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

NCT06271252 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: OriCAR-017-US-P1
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

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

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

Outcome Measures

Primary Outcomes (2)

• Maximum tolerated dose (MTD) of OriCAR-017 US-P1

  The MTD is defined as the highest dose with an observed incidence of DLT in no more than one out of six patients treated at a particular dose level.

  Up to 28 days

• Dose-limiting toxicity (DLT)

  A DLT is defined as any of the treatment-emergent adverse events (TEAEs; a TEAE is defined as an adverse event \[AE\] that starts on or after the first administration of study medication) condition or concomitant medications.

  Up to 28 days

Secondary Outcomes (9)

• Evaluate PK parameters of OriCAR-017 in subjects with relapsed/refractory MM

  Up to 2 years

• Evaluate PD parameters of OriCAR-017 in subjects with relapsed/refractory MM

  Up to 2 years

• Assessment of Duration of Response (DOR) of treatment in patients with RR/MM

  Up to 2 years

• Progress-Free Survival (PFS) of treatment in patients with RR/MM

  Up to 2 years

• Assessment of Overall Survival (OS) of treatment in patients with RR/MM

  Up to 2 years

Study Arms (1)

OriCAR-017

EXPERIMENTAL

Single OriCAR-017 infusion

Drug: OriCAR-017

Interventions

OriCAR-017 DRUG

Anti-GPRC5D CAR-T cell product

OriCAR-017

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• OriCell Therapeutics Co., Ltd.: lead

Study Sites (1)

Northside Hospital

Atlanta, Georgia, 30342, United States

RECRUITING

MeSH Terms

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

Condition Hierarchy (Ancestors)

Hemic and Lymphatic Diseases; Lymphatic Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 26, 2024
• First Posted: February 21, 2024
• Study Start: April 3, 2024
• Primary Completion (Estimated): December 12, 2026
• Study Completion (Estimated): April 12, 2028
• Last Updated: August 2, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)