CAR T-cell therapy for treating relapsed multiple myeloma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the safety, efficacy, and pharmacokinetics of OriCAR-017, a chimeric antigen receptor modified T cell therapy, in patients with relapsed and/or refractory multiple myeloma (R/RMM). It is an open-label, multi-center study that includes both Phase I and Phase II components. Participants will receive injections of OriCAR-017, and the study aims to determine how well this treatment works and its safety profile. The trial will assess patients who meet specific criteria related to their disease and prior treatments.

Why it matters

Who can join: the full rules

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:

  1. Serum M protein \>5 g/L;
  2. Urine M protein level \>200 mg/24 hour;
  3. Serum free light chain (sFLC) \>100 mg/L and K/λ FLC ratio is abnormal;
  4. 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.

Where it's running

• The First Affiliated Hospital College of Medicine Zhejiang University
  Hangzhou, Zhejiang, China Recruiting
• Union Hospital Tongji Medical College Huazhong University of Science and Technology
  Wuhan, China Recruiting
• Beijing GoBroad Hospital
  Beijing, China Not yet recruiting
• The First Affiliated Hospital with Nanjing Medical University
  Nanjing, China Not yet recruiting
• Tongji Hospital of Tongji University
  Shanghai, China Not yet recruiting

Study contacts

• Study coordinator: HE Huang, MD
• Email: hehuangyu@126.com
• Phone: 0571-88208277

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.