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Tests treatment safety and results for Neoplasms, Plasma Cell
Official title A Study to Evaluate the Safety, PK/PD of (OriCAR-017) in Subjects With RR/MM - RIGEL Study
ClinicalTrials.gov ID: NCT06271252
What this study is testing
What is OriCAR-017?
OriCAR-017 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for neoplasms, plasma cell.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Capable of giving signed informed consent
- people 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:
You likely can't join 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...
- Presence of uncontrolled active infection
- people who received autologous hematopoietic stem cell transplantation (ASCT) within 8 weeks of Screening Visit or who plan to undergo ASCT during...
See the full eligibility criteria
- Capable of giving signed informed consent
- people 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) - people 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: people with previous exposure to BCMA directed therapies including BCMA bispecific antibody (e.g., teclistamab), BCMA antibody directed conjugate (such as BLENREP), and...
- people 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.
- 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...
- Presence of uncontrolled active infection
- people who received autologous hematopoietic stem cell transplantation (ASCT) within 8 weeks of Screening Visit or who plan to undergo ASCT during the study.
- people 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.
The study team makes the final eligibility decision.
Where it's taking place
- Atlanta, Georgia, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Atlanta, Georgia, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.