An Exploratory Clinical Study on the Safety and Efficacy of Autologous T Cell Injection Targeting BCMA Chimeric Antigen Receptor (CG-105-12) in the Treatment of Patients With Relapsed / Refractory Multiple Myeloma

Status: Recruiting
Location: See location...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Early Phase 1
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 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;

• 4.One of the following is met (all data below are compared to the obtained minimum values):

• \- 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);

• \- b. Uroprotein increased by more than 25% (absolute increase greater than 200 mg/24h);

• \- c. The difference between affected and unaffected serum FLC increased by more than 25% and the absolute value increased by more than 100 mg/L;

• \- d.The proportion of bone marrow plasma cells increased by more than 25% and the absolute value increased by more than 10%;

• \- e. The sum of the original maximum vertical diameter products of more than one measurable lesion increased by at least 50% from the lowest point; or the long axis of the original lesion of at least 1 cm increased by at least 50%;

• \- f. An increase in circulating plasma cells of at least 50% (used when only circulating plasma cells are measurable lesions, with an absolute value of at least 200 cells per microlitre);

• 5.ECOG performance status score of 0-2;

• 6.Expected survival ≥12 weeks;

• 7.Subjects must have adequate organ function and meet all of the following laboratory test results prior to enrollment:

• \- a.Complete blood count: Neutrophil count (ANC) 1E9/L; Lymphocyte count (ALC) 0.5E9/L; Platelet count \>50E9/L; Haemoglobin \>60g/L or Haematocrit \>0.24;

• \- b.Liver function: Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) less than 2.5 times the upper limit of normal (ULN); serum total bilirubin less than 1.5 times the ULN;

• \- c.Renal function: The creatinine clearance rate calculated according to the Cockcroft-Gault formula is GFR 40ml/min (except for those whose renal function is abnormal due to progression of the primary disease as judged by the investigator);

• \- d.Coagulation function: fibrinogen ≥ 1.0 g/L; activated partial thromboplastin time ≤1.5×ULN, prothrombin time (PT) ≤ 1.5×ULN;

• \- e.Blood oxygen saturation \> 91%;

• \- f.Left ventricular ejection fraction (LVEF) ≥ 50%;

• 8.Subjects and their spouses agreed to use effective instrumental or medical contraception (except for safe contraception) from the time of signing the informed consent form until one year after CAR-T cell reinfusion;

• 9.Participants must personally sign a written informed consent form approved by the Ethics Committee prior to the start of any screening procedure.

Locations
Other Locations
China
The First Affiliated Hospital of Nanchang University
RECRUITING
Nanchang
Contact Information
Primary
BaoQuan Song
ndyfy07309@ncu.edu.cn
+8615962453016
Backup
Lingling Xu
xulingling@cellsgenes.com
+8613799123760
Time Frame
Start Date: 2024-09-05
Estimated Completion Date: 2027-09-30
Participants
Target number of participants: 12
Treatments
Experimental: Treatment group CG-105-12
Biological: BCMA-Targeted Chimeric Antigen Receptor Autologous T-cell
Sponsors
Collaborators: Cells & Genes Biotech (Shanghai) Co.,Ltd
Leads: The First Affiliated Hospital of Nanchang University

This content was sourced from clinicaltrials.gov