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Relapsed/RefractoryEarly Phase 1NCT06999031

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

A Early Phase 1 study testing BCMA-Targeted Chimeric Antigen Receptor Autologous T-cell in people with Relapsed/Refractory and Multiple Myeloma, run by The First Affiliated Hospital of Nanchang University at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Relapsed/Refractory, Multiple Myeloma
What is being tested?
BCMA-Targeted Chimeric Antigen Receptor Autologous T-cell
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
1 siteChina
Study dates
5 Sep 2024to 30 Sep 2027
Phase
Early Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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);
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  • - 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.

Who cannot join

  • 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.
  • 2.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;
  • 3.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;
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  • 4.have received treatment containing bendamustine or fludarabine within 12 weeks prior to screening;
  • 5.Plasma cell leukemia, patients suspected or suspected of having plasma cell tumor central nervous system invasion during screening;
  • 6.patients with previous allogeneic hematopoietic stem cell transplantation;
  • 7.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;
  • 8.subjects with a history of solid organ transplantation;
  • 9.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);
  • 10.have received a live attenuated vaccine within ≤ 4 weeks prior to administration of the pretreatment regimen;
  • 11.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.);
  • - b.Uncontrolled active infection within 7 days prior to collection of a single nuclear cell, and evidence of severe active viral, bacterial infection or uncontrolled systemic fungal infection;
  • - c.Diabetes that cannot be controlled by combination therapy;
  • - d.Severe cardiac disease: including but not limited to unstable angina, myocardial infarction (within 6 months prior to screening), congestive heart failure (NYHA [NYHA] class III or higher), and severe arrhythmia;
  • - e.Patients with hypertension that cannot be controlled by drug therapy, that is, those with hypertension who cannot be reduced to the following range after combined treatment with 2 drugs (systolic blood pressure <160 mmHg, diastolic blood pressure <100 mmHg);
  • - f.Comorbid psychiatric or psychotic disorders or central nervous system disorders;
  • 12.receiving other interventional clinical trial medications within 1 month prior to signing the Informed Consent Form (ICF);
  • 13.Pregnant or breastfeeding women, women/men of chil - dbearing age who have a plan to become pregnant during the trial period and within 6 months after the end of the trial;
  • 14.Patients with a history of severe allergic reaction, or allergic reaction to any drug and related excipient specified in the protocol and judged by the investigator not suitable for enrollment;
  • 15.Other conditions that the investigator considers unsuitable for enrollment.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

BaoQuan Song contact

+8615962453016

ndyfy07309@ncu.edu.cn

Lingling Xu contact

+8613799123760

xulingling@cellsgenes.com

China1 site, 1 recruiting

  • The First Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi, 330200

    BaoQuan Song, +8615962453016, ndyfy07309@ncu.edu.cn

    Lingling Xu, +8613799123760, xulingling@cellsgenes.com

    Recruiting

Other trials in China

About this study

Official title: 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

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.

Read the detailed description

This study is a single-centre, open-label, dose-escalation exploratory clinical trial. Its objective is to evaluate the safety, tolerability, recommended dose, anti-tumor efficacy, and pharmacokinetic characteristics of CG-105-12 infused in participants with BCMA-positive relapsed/refractory multiple myeloma who previously received adequate but uneffective standard treatments.. The study will be carried out in accordance with the protocol. Due to the early-stage of the exploratory clinical research,, the anticipated sample size for the three dose groups is 7-12 participants.

Being tested
BCMA-Targeted Chimeric Antigen Receptor Autologous T-cell
Keywords
multiple myeloma, relapsed/refractory, chimeric antigen receptor T Cell, BCMA
Medical subject headings
Recurrence, Multiple Myeloma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BCMA-Targeted Chimeric Antigen Receptor Autologous T-cellBiological

    Chimeric Antigen Receptor Autologous T-cell

Study groups in NCT06999031
Study groupRoleWhat they receive
Treatment group CG-105-12ExperimentalBiological: BCMA-Targeted Chimeric Antigen Receptor Autologous T-cell
Receives: Biological: BCMA-Targeted Chimeric Antigen Receptor Autologous T-cell

What is being measured

The primary outcome is the main question the study is designed to answer.

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

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

  2. Adverse event related laboratory tests, vital signs, physical examination

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

Secondary outcomes (9)

  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

    Measured: Up to 12 months following CG-105-12 injection

  2. 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

    Measured: Up to 12 months following CG-105-12 injection

  3. Progression free survival (PFS);

    Time from the beginning of treatment with CG-105-12 to the first disease progression or death from any cause

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

  4. Overall survival (OS)

    Time from receiving CG-105-12 treatment(Day0) to death (for any reason)

    Measured: Up to 15 years

  5. Time to remission (TTR)

    Time interval from receiving CG-105-12 treatment（Day 0） to first recording to disease remission

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

  6. Time to complete remission (TTCR):

    The time interval between the subject receiving CG-105-12 treatment（Day 0） and the first recorded complete remission of the disease

    Measured: Up to 12 months following CG-105-12 injection

  7. MRD efficacy evaluation

    Flow MRD evaluation, including MRD negative proportion and MRD negative duration

    Measured: Up to 12 months following CG-105-12 injection

  8. CG-105-12 cell count

    Pharmacokinetic (PK) parameters (including but not limited to Cmax, AUC, Tmax, tlast, etc.) were used to detect the concentration of CG-105-12 cells.

    Measured: Up to 12 months following CG-105-12 injection

  9. The transgenic level of CG-105-12.

    Pharmacokinetic (PK) parameters (including but not limited to Cmax, AUC, Tmax, tlast, etc.) were used to detect the transgenic level of CG-105-12.

    Measured: Up to 12 months following CG-105-12 injection

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 May 2025
  2. Study start5 Sep 2024
  3. Primary completion5 Apr 2026 (estimated)
  4. Study completion30 Sep 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
12 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06999031
Sponsor's protocol ID
CG-105-12
Status last verified
May 2025
First submitted
15 May 2025
Last updated
31 May 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing BCMA-Targeted Chimeric Antigen Receptor Autologous T-cell in people with Relapsed/Refractory and Multiple Myeloma, run by The First Affiliated Hospital of Nanchang University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 21 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 31 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact BaoQuan Song (+8615962453016, ndyfy07309@ncu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The incidence of dose-limiting toxicity (DLT). (time frame: Day 0~ 28 after treatment with CG-105-12 injection（D0）). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06999031.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2025.

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