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CAR2 Anti-CD38 A2 CAR-T Cells

Phase 1

Relapsed or Refractory Multiple Myeloma | Cell Therapies | Oncology |Sorrento Therapeutics, Inc.|Trials Updated: Mar 16, 2022

CAR2 Anti-CD38 A2 CAR-T Cells development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Mar 2018

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment10

FDA Designations

No designations recorded

CAR2 Anti-CD38 A2 CAR-T Cells clinical trials

CAR2 Anti-CD38 A2 CAR-T Cells · 1 trial · 1 indication

Phase 1 1
NCT03464916Study to Evaluate the Safety and Efficacy of Anti-CD38 CAR-T in Relapsed or Refractory Multiple Myeloma PatientsRelapsed or Refractory Multiple Myeloma
COMPLETED10 Analytics
PHASE1COMPLETED
Study to Evaluate the Safety and Efficacy of Anti-CD38 CAR-T in Relapsed or Refractory Multiple Myeloma Patients
Relapsed or Refractory Multiple MyelomaUnlock trial analytics

Study Endpoints

Primary Endpoints

Determine the MTD
28 days

The MTD is assessed according to a 3+3 dose-escalation design by the occurrence of treatment-emergent dose-limiting toxicities during the 28-day Treatment Period in the dose-escalation phase of the study

Secondary Endpoints

Determine the CAR2 Anti-CD38 A2 CAR-T cell blood concentrations (Pharmacokinetic [PK] Profile) to evaluate the Cmax
28 days
Determine the CAR2 Anti-CD38 A2 CAR-T cell blood concentrations (Pharmacokinetic [PK] Profile) to evaluate the AUC
28 days
Evaluate the safety of Anti-CD38 A2 CAR-T cells in Patients with RRMM by incidence of treatment-emergent adverse events
6 months
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
CAR2 Anti-CD38 A2 CAR-T CellsEXPERIMENTALRelapsed or Refractory Multiple Myeloma

Interventions

NameTypeDescription
CAR2 Anti-CD38 A2 CAR-T CellsBIOLOGICALAutologous IV infusion; dose-escalation
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites4

Inclusion Criteria: * The patient must either have relapsed refractory multiple myeloma (RRMM) after receiving prior lines of anti-myeloma treatments that included at least lenalidomide (Revlimid®), pomalidomide (Pomalyst®), bortezomib (Velcade®), carfilzomib (Kyprolis®), and daratumumab (Darzalex®...

Countries:United States
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Competitive Landscape -Multiple Myeloma 338 trials (matched to "Relapsed or Refractory Multiple Myeloma")

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