Evaluating a new CAR-T cell therapy for relapsed/refractory multiple myeloma
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.
This study is testing a new CAR-T cell therapy called OriCAR-017 to see if it can help people with relapsed or refractory multiple myeloma feel better and improve their treatment outcomes.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 81 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | OriCell Therapeutics Co., Ltd. Industry-sponsored |
| Drugs / interventions | teclistamab, CAR-T |
| Locations | 1 site (Atlanta, Georgia) |
| Trial ID | NCT06271252 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to assess the safety, pharmacokinetics, pharmacodynamics, and preliminary efficacy of OriCAR-017, an anti-GPRC5D CAR-T cell therapy, in patients with relapsed or refractory multiple myeloma. The study is structured in phases, starting with a dose escalation involving a small group of subjects, followed by a dose expansion and a larger Phase II stage. Participants will receive the therapy through a single intravenous infusion, and the study will monitor their responses and any adverse effects.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 75 with relapsed or refractory multiple myeloma who have received multiple prior therapies.
Not a fit: Patients who have not been diagnosed with multiple myeloma or those who have not received prior BCMA-directed therapies may not benefit from this study.
Why it matters
Potential benefit: If successful, this therapy could provide a new treatment option for patients with difficult-to-treat multiple myeloma.
How similar studies have performed: Other studies involving CAR-T therapies for multiple myeloma have shown promising results, indicating potential for success with this approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Atlanta, Georgia
- Northside Hospital — Atlanta, Georgia, United States (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.