RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

A Phase I/II, Open-label, Multicenter Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of Anti-GPRC5D CAR-T Cell Product (OriCAR-017) in Subjects With Relapsed/Refractory Multiple Myeloma.

Quick Facts

Study Start:2024-04-03
Study Completion:2028-04-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06271252

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 75 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Locations (Sites)

Northside Hospital
Atlanta, Georgia, 30342
United States

Collaborators and Investigators

Sponsor: OriCell Therapeutics Co., Ltd.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-04-03
Study Completion Date2028-04-12

Study Record Updates

Study Start Date2024-04-03
Study Completion Date2028-04-12

Terms related to this study

Keywords Provided by Researchers

  • R/R MM, CAR-T

Additional Relevant MeSH Terms

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