Status:
RECRUITING
OriCAR-017 Chimeric Antigen Receptor (CAR) Modified T Cells for the Treatment of R/RMM
Lead Sponsor:
OriCell Therapeutics Co., Ltd.
Conditions:
Relapsed and/or Refractory Multiple Myeloma
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
PHASE2
Brief Summary
An open label, dose exploratory clinical study to evaluate the safety, efficacy, and pharmacokinetics of OriCAR-017 in R/RMM
Detailed Description
This is a Phase I and Phase II, open-label, multi-center study to assess the safety, pharmacokinetics, and efficacy of GPRC5D directed chimeric antigen receptor modified T cells injection (OriCAR-017)...
Eligibility Criteria
Inclusion
- 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 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
- 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.
Key Trial Info
Start Date :
October 26 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 31 2028
Estimated Enrollment :
83 Patients enrolled
Trial Details
Trial ID
NCT06182696
Start Date
October 26 2023
End Date
August 31 2028
Last Update
May 31 2024
Active Locations (5)
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1
The First Affiliated Hospital College of Medicine Zhejiang University
Hangzhou, Zhejiang, China, 310003
2
Beijing GoBroad Hospital
Beijing, China
3
The First Affiliated Hospital with Nanjing Medical University
Nanjing, China
4
Tongji Hospital of Tongji University
Shanghai, China