A Study to Evaluate CG-105-12 in Patients With Relapsed/Refractory Multiple Myeloma
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorThe First Affiliated Hospital of Nanchang University
About this trial
This study is a single-centre, single-arm, open-label, dose-escalation exploratory study with single-dose administration. Its objective is to evaluate the safety, tolerability, dose, anti-tumor efficacy, and pharmacokinetic characteristics of CG-105-12 in the participants with BCMA-positive relapsed/refractory multiple myeloma who previously received adequate but uneffective standard treatments.
Eligibility criteria
Qualifiers
1.Aged 18-75 years (inclusive of 18 and 75 years old), gender not limited;
2.Subject has received at least 3 lines of therapy, including at least proteasome inhibitors (PIs) and immunomodulatory therapy (IMiD); disease relapse, progression, or refractory according to the International Myeloma Working Group (IMWG) Consensus (2016) criteria for multiple myeloma;
3.Subjects whose tumor specimens were positive for BCMA expression on the membrane surface of plasma cells by immunohistochemistry (IHC) or flow cytometry and had not received prior BCMA CAR-T therapy;
- a. Serum M-protein increased by more than 25% (absolute increase greater than 5 g/L) or M-protein increased by more than 10 g/L (if baseline serum M-protein is greater than 50 g/L);
Disqualifiers
1.Hepatitis B surface antigen (HBsAg) positive, or Hepatitis B core antibody (HBcAb) positive with detectable Hepatitis B Virus (HBV) DNA in peripheral blood; Hepatitis C Virus (HCV) antibody positive with peripheral blood positive for Hepatitis C Virus (HCV) RNA; Human Immunodeficiency Virus (HIV) antibody positive; and Syphilis test positive.
- a.Treatment of multiple myeloma with monoclonal antibodies, CNS radiotherapy within 8 weeks prior to single nucleated cell collection;
- b.or cytotoxic chemotherapy, immunomodulator therapy, or proteasome inhibitor therapy within 14 days prior to single nucleated cell collection;
- c.or have received granulocyte-macrophage colony-stimulating factor (GM-CSF), long-acting granulocyte colony-stimulating factor (G-CSF) within 14 days prior to the single nucleated cell collection;
Trial design
Treatments tested in this trial
- BCMA-Targeted Chimeric Antigen Receptor Autologous T-cell
Treatment groups
12 Participants
are divided into 1 treatment groupSponsors and collaborators
The First Affiliated Hospital of Nanchang University
Lead sponsor
Cells & Genes Biotech (Shanghai) Co.,Ltd
Collaborator
Source ClinicalTrials.gov