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Tests treatment safety and results for Multiple Myeloma (MM)
Official title A Clinical Study to Evaluate the Safety and Preliminary Efficacy of QI-019A in Patients With Relapsed/Refractory Multiple Myeloma.
ClinicalTrials.gov ID: NCT07429721
What this study is testing
What is QI-019A Injection?
QI-019A Injection is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for multiple myeloma (mm).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a single-arm, open-label, single-center clinical trial to evaluate the safety, tolerability, efficacy, pharmacokinetics, and pharmacodynamics of QI-019A in patients with relapsed/refractory multiple myeloma.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 1\. Age ≥ 18 years, any gender;
- 2\. Diagnosed with multiple myeloma (MM) according to IMWG diagnostic criteria;
- 3\. Have received at least 2 lines of anti-MM treatment, with at least one full treatment cycle per line, and experienced disease progression during...
- 4\. Disease must be measurable at screening, meeting one or more of the following criteria:
- Serum M protein level ≥ 0.5 g/dL;
You likely can't join if
- 1.During screening, participants who have received other anticancer treatments (based mainly on investigator judgment):
- Received targeted therapy, epigenetic therapy, other investigational drugs, or treatment using invasive research medical devices within 5 half-lives;
- Received immune/non-immune-directed systemic therapy within 1 week;
- Received cytotoxic therapy within 2 weeks;
- Received proteasome inhibitors within 2 weeks;
- Received immunomodulatory therapy within 1 week.
See the full eligibility criteria
Who can join
- 1\. Age ≥ 18 years, any gender;
- 2\. Diagnosed with multiple myeloma (MM) according to IMWG diagnostic criteria;
- 3\. Have received at least 2 lines of anti-MM treatment, with at least one full treatment cycle per line, and experienced disease progression during the most recent anti-myeloma treatment or within 12 months after it...
- 4\. Disease must be measurable at screening, meeting one or more of the following criteria:
- Serum M protein level ≥ 0.5 g/dL;
- Or urine M protein level ≥ 200 mg/24h;
- Or involved serum free light chain ≥ 10 mg/dL with abnormal serum free light chain κ/λ ratio;
- 5\. ECOG performance status 0-2, with an expected survival of ≥ 3 months;
- 6\. Bone marrow function test results (from screening or within 2 months prior) meet the following requirements:
- Hemoglobin ≥ 6 g/dL (no red blood cell transfusion within 1 week before screening), recombinant human erythropoietin allowed; for patients meeting the ≥ 6 g/dL hemoglobin requirement at screening, red blood cell...
- Absolute neutrophil count (ANC) ≥ 600/μL (no use of granulocyte colony-stimulating factor (G-CSF) within 1 week before screening or pegylated G-CSF within 2 weeks before screening);
- Platelet count ≥ 50,000/μL;
- Lymphocyte count ≥ 500/μL;
- 7\. Normal renal function: Creatinine clearance (CrCl) (Cockcroft-Gault formula) ≥45 mL/min;
- 8\. Liver function must meet the following criteria:
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3.0× the upper limit of normal (ULN);
- Total bilirubin (TBIL) and alkaline phosphatase (AKP or ALP) ≤2.0× ULN (except for congenital hyperbilirubinemia, e.g., Gilbert's syndrome, direct bilirubin ≤1.5× ULN);
- Albumin ≥3 g/dL;
- 9\. Cardiac function must meet the following criteria:
- Left ventricular ejection fraction ≥50% (by echocardiography or MUGA scan);
- No clinically significant pericardial effusion;
- No clinically significant electrocardiogram abnormalities;
- 10\. Pulmonary function must meet the following criteria:
- Blood oxygen saturation ≥90% without oxygen supplementation;
- 11\. Women of childbearing potential must have a negative pregnancy test at screening and before drug infusion and must not be breastfeeding.
- 12\. Men and women of childbearing potential must agree to use effective contraception from the time of signing the informed consent until 1 year after the use of the study drug;
- 13\. Men and women of childbearing potential must agree not to donate sperm or eggs (oocytes) or other reproductive cells from the time of signing the informed consent until 1 year after the use of the study drug;
- 14\. The subject or their legal guardian agrees to participate in this clinical trial and signs the informed consent form (ICF), indicating that they understand the purpose and procedures of this clinical trial and are...
What rules you out
- 1.During screening, participants who have received other anticancer treatments (based mainly on investigator judgment):
- Received targeted therapy, epigenetic therapy, other investigational drugs, or treatment using invasive research medical devices within 5 half-lives;
- Received immune/non-immune-directed systemic therapy within 1 week;
- Received cytotoxic therapy within 2 weeks;
- Received proteasome inhibitors within 2 weeks;
- Received immunomodulatory therapy within 1 week.
- Received radiotherapy within 4 weeks (if the radiotherapy covered ≤5% of bone marrow reserve, the subject is eligible regardless of the radiotherapy end date);
- 2\. Received allogeneic hematopoietic stem cell transplantation within 6 months or autologous hematopoietic stem cell transplantation within 3 months before infusion;
- 3\. Had malignancies other than MM before screening, except for: malignancies treated with curative intent, with no known active disease ≥2 years prior to enrollment; or adequately treated non-melanoma skin cancer with...
- 4\. Received any treatment using vesicular stomatitis virus G (VSVG) pseudotyped virus;
- 5\. Had severe, uncontrolled infection symptoms (bacterial, viral, fungal, etc.) during the screening period;
- 6\. Within 6 months before infusion, tested positive for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) with peripheral blood HBV DNA levels above the normal range; tested positive for...
- 7\. Had symptomatic heart failure or other serious cardiac diseases such as severe arrhythmias:
- New York Heart Association (NYHA) class III or IV congestive heart failure;
- Experienced myocardial infarction or underwent coronary artery bypass graft (CABG) or coronary stent implantation within 6 months prior to signing the ICF;
- Had clinically significant ventricular arrhythmias, or a history of unexplained syncope (excluding cases caused by vasovagal response or dehydration);
- Had a history of severe non-ischemic cardiomyopathy;
- 8\. Other clinically significant diseases, including:
- Primary immunodeficiency;
- Stroke or seizure within 6 months prior to screening;
- Clear clinical evidence of dementia or altered mental status;
- Parkinson's disease or Parkinsonian movement disorders or history thereof;
- 9\. Undergoing surgery within 2 weeks of administration or planned surgery within 2 weeks after administration, except for surgeries under local anesthesia;
- 10\. Administration of live attenuated vaccines within 1 month before dosing;
- 11\. Known severe allergic reaction to QI-019B or any of its formulation components;
- 12\. Known severe allergic reaction to tocilizumab;
- 13\. Unsuitable for establishing intravenous access;
- 14\. Other conditions deemed by the investigator to be unsuitable for participation in this study.
The study team makes the final eligibility decision.
Where it's taking place
- Wuhan, Hubei, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Wuhan, Hubei, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.