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WT1-sensitized T cells

Phase 1

Leukemia | Monoclonal antibody | Oncology |Atara Biotherapeutics, Inc.|Last Updated: Mar 2, 2021

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 Enrollment22
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00620633Dose Escalation Trial of WT1-Sensitized T Cells for Residual or Relapsed Leukemia After Allogeneic Hematopoietic Progenitor Cell TransplantationPHASE1 COMPLETED 22Feb 8, 2008Feb 26, 2021Mar 2, 20211 United States
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Study Endpoints
Primary Endpoints
assess toxicity of in vitro expanded allogeneic WT1 peptide-specific T-cells derived from transplant donor,when given to patients with leukemia or other WT1+ hematologic malignancy having relapsed after transplant or persistent minimal residual disease
conclusion of the study
Secondary Endpoints
to assess the effects of the adoptively transferred T cells on the progression of disease
conclusion of the study
to quantitate the number of WT1 peptide-specific T cells in the blood at defined intervals post infusion in order to determine their survival and proliferation in the host.
conclusion of the study
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
1EXPERIMENTALPatients with leukemia or myelodysplastic syndrome (MDS) who, following an HLA-matched allogeneic hematopoietic cell transplant, have relapsed with leukemia as demonstrated morphologically on peripheral blood smear or bone marrow aspirate
Interventions
NameTypeDescription
WT1-sensitized T cellsBIOLOGICALEligible patients who consent to enter this trial and for whom WT1 sensitized T cells have been generated in vitro, will receive a single dose of allogeneic WT1-sensitized T cells by bolus intravenous infusion. In this phase I trial, 6 dose levels of T cells will be evaluated, in sequential groups of 3 patients. Dose Escalation will be based on the incidence and severity of toxicities.
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Eligibility Criteria
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Prior to receiving treatment, some patients may undergo diagnostic and/or other testing of their WT1 malignancies to determine if their disease is likely to respond to treatment with WT1 specific T cells. Alternatively, blood samples may be required for research tests to ascer...

Countries:United States
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Competitive Landscape -Leukemia 332 trials
CompanyTickerTrialsLead PhaseDrugs
Amgen Inc.AMGN8PHASE3Blinatumomab, Low-intensity chemotherapy regimen, HyperCVAD, Omitted Doxorubicin, Omitted Vincristine+Dexamethasone pulses
Eli Lilly and CompanyLLY10PHASE3Pirtobrutinib, Idelalisib, Bendamustine, Rituximab, Venetoclax
AstraZeneca PLCAZN20PHASE3Acalabrutinib, Rituximab, Chlorambucil, Venetoclax, Obinutuzumab
Merck & Co., Inc.MRK7PHASE3Nemtabrutinib, Fludarabine, Cyclophosphamide, Bendamustine, Rituximab
BeOne Medicines Ltd. Sponsored ADRONC14PHASE3Sonrotoclax, Zanubrutinib, Venetoclax, Obinutuzumab, Bendamustine
AbbVie, Inc.ABBV24PHASE3Venetoclax, Acalabrutinib, Obinutuzumab, Fludarabine, Cytarabine
Novartis AG Sponsored ADRNVS21PHASE3Imatinib, Nilotinib, Bosutinib, Dasatinib, Asciminib
Johnson & JohnsonJNJ12PHASE3Ibrutinib, Venetoclax, Chlorambucil, Obinutuzumab, Bleximenib
Nurix Therapeutics, Inc.NRIX5PHASE3NX-5948, Pirtobrutinib, venetoclax, rituximab, obinutuzumab
Kura Oncology, Inc.KURA5PHASE3Ziftomenib, Venetoclax, Azacitidine, Daunorubicin, Cytarabine
Syndax Pharmaceuticals IncSNDX4PHASE3Revumenib, Intensive Chemotherapy Regimen, revumenib, cobicistat, SNDX-5613
Takeda Pharmaceutical Co. Ltd. Sponsored ADRTAK1PHASE3Ponatinib, Imatinib, Vincristine, Dexamethasone, Cytarabine
SELLAS Life Sciences Group, Inc.SLS1PHASE3Galinpepimut-S, Azacitidine, Venetoclax, Decitabine, Cytarabine
Grifols, S.A. Sponsored ADR Class BGRFS1PHASE3Xembify
Bristol-Myers Squibb CompanyBMY7PHASE2Azacitidine, CC-486, AG-120, AG-221, BMS-986497
Pfizer Inc.PFE6PHASE2Gemtuzumab ozogamicine - Cytarabine - Gilteritinib, Inotuzumab ozogamicin, ALLR3, SEA-CD70, azacitidine
Incyte CorporationINCY6PHASE2Ruxolitinib, Conditioning Regimen A, Conditioning Regimen B, Conditioning Regimen C, Conditioning Regimen D
Tango Therapeutics, Inc.TNGX7PHASE3AG-120, Azacitidine, Ivosidenib, Ivosidenib + azacitidine, BN104 monotherapy
Ascentage Pharma Group International Unsponsored ADRAAPG11PHASE3Olverembatinib, Imatinib, Lisaftoclax, Acalabrutinib, Fludarabine
Actinium PharmaceuticalsATNM2PHASE3Iomab-B, Conventional Care, 131I-apamistamab, Fludarabine, Cyclophosphamide
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