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New treatment option for Multiple Myeloma
Official title Study of CT071 Injection in High Risk Newly Diagnosed Multiple Myeloma
ClinicalTrials.gov ID: NCT06407947
What this study is testing
What is Chimeric antigen receptor modified T cells Infusion?
Chimeric antigen receptor modified T cells Infusion is an investigational medicine, being studied as a potential treatment for multiple myeloma.
Also referred to as Single Group Assignment.
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 trial is a single-arm, single-center, open-label clinical trial to evaluate the safety, efficacy, and metabolism kinetics of CT071 in patients with high-risk newly diagnosed 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
- Participants must meet all of the following criteria to be enrolled: 1.Volunteer to participate in the clinical trial; the participants themselves...
- Serum M-protein ≥ 1.0 g/dL;
- Urine M-protein ≥ 200 mg/24 hr;
- Serum free light chain (FLC): involved FLC level ≥ 10 mg/dL (100 mg/L) provided serum FLC ratio is abnormal. 5.Known to have the following high risk...
You likely can't join if
- Participants were not enrolled in the trial if they met any of the following criteria:
- Patients with non-secretory MM.
- Prior treatment for MM other than up to 2 cycles of (bortezomib, lenalidomide, dexamethasone) for induction, including but not limited to cytotoxic...
- Pregnant or lactating females.
- Patients with severe mental disorders or altered mental status, history of central nervous system disease, such as epilepsy, intracranial hemorrhage...
- Participants had other malignancies, including the following that were considered to have been successfully treated: non-metastatic basal cell or...
See the full eligibility criteria
- Participants must meet all of the following criteria to be enrolled: 1.Volunteer to participate in the clinical trial; the participants themselves fully understand and are informed of this study, and sign the informed...
- Serum M-protein ≥ 1.0 g/dL;
- Urine M-protein ≥ 200 mg/24 hr;
- Serum free light chain (FLC): involved FLC level ≥ 10 mg/dL (100 mg/L) provided serum FLC ratio is abnormal. 5.Known to have the following high risk factors, i.e. At least one of the following conditions is met: 1)Meet...
- Participants were not enrolled in the trial if they met any of the following criteria:
- Patients with non-secretory MM.
- Prior treatment for MM other than up to 2 cycles of (bortezomib, lenalidomide, dexamethasone) for induction, including but not limited to cytotoxic therapy, proteasome inhibitors, immunomodulators, targeted therapy...
- Pregnant or lactating females.
- Patients with severe mental disorders or altered mental status, history of central nervous system disease, such as epilepsy, intracranial hemorrhage, paralysis, aphasia, stroke, severe brain injury, dementia...
- Participants had other malignancies, including the following that were considered to have been successfully treated: non-metastatic basal cell or squamous cell skin cancer, non-metastatic prostate cancer, carcinoma in...
- Active autoimmune disease that results in end organ damage or requires systemic immunosuppressive/systemic disease modifying drugs, including but not limited to Crohn's disease, rheumatoid arthritis, systemic lupus...
- Have any uncontrolled active infection (defined as exhibiting persistent signs or symptoms associated with infection that do not improve despite appropriate anti-infective therapy), or other serious active viral...
- Positive test results for biomarkers of any of the following pathogenic microorganisms: human immunodeficiency virus (HIV) antibody, Treponema pallidum antibody (TPPA), hepatitis C virus (HCV) antibody, hepatitis B...
- Vaccination with live attenuated vaccine or mRNA vaccine within 8 weeks and inactivated vaccine within 4 weeks prior to screening.
- Patients who are allergic or intolerant to lymphodpletion drugs, tocilizumab, or allergic to the ingredients of CT071 cell infusion preparation (DMSO); Or previous history of other severe allergies, such as anaphylactic...
- Clinically significant cardiac abnormalities, including but not limited to: 1)Uncontrolled congestive heart failure (New York Heart Association Class III or IV heart failure, see Appendix 3); 2)Myocardial infarction...
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, Shanghai Municipality, 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 Shanghai, Shanghai Municipality, 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.