T for Advanced CEA-Positive Lung CarcinomaPHASE1 RECRUITING 60Mar 24, 2025Mar 31, 2028Apr 3, 20251 China
NCT06768151A Clinical Trial of CEA Targeting CAR-T for CEA Positive Advanced Lung CancerPHASE1 RECRUITING 48Dec 12, 2024Dec 31, 2027Jan 10, 20251 China
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Study Endpoints
Primary Endpoints
To evaluate the safety and tolerability of CAR T cell preparations in the treatment of CEA positive advanced lung cancer【safety】
28days

Adverse events and their proportion during the trial (assessed against the Common Terminology Standard for Adverse Events Version 5.0 (CTCAE 5.0) and ASTCT standards)

Secondary Endpoints
To evaluate the disease control rate of CAR-T cell preparations in CEA positive advanced lung cancer【efficacy】
3months
To evaluate the remission rate of CAR-T cell preparations in CEA positive advanced lung cancer【efficacy】
3months
To evaluate the overall survival of CAR-T cell preparations in CEA-positive advanced lung cancer【efficacy】
2years
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Targeted CEA CAR-T intravenous infusion groupEXPERIMENTAL -
Targeting CEA CAR-T pleural infusion groupEXPERIMENTAL -
Targeted CEA CAR-T intravenous infusionEXPERIMENTAL -
Targeting CEA CAR-T intraperitoneal infusion groupEXPERIMENTAL -
Interventions
NameTypeDescription
Targeted CEA CAR-TBIOLOGICALSubjects meeting the transfusion criteria will receive pre-treatment, which is as follows: fludarabine 25mg/m2/d×3day and cyclophosphamide 300mg/m2/d×3day, and intravenous CEA CAR-T therapy after 1-2 days of rest
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: \- Participants must meet all of the following criteria to be eligible for enrollment: 1. Age ≥18 years, regardless of gender. 2. Histologically or cytologically confirmed advanced, metastatic, or recurrent lung cancer, including both non-small cell lung cancer (NSCLC) and sma...

Countries:China
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Competitive Landscape -Lung Cancer 290 trials
CompanyTickerTrialsLead PhaseDrugs
Merck & Co., Inc.MRK10PHASE3Pembrolizumab, Olaparib, Etoposide /m^2, Pembrolizumab/Vibostolimab Co-Formulation, Etoposide
Gilead Sciences, Inc.GILD5PHASE3Sacituzumab Govitecan, Topotecan, Amrubicin, Lurbinectedin, Domvanalimab
Amgen Inc.AMGN14PHASE3Tarlatamab, Durvalumab, ABP 234, Pembrolizumab, Lurbinectedin
AstraZeneca PLCAZN32PHASE3Durvalumab, Tremelimumab, Volrustomig, Pembrolizumab, Carboplatin
BioNTech SE Sponsored ADRBNTX6PHASE3Pumitamig, Atezolizumab, Etoposide, Carboplatin, PM8002
Bristol-Myers Squibb CompanyBMY15PHASE3MRTX849, Docetaxel, BMS-986489, Atezolizumab, Carboplatin
Pfizer Inc.PFE13PHASE3PF-08634404, Pembrolizumab, Chemotherapy Regimen 1, PF-07220060, Letrozole
AbbVie, Inc.ABBV4PHASE3ABBV-706, Topotecan, Lurbinectedin, Amrubicin, Telisotuzumab Adizutecan
ArriVent BioPharma, Inc.AVBP6PHASE3furmonertinib , daily, platinum-based chemotherapy, Firmonertinib, JAB-21822, Tislelizumab
Eli Lilly and CompanyLLY3PHASE3Ramucirumab, Erlotinib, Gefitinib, Osimertinib, LY4175408
Jazz Pharmaceuticals Public Limited CompanyJAZZ3PHASE3Atezolizumab, Lurbinectedin, Carboplatin, Etoposide, Durvalumab
Summit Therapeutics IncSMMT1PHASE3AK112
Revolution Medicines, Inc.RVMD2PHASE3daraxonrasib, docetaxel, RMC-6291, RMC-6236, Pembrolizumab
Incyte CorporationINCY3PHASE3Retifanlimab, Pemetrexed, Cisplatin, Carboplatin, Paclitaxel
Takeda Pharmaceutical Co. Ltd. Sponsored ADRTAK1PHASE3TAK-788, Pemetrexed, Cisplatin, Carboplatin
Regeneron Pharmaceuticals, Inc.REGN5PHASE2BNT116, Cemiplimab, Fianlimab, Pemetrexed, Paclitaxel
ImmunityBio IncIBRX3PHASE3Drug: Nogapendekin alfa inbakicept, Pembrolizumab, Cisplatin or Carboplatin, Nab-paclitaxel OR Pemetrexed, Nab-paclitaxel OR Paclitaxel OR Docetaxel
Immutep Ltd Sponsored ADRIMMP2PHASE3eftilagimod alfa, carboplatin plus paclitaxel, cisplatin or carboplatin + pemetrexed, pembrolizumab, IMP321
GSK plc Sponsored ADRGSK1PHASE3Ris-Rez, Topotecan
Zai Lab Ltd. Sponsored ADRZLAB2PHASE3ZL-1310, Atezolizumab, Carboplatin
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Recent Changes (Last 90 Days)
LOWMay 24, 2026NCT06903117studyFirstPostDate: changed
LOWMay 24, 2026NCT06992583studyFirstPostDate: changed
LOWMay 24, 2026NCT06945523studyFirstPostDate: changed
LOWMay 24, 2026NCT06768151studyFirstPostDate: changed