BridgeMD
New treatment option for Relapsed and/or Refractory Multiple Myeloma
Official title OriCAR-017 Chimeric Antigen Receptor (CAR) Modified T Cells for the Treatment of R/RMM
ClinicalTrials.gov ID: NCT06182696
What this study is testing
What is OriCAR-017?
OriCAR-017 is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for relapsed and/or refractory multiple myeloma.
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
- An open label, dose exploratory clinical study to evaluate the safety, efficacy, and pharmacokinetics of OriCAR-017 in R/RMM
- Phase 2: a mid-size study of how well it works
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
- Main
- Diagnosis of R/RMM according to the IMWG criteria;
- Expected survival period is \>12 weeks;
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 or 2 at the time of ICF signature;
- The expression of GPRC5D in bone marrow plasma cells membrane is more than 20% by flow cytometry and/or immunohistochemistry, multiple myeloma with...
You likely can't join if
- Smoldering myeloma (asymptomatic)
- Multiple myeloma with only extramedullary lesions;
- Plasma cell leukemia;
- Concurrent amyloidosis;
- Central nervous system metastasis, leptomeningeal disease or metastatic central compression;
- HBsAg or HbcAb is positive, and the quantitative detection of hepatitis B virus (HBV) DNA in peripheral blood is more than 100 copies/L; hepatitis C...
See the full eligibility criteria
- Main
- Diagnosis of R/RMM according to the IMWG criteria;
- Expected survival period is \>12 weeks;
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 or 2 at the time of ICF signature;
- The expression of GPRC5D in bone marrow plasma cells membrane is more than 20% by flow cytometry and/or immunohistochemistry, multiple myeloma with measurable lesions, and at least one of the following criteria must be...
- Serum M protein \>5 g/L;
- Urine M protein level \>200 mg/24 hour;
- Serum free light chain (sFLC) \>100 mg/L and K/λ FLC ratio is abnormal;
- Primitive immature or monoclonal plasma cells \>5% by bone marrow cytology or flow cytometry.
- people who had received at least 3 prior lines of therapy including (but not limited to) immunomodulatory drugs (IMiDs), proteasome inhibitors, anti-CD38 monoclonal antibodies, etc., but have failed treatment, including...
- Smoldering myeloma (asymptomatic)
- Multiple myeloma with only extramedullary lesions;
- Plasma cell leukemia;
- Concurrent amyloidosis;
- Central nervous system metastasis, leptomeningeal disease or metastatic central compression;
- HBsAg or HbcAb is positive, and the quantitative detection of hepatitis B virus (HBV) DNA in peripheral blood is more than 100 copies/L; hepatitis C virus (HCV) antibody and HCV RNA in peripheral blood is positive...
- Had hypersensitivity or intolerance to any drug/excipient (including conditioning chemotherapy) used in this study;
- Previously received treatment targeting GPRC5D, including but not limited to antibodies, ADC, or CAR-T;
- people who received autologous hematopoietic stem cell transplantation (ASCT) within 8 weeks of Screening Visit or who plan to undergo ASCT during the study;
- Any uncontrolled active infection within 4 weeks prior to ICF signing or leukapheresis requires parenteral antibiotic, antiviral, or antifungal treatment
- Major surgery within 28 days prior to Screening Visit with the exception of a biopsy and an insertion of a central venous catheter or during the study;
- people who received allogeneic stem cell therapy;
- people complications or other conditions evaluated by investigators may affect compliance with the protocol or make them unsuitable to participate in this study;
- Pregnant or breastfeeding.
The study team makes the final eligibility decision.
Where it's taking place
- Hangzhou, Zhejiang, China
- Beijing, China
- Nanjing, China
- Shanghai, China
- Wuhan, China
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 Hangzhou, Zhejiang, China; Beijing, China; Nanjing, China; Shanghai, China; Wuhan, China. 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.