CAR T-cell therapy for treating relapsed multiple myeloma

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

This study is testing a new type of immune therapy called OriCAR-017 to see if it can help people with relapsed multiple myeloma feel better and improve their treatment outcomes.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 83 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: OriCell Therapeutics Co., Ltd. (Industry-sponsored)
• Drugs / interventions: CAR-T, chemotherapy, chimeric antigen receptor
• Locations: 5 sites (Hangzhou, Zhejiang and 4 other locations)
• Trial ID: NCT06182696 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults diagnosed with relapsed and/or refractory multiple myeloma who have undergone at least three prior lines of therapy.

Not a fit: Patients with early-stage multiple myeloma or those who have not received prior treatments may not benefit from this study.

Why it matters

Potential benefit: If successful, this therapy could provide a new treatment option for patients with difficult-to-treat relapsed multiple myeloma.

How similar studies have performed: Other studies using CAR T-cell therapies for multiple myeloma have shown promising results, indicating potential for success in this approach.

Eligibility criteria

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 this trial is running

Hangzhou, Zhejiang and 4 other locations

• The First Affiliated Hospital College of Medicine Zhejiang University — Hangzhou, Zhejiang, 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)
• Union Hospital Tongji Medical College Huazhong University of Science and Technology — Wuhan, China (Recruiting)

Study contacts

• Study coordinator: HE Huang, MD

Conditions Relapsed and/or Refractory Multiple Myeloma