Safety and Efficacy of OBX-115 in Advanced Solid Tumors

Part of paid clinical trials in Los Angeles, California.

Sponsor
Obsidian Therapeutics, Inc.
Study ID
NCT06060613
Phase
PHASE1/PHASE2
Status
Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • OBX-115 — BIOLOGICAL
    A tumor sample is obtained from each participant for autologous OBX-115 manufacture. After lymphodepletion including cyclophosphamide and fludarabine, participant will receive OBX-115 infusion, followed by short courses of acetazolamide.

Study Details

This is a study to investigate the safety and efficacy of an investigational OBX-115 regimen in adult participants with advanced solid tumors.

Key Dates

Start date
Oct 25, 2023
Status verified
Apr 2026
Primary completion
Jun 30, 2029
Completion
Jun 30, 2029

Study Design

Enrollment
208 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Participants with advanced solid tumors
    Participants will receive conditioning therapy prior to administration of OBX-115 regimen.

Primary Outcome Measure

Incidence and nature of dose-limiting toxicities (DLTs) [ Time Frame: 28 Days ]

Central Contacts

Locations (9)

FacilityCityStateZIPSite coordinators
The Angeles Clinic and Research Institute (Melanoma)Los AngelesCalifornia90025
Saba Mukarram
Omid Hamid, MD (PRINCIPAL_INVESTIGATOR)
USC Norris Comprehensive Cancer Center (Melanoma/NSCLC)Los AngelesCalifornia90033
Sandy Tran
323-865-3935
Gino In, MD (PRINCIPAL_INVESTIGATOR)
Stanford Cancer Institute (Melanoma/NSCLC)StanfordCalifornia94305
Samantha Lam
650-736-3054
Allison Betof, MD (PRINCIPAL_INVESTIGATOR)
Orlando Health Cancer Institute (Melanoma/NSCLC)OrlandoFlorida32806
Karla Ferrer
321-841-6764
Tirrell T. Johnson, MD (PRINCIPAL_INVESTIGATOR)
James Graham Brown Cancer Center (Melanoma/NSCLC)LouisvilleKentucky40202
Melissa B. Hall
Jason Chesney, MD, PhD (PRINCIPAL_INVESTIGATOR)
Memorial Sloan Kettering (Melanoma/NSCLC)New YorkNew York10065
Melanoma
6464979067
NSCLC
6464979163
Alexander Shoushtari, MD (PRINCIPAL_INVESTIGATOR)
The Ohio State UniversityColumbusOhio43210
Miranda Bean
6142934254
Timothy Burns, MD (PRINCIPAL_INVESTIGATOR)
Allegheny Research Institute (Melanoma/NSCLC)PittsburghPennsylvania15224
Lindsay Brown
Thomas Curley, MD (PRINCIPAL_INVESTIGATOR)
M.D. Anderson Cancer Center (Melanoma/NSCLC)HoustonTexas77030
Rodabe Amaria, MD (PRINCIPAL_INVESTIGATOR)

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