RecruitingPhase 1Phase 2NCT06182696
OriCAR-017 Chimeric Antigen Receptor (CAR) Modified T Cells for the Treatment of R/RMM
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
Sponsor
OriCell Therapeutics Co., Ltd.
Enrollment
83 participants
Start Date
Oct 26, 2023
Study Type
INTERVENTIONAL
Conditions
Summary
An open label, dose exploratory clinical study to evaluate the safety, efficacy, and pharmacokinetics of OriCAR-017 in R/RMM
Eligibility
Min Age: 18 YearsMax Age: 75 Years
Inclusion Criteria9
- 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.
Exclusion Criteria14
- 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.
Interventions
BIOLOGICALOriCAR-017
GPCRC5D-directed chimeric antigen receptor modified T cells
Locations(5)
View Full Details on ClinicalTrials.gov
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NCT06182696