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PRGN-3005

Phase 1

Platinum-Resistant Fallopian Tube Carcinoma | Monoclonal antibody | Oncology |Precigen, Inc.|Last Updated: Nov 8, 2024

Target and mechanism

ModalityMonoclonal antibody

Also known as PRGN-3005 UltraCAR-T cells

Success Probability

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Market & Valuation

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Trial Design

CONTROLLEDDMC
Total Trials1
Total Enrollment71

FDA Designations

No designations recorded

Clinical trial landscape

PRGN-3005 · 1 trial · 34 indications

Phase 1 1
NCT03907527Modified Immune Cells (Autologous CAR T Cells) in Treating Patients with Advanced, Recurrent Platinum Resistant Ovarian, Fallopian Tube or Primary Peritoneal CancerPlatinum-Resistant Fallopian Tube Carcinoma
ACTIVE NOT_RECRUITING71 Analytics
PHASE1ACTIVE NOT_RECRUITING
Modified Immune Cells (Autologous CAR T Cells) in Treating Patients with Advanced, Recurrent Platinum Resistant Ovarian, Fallopian Tube or Primary Peritoneal Cancer
Platinum-Resistant Fallopian Tube CarcinomaUnlock trial analytics

Study Endpoints

Primary Endpoints

Incidence of adverse events
Up to 12 months after infusion

Toxicity grading will be evaluated according to the Cancer Therapy Evaluation Program Common Terminology Criteria for Adverse Events version 5.0 and monitoring of adverse events

Maximal tolerated dose of PRGN-3005
Up to 28 days

Will be determined by a 3 X 3 dose escalation study for both intraperitoneal infusion and intravenous infusion of the trial.

Secondary Endpoints

Evidence of anti-tumor activity
Up to 5 years
Number of PRGN-3005 T Cells
Up to 12 months post treatment
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Treatment (PRGN-3005 UltraCAR-T cells) IP AdministrationEXPERIMENTALPatients receive autologous PRGN-3005 UltraCAR-T cells via IP administration with or without lymphodepleting chemotherapy.
Treatment (PRGN-3005 UltraCAR-T cells) IV AdministrationEXPERIMENTALPatients receive autologous PRGN-3005 UltraCAR-T cells via IV administration with or without lymphodepleting chemotherapy.

Interventions

NameTypeDescription
PRGN-3005 UltraCAR-T cellsBIOLOGICALGiven IP
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Eligibility Criteria

Age Range18 Years to N/A
SexFEMALE
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: * Women with recurrent, advanced, platinum resistant ovarian, fallopian tube, and primary peritoneal cancer that have progressed after receiving standard of care therapies or are not eligible to receive available therapies with known clinical benefit will be eligible for the stu...

Countries:United States
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