Tests OriCAR-017 cell therapy in adults with relapsed or refractory multiple myeloma
Tests modified T cells targeting GPRC5D in adults with returned or resistant myeloma.
Plain-language title generated from the registry record
Registry title: OriCAR-017 Chimeric Antigen Receptor (CAR) Modified T Cells for the Treatment of R/RMM
Key facts
- Where
- Beijing, Hangzhou, Nanjing, Shanghai, and Wuhan, ChinaSee the 5 sites
- Phase
- Phase 1/2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Source: NCT06182696, who can take part
Where in China
- Beijing GoBroad HospitalBeijing, ChinaNot yet recruiting
- The First Affiliated Hospital, College of Medicine, Zhejiang UniversityHangzhou, ChinaTaking people
- The First Affiliated Hospital with Nanjing Medical UniversityNanjing, ChinaNot yet recruiting
- Tongji Hospital of Tongji UniversityShanghai, ChinaNot yet recruiting
- Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyWuhan, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- OriCell Therapeutics Co., Ltd.
- Trial code
- NCT06182696
- Record updated
- 31 May 2024
- Original description
An open label, dose exploratory clinical study to evaluate the safety, efficacy, and pharmacokinetics of OriCAR-017 in R/RMMRead full original descriptionShow less
An Open Label,Multi-center Study to Evaluate the Safety, Pharmacokinetics and Efficacy of Autologous T Cell Injection Targeting GPRC5D OriCAR-017 in Patients With Relapsed and/or Refractory Multiplemyeloma
An open label, dose exploratory clinical study to evaluate the safety, efficacy, and pharmacokinetics of OriCAR-017 in R/RMM
Main Inclusion Criteria:; 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 met:; 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; Subjects 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 those who have experienced relapse (within 12 months), refractory or intolerant to the last line treatment regimen; Main Exclusion Criteria:; 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; human immunodeficiency virus (HIV) antibody positive; syphilis antibody is positive at Screening; Cytomegalovirus DNA test 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; Subjects 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; Subjects who received allogeneic stem cell therapy; Subjects 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.