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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
BCMA-Targeted Chimeric Antigen Receptor Autologous T-cell
Biological/VaccineChimeric Antigen Receptor Autologous T-cell
Treatment groups
12 Participants
are divided into 1 treatment groupGroup A: Treatment group CG-105-12Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
The incidence of dose-limiting toxicity (DLT).
Time frame
Day 0~ 28 after treatment with CG-105-12 injection（D0）2
Adverse event related laboratory tests, vital signs, physical examination
Time frame
Up to 12 months after treatment with CG-105-12 injectionSecondary outcomes
1
Objective response rate (ORR);
Proportion of subjects with multiple myeloma receiving response(sCR,CR, VGPR or PR) after treatment with CG-105-12 injection
Time frame
Up to 12 months following CG-105-12 injection2
Duration of remission (DOR) after administration;
Time from the first assessment of PR and above for multiple myeloma to the first assessment of disease progression or death from any cause
Time frame
Up to 12 months following CG-105-12 injection3
Progression free survival (PFS);
Time from the beginning of treatment with CG-105-12 to the first disease progression or death from any cause
Time frame
Up to 12 months after treatment with CG-105-12 injection4
Overall survival (OS)
Time from receiving CG-105-12 treatment(Day0) to death (for any reason)
Time frame
Up to 15 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
The First Affiliated Hospital of Nanchang University
Lead sponsor
Cells & Genes Biotech (Shanghai) Co.,Ltd
Collaborator
Source ClinicalTrials.gov