A Study to Evaluate the Safety, PK/PD of (OriCAR-017) in Subjects With RR/MM - RIGEL Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: OriCAR-017.
- Who it may be relevant to
- Registry conditions: Neoplasms, Plasma Cell, Neoplasms by Histologic Type, Neoplasms, Hemostatic Disorders. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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.
Overview
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.
Interventions
- Drug OriCAR-017
Anti-GPRC5D CAR-T cell product
Primary outcome measures
- Maximum tolerated dose (MTD) of OriCAR-017 US-P1 [Time frame: Up to 28 days]
- Dose-limiting toxicity (DLT) [Time frame: Up to 28 days]
Secondary outcome measures (9)
- Evaluate PK parameters of OriCAR-017 in subjects with relapsed/refractory MM [Time frame: Up to 2 years]
- Evaluate PD parameters of OriCAR-017 in subjects with relapsed/refractory MM [Time frame: Up to 2 years]
- Assessment of Duration of Response (DOR) of treatment in patients with RR/MM [Time frame: Up to 2 years]
- Progress-Free Survival (PFS) of treatment in patients with RR/MM [Time frame: Up to 2 years]
- Assessment of Overall Survival (OS) of treatment in patients with RR/MM [Time frame: Up to 2 years]
- Assessment of MRD negative Rate [Time frame: Up to 2 years]
- Assessment of Overall Response Rate (ORR) [Time frame: Up to 2 years]
- Assessment of Disease Control Rate (DCR) [Time frame: Up to 2 years]
- Assessment of Clinical Benefit Rate (CBR) [Time frame: Up to 2 years]
Eligibility criteria
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.
For Phase I (dose-expansion) and Phase II: Subjects with previous exposure to BCMA directed therapies including BCMA bispecific antibody (e.g., teclistamab), BCMA antibody directed conjugate (such as BLENREP), and BCMA-CAR-T (such as CARVYKT1TM)
Subjects with adequate hematologic, renal, hepatic, pulmonary and cardiac function.
Subject and partners willing to take and or use effective contraceptive measures until 2 years post IMP infusion.
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Northside Hospital — Atlanta
Identifiers
NCT: NCT06271252 · OriCAR-017-US-P1