A Study to Evaluate the Safety, PK/PD of (OriCAR-017) in Subjects With RR/MM - RIGEL Study

Part of paid clinical trials in Atlanta, Georgia.

Sponsor
OriCell Therapeutics Co., Ltd.
Study ID
NCT06271252
Phase
PHASE1
Status
Recruiting
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Conditions

  • Blood Protein Disorders
  • Cardiovascular Diseases
  • Hematologic Diseases
  • Hemorrhagic Disorders
  • Hemostatic Disorders
  • Immune System Diseases
  • Immunoproliferative Disorders
  • Lymphoproliferative Disorders
  • Multiple Myeloma
  • Neoplasms
  • Neoplasms by Histologic Type
  • Neoplasms, Plasma Cell
  • Paraproteinemias
  • Vascular Diseases

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • OriCAR-017 — DRUG
    Anti-GPRC5D CAR-T cell product

Study Details

The is a first clinical study for Oricell Therapeutics Inc. in the United States to evaluate the safety, PK, PD and preliminary efficacy of our anti-GPRC5D cell product (OriCAR-017) in subjects with relapsed/refractory multiple myeloma. RIGEL Study

Key Dates

Start date
Apr 3, 2024
Status verified
Aug 2024
Primary completion
Dec 12, 2026
Completion
Apr 12, 2028

Study Design

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

Arms

  • Experimental: OriCAR-017
    Single OriCAR-017 infusion

Primary Outcome Measure

Maximum tolerated dose (MTD) of OriCAR-017 US-P1 [ Time Frame: Up to 28 days ]

Locations (1)

FacilityCityStateZIPSite coordinators
Northside HospitalAtlantaGeorgia30342
Melhem Solh
[email protected]
404-255-1930
Caitlin Guzowski
[email protected]
4042551930

Find similar trials in Atlanta, GA

By condition
Multiple myeloma
By specialty
OncologyBlood cancer
By research site
Northside Hospital· Atlanta, GA

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