Actively Recruiting
A Study to Evaluate CG-105-12 in Patients With Relapsed/Refractory Multiple Myeloma
Led by The First Affiliated Hospital of Nanchang University · Updated on 2025-05-31
12
Participants Needed
1
Research Sites
160 weeks
Total Duration
On this page
Sponsors
T
The First Affiliated Hospital of Nanchang University
Lead Sponsor
C
Cells & Genes Biotech (Shanghai) Co.,Ltd
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
A Study to Evaluate CG-105-12 in Patients With Relapsed/Refractory Multiple Myeloma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 to 75 years (inclusive), any gender
- Have received at least 3 lines of therapy including proteasome inhibitors and immunomodulatory therapy
- Relapsed, progressive, or refractory multiple myeloma according to IMWG 2016 criteria
- Positive BCMA expression on plasma cells by immunohistochemistry or flow cytometry
- Have not received prior BCMA CAR-T therapy
- Evidence of disease progression by one or more of the specified laboratory or lesion criteria
- ECOG performance status score of 0 to 2
- Expected survival of at least 12 weeks
- Adequate organ function based on specified blood counts, liver, kidney, coagulation, oxygen saturation, and heart function
- Agree to use effective contraception from consent until one year after CAR-T infusion
- Signed informed consent approved by Ethics Committee prior to screening
You will not qualify if you...
- Positive for hepatitis B surface antigen or core antibody with detectable HBV DNA, hepatitis C antibody with RNA, HIV antibody, or syphilis test
- Recent prior antitumor therapies including monoclonal antibodies, CNS radiotherapy, chemotherapy, immunomodulators, proteasome inhibitors, or colony-stimulating factors within specified timeframes before cell collection
- Use of therapeutic corticosteroids (>20 mg/day prednisone or equivalent) within 7 days before screening, except physiologic replacement, topical or inhaled steroids
- Treatment with bendamustine or fludarabine within 12 weeks before screening
- Plasma cell leukemia or suspected CNS involvement
- Previous allogeneic hematopoietic stem cell transplantation
- Malignancies other than multiple myeloma within 5 years except certain treated cancers
- History of solid organ transplantation
- Major surgery within 2 weeks before cell collection or planned within 2 weeks after treatment (except local anesthesia surgery)
- Live attenuated vaccine within 4 weeks before pretreatment
- Severe underlying diseases including autoimmune diseases needing immunosuppressants, uncontrolled infections, uncontrolled diabetes, severe cardiac disease, uncontrolled hypertension, psychiatric or CNS disorders
- Participation in other interventional clinical trials within 1 month before consent
- Pregnant or breastfeeding women or planning pregnancy during trial and 6 months after
- History of severe allergic reactions to drugs or excipients in the protocol
- Other conditions deemed unsuitable by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China, 330200
Actively Recruiting
Research Team
B
BaoQuan Song
CONTACT
L
Lingling Xu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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