A Study to Evaluate CG-105-12 in Patients With Relapsed/Refractory Multiple Myeloma

NCT06999031 | Recruiting Early Phase 1

• 1 other identifier: CG-105-12
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Relapsed/Refractory; Multiple Myeloma

Keywords

multiple myeloma; relapsed/refractory; chimeric antigen receptor T Cell; BCMA

Outcome Measures

Primary Outcomes (2)

• The incidence of dose-limiting toxicity (DLT).

  Day 0~ 28 after treatment with CG-105-12 injection（D0）

• Adverse event related laboratory tests, vital signs, physical examination

  Up to 12 months after treatment with CG-105-12 injection

Secondary Outcomes (9)

• Objective response rate (ORR);

  Up to 12 months following CG-105-12 injection

• Duration of remission (DOR) after administration;

  Up to 12 months following CG-105-12 injection

• Progression free survival (PFS);

  Up to 12 months after treatment with CG-105-12 injection

• Overall survival (OS)

  Up to 15 years

• Time to remission (TTR)

  Up to 12 months after treatment with CG-105-12 injection

Study Arms (1)

Treatment group CG-105-12

EXPERIMENTAL

Biological: BCMA-Targeted Chimeric Antigen Receptor Autologous T-cell

Biological: BCMA-Targeted Chimeric Antigen Receptor Autologous T-cell

Interventions

BCMA-Targeted Chimeric Antigen Receptor Autologous T-cell BIOLOGICAL

Chimeric Antigen Receptor Autologous T-cell

Treatment group CG-105-12

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18-75 years (inclusive of 18 and 75 years old), gender not limited;
• 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;
• 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;
• 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);
• ECOG performance status score of 0-2；
• Expected survival ≥12 weeks；
• 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;

You may not qualify if:

• 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.
• Prior antitumor therapy as follows:
• \- 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;
• Has used therapeutic doses of corticosteroids (defined as prednisone or equivalent \>20 mg/day) within 7 days prior to screening, but physiologic replacement, topical and inhaled steroids are permitted;
• have received treatment containing bendamustine or fludarabine within 12 weeks prior to screening;
• Plasma cell leukemia, patients suspected or suspected of having plasma cell tumor central nervous system invasion during screening;
• patients with previous allogeneic hematopoietic stem cell transplantation;
• malignancies other than multiple myeloma within 5 years prior to screening, excluding adequately treated carcinoma in situ of the cervix, basal cell or squamous epithelial cell skin cancers, localized prostate cancer after radical surgery, and ductal carcinoma in situ of the breast after radical surgery;
• subjects with a history of solid organ transplantation;
• Subjects who have undergone major surgery ( 3 level) within 2 weeks prior to the collection of individual nuclear cells, or who plan to have surgery within 2 weeks after the study treatment (subjects who plan to have local anesthesia surgery can participate in this study);
• have received a live attenuated vaccine within ≤ 4 weeks prior to administration of the pretreatment regimen;
• Presence of severe underlying diseases, such as:
• \- a.Patients with autoimmune diseases (systemic lupus erythem- atosus, multiple sclerosis, rheumatoid arthritis, etc.) who need long-term use of immunosuppressants (methotrexate, cycl - ophosphamide, etc.), biological agents (infliximab, tozumab, etc.), glucocorticoids (prednisone, dexamethasone, etc.);

Sponsors & Collaborators

• The First Affiliated Hospital of Nanchang University: lead
• Cells & Genes Biotech (Shanghai) Co.,Ltd: collaborator

Study Sites (1)

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, 330200, China

RECRUITING

MeSH Terms

Conditions

Recurrence; Multiple Myeloma

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Fei Li

  The First Affiliated Hospital of Nanchang University

  STUDY DIRECTOR

Central Study Contacts

BaoQuan Song

CONTACT

+8615962453016; ndyfy07309@ncu.edu.cn

Lingling Xu

CONTACT

+8613799123760; xulingling@cellsgenes.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2025
• First Posted: May 31, 2025
• Study Start: September 5, 2024
• Primary Completion: April 5, 2026
• Study Completion (Estimated): September 30, 2027
• Last Updated: May 31, 2025

Record last verified: 2025-05

Locations

CN (1)