Clinical trial NCT06271252: A Study to Evaluate the Safety, PK/PD of (OriCAR-017) in Subjects With RR/MM - 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.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: 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
Keywords: R/R MM, CAR-T
Lead sponsor: OriCell Therapeutics Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-02-21
Enrollment: 81
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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 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.

Primary outcomes:
measure: Maximum tolerated dose (MTD) of OriCAR-017 US-P1
timeFrame: Up to 28 days
measure: Dose-limiting toxicity (DLT)
timeFrame: Up to 28 days
Secondary outcomes:
measure: Evaluate PK parameters of OriCAR-017 in subjects with relapsed/refractory MM
timeFrame: Up to 2 years
measure: Evaluate PD parameters of OriCAR-017 in subjects with relapsed/refractory MM
timeFrame: Up to 2 years
measure: Assessment of Duration of Response (DOR) of treatment in patients with RR/MM
timeFrame: Up to 2 years
measure: Progress-Free Survival (PFS) of treatment in patients with RR/MM
timeFrame: Up to 2 years
measure: Assessment of Overall Survival (OS) of treatment in patients with RR/MM
timeFrame: Up to 2 years
measure: Assessment of MRD negative Rate
timeFrame: Up to 2 years
measure: Assessment of Overall Response Rate (ORR)
timeFrame: Up to 2 years
measure: Assessment of Disease Control Rate (DCR)
timeFrame: Up to 2 years
measure: Assessment of Clinical Benefit Rate (CBR)
timeFrame: Up to 2 years
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Northside Hospital
state: Georgia
Study officials:
References: