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RECRUITINGPHASE1

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

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.

NCT06271252•OriCell Therapeutics Co., Ltd.

View on ClinicalTrials.gov

Summary

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

Detailed Description

This is 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". The study will consist of a Phase I dose escalation stage involving three doses as a single IV infusion) with up to 18 evaluable subjects and a dose expansion stage with 10-15 evaluable subjects, followed by a Phase II stage with up to 48 evaluable subjects.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Capable of giving signed informed consent
•Subjects aged 18 to 75 years (inclusive) at Screening (signing the ICF).
•Expected survival period is \>12 weeks.
•Diagnosis of MM according to the IMWG criteria (2016 version).
•One of the following criteria must be met:
•If immunoglobulin (Ig)G type MM, then serum M protein \>10 g/L; if IgA, IgD, IgE or IgM type MM, then serum M protein \>5 g/L
•Urine M protein level \>200 mg/24 hour
•If light chain type MM, then serum free light chain (sFLC) \>100 mg/L and K/λ FLC ratio is abnormal.
•Extramedullary lesions (\>1 cm for diameter of the short axis).
•For Phase I (dose-escalation) - Subjects who had received at least 3 prior lines of therapy, had previous exposure to BCMA-Ag+ therapies, and were refractory to the last line of therapy.
+3 more criteria

Exclusion Criteria

•Pregnant or breastfeeding.
•Seropositive for history of human immunodeficiency virus Active Hepatitis B infection and or Hepatitis C infection
•Known active or prior history of CNS involvement
•History of autoimmune diseases (such as Crohn's disease, rheumatoid arthritis, systemic lupus erythematosus) caused damage to terminal organs or required systemic application of immunosuppressive or other drugs in the past 2 years
•Presence of uncontrolled active infection
•Subjects who received autologous hematopoietic stem cell transplantation (ASCT) within 8 weeks of Screening Visit or who plan to undergo ASCT during the study.
•Subjects who received allogeneic stem cell therapy.
•Any condition that in the opinion of the Investigator, would interfere with evaluation of the IMP.
•Received Bendamustine treatment 1 year prior to Screening Visit.

Locations (1)

Northside Hospital

Atlanta, Georgia, United States

Key Dates

Start Date

April 3, 2024

Primary Completion Date

December 12, 2026

Completion Date

April 12, 2028

Last Updated

August 2, 2024

Enrollment

ESTIMATED participants

Conditions

Neoplasms, Plasma CellNeoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemorrhagic DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune System DiseasesMultiple Myeloma

Interventions

OriCAR-017

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 2, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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