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TC-110 T Cells

Phase 1

Non Hodgkin Lymphoma | Small molecule | Oncology |Adaptimmune Therapeutics PLC Sponsored ADR|Last Updated: Mar 16, 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 Enrollment6
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04323657TC-110 T Cells in Adults With Relapsed or Refractory Non-Hodgkin Lymphoma or Acute Lymphoblastic LeukemiaPHASE1 COMPLETED 6Mar 27, 2020Feb 24, 2023Mar 16, 20233 United States
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Study Endpoints
Primary Endpoints
Establish the recommended phase 2 dose (RP2D) for the NHL and ALL indications according to the observed adverse events, including potential dose-limiting toxicities (DLT).
DLTs within 28 days post-treatment
To evaluate the efficacy of autologous genetically modified TC-110 T cells in adult patients with R/R NHL as determined by overall response rate (ORR)
ORR at 3 months for NHL patients at 3 months
To evaluate the efficacy of autologous genetically modified TC-110 T cells in adult patients with R/R ALL as determined by overall response rate and Minimum Residual Disease (MRD) negativity rates
ORR rate and MRD negativity rate for ALL patients at 3 months
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Phase 1EXPERIMENTALThe Phase 1 portion of the study will proceed according to a standard 3 + 3 dose escalation schema. Patients will be enrolled into 3 cohorts based on disease: NHL cohort, low tumor burden ALL cohort, and high tumor burden ALL cohort.
Phase 2EXPERIMENTALThe phase 2 portion of the study will evaluate the efficacy of TC-110 T cells administered at the RP2D, preceded by a lymphodepleting regimen.
Interventions
NameTypeDescription
TC-110 T CellsDRUGTC-110 T Cells
FludarabineDRUGFlu/Cy Lymphodepletion
CyclophosphamideDRUGFlu/Cy Lymphodepletion
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites3

Inclusion Criteria: * Patient is \> 18 years of age at the time the Informed Consent is signed * Patient has agreed to abide by all protocol-required procedures, including study-related assessments, and management by the treating institution for the duration of the study and LTFU * Histologically c...

Countries:United States
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