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New treatment option for Relapsed or Refractory Multiple Myeloma (RRMM)
Official title In Vivo PICX CAR-T Therapy for R/R Multiple Myeloma
ClinicalTrials.gov ID: NCT07715630
What this study is testing
What is Invivo CAR-T?
Invivo CAR-T is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for relapsed or refractory multiple myeloma (rrmm).
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 study is an investigator-initiated, single-center, single-arm clinical study with a target population of patients with relapsed or refractory multiple myeloma. It is an early exploratory clinical study evaluating the safety, tolerability, and preliminary efficacy of PICX Injection, an in vivo prepared CAR-T cell therapy, in the treatment of relapsed or refractory multiple myeloma.
- Phase 1: an early, usually small safety study
- Time commitment: about 2 years
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
- Age ≥ 18 years, male or female;
- Confirmed diagnosis of multiple myeloma meeting at least one of the following criteria:
- Disease progression after at least 2 prior standard treatment regimens; or poor response to primary therapeutic agents (e.g., immunomodulatory...
- Disease progression within 18 months after first-line therapy
- Presence of features associated with high risk of disease relapse or progression (e.g., high-risk cytogenetic abnormalities);
You likely can't join if
- Prior treatment with CAR-T therapy or other gene-modified cell therapy before screening;
- Presence of active central nervous system (CNS) involvement at screening (including brain parenchymal, meningeal, or spinal meningeal involvement, or...
- Received the following anti-tumor therapies prior to PICX Injection infusion:
- Chemotherapy, combination therapy with proteasome inhibitors and immunomodulatory agents, or other systemic anti-tumor drug therapy within 14 days or...
- Radiotherapy to non-hematopoietic sites within 7 days, or to hematopoietic sites within 14 days before infusion;
- BCMA-targeting antibody-based therapy within 3 months before infusion;
See the full eligibility criteria
Who can join
- Age ≥ 18 years, male or female;
- Confirmed diagnosis of multiple myeloma meeting at least one of the following criteria:
- Disease progression after at least 2 prior standard treatment regimens; or poor response to primary therapeutic agents (e.g., immunomodulatory agents, proteasome inhibitors)
- Disease progression within 18 months after first-line therapy
- Presence of features associated with high risk of disease relapse or progression (e.g., high-risk cytogenetic abnormalities);
- At least one measurable disease indicator:
- Serum M-protein ≥ 0.5 g/dL
- Urine M-protein ≥ 200 mg/24 hours
- Involved serum free light chain (sFLC) ≥ 10 mg/dL with an abnormal serum free light chain κ/λ ratio
- No evidence of extramedullary plasmacytoma (soft tissue plasmacytoma);
- ECOG performance status score 0-2;
- Expected survival period ≥ 3 months;
- Adequate bone marrow function within 1 month prior to screening:
- Hemoglobin ≥ 60 g/L;
- Absolute neutrophil count (ANC) ≥ 0.5 × 10⁹/L;
- Platelet count (PLT) ≥ 50 × 10⁹/L;
- Lymphocyte count ≥ 0.5 × 10⁹/L;
- CD3-positive T-cell absolute count ≥ 0.15 × 10⁹/L;
- Adequate vital organ function within 1 month prior to screening:
- Renal function: creatinine clearance rate (CrCl) ≥ 30 mL/min (calculated using the Cockcroft-Gault formula), or serum creatinine (Scr) ≤ 2.0 × upper limit of normal (ULN);
- Hepatic function: alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3.0 × ULN; total bilirubin (TBIL) ≤ 2.0 × ULN (except for patients with congenital hyperbilirubinemia such as Gilbert's syndrome...
- Cardiac function: left ventricular ejection fraction (LVEF) ≥ 40%; no clinically significant pericardial effusion; and no clinically significant electrocardiogram (ECG) abnormalities (e.g., severe arrhythmia, myocardial...
- Pulmonary function: blood oxygen saturation (SpO₂) ≥ 90% without supplemental oxygen;
- Women of childbearing potential must have a negative pregnancy test during the screening period and before study drug administration, and must not be lactating during the study;
- Men and women of childbearing potential must agree to use effective contraceptive measures (excluding unreliable methods such as rhythm method) from the time of signing the informed consent form until 1 year after the...
- The subject or their legally authorized representative has signed the informed consent form (ICF), indicating understanding of the study purpose and procedures and voluntary participation.
What rules you out
- Prior treatment with CAR-T therapy or other gene-modified cell therapy before screening;
- Presence of active central nervous system (CNS) involvement at screening (including brain parenchymal, meningeal, or spinal meningeal involvement, or positive cerebrospinal fluid for tumor cells), or other CNS diseases;
- Received the following anti-tumor therapies prior to PICX Injection infusion:
- Chemotherapy, combination therapy with proteasome inhibitors and immunomodulatory agents, or other systemic anti-tumor drug therapy within 14 days or at least 5 half-lives before infusion (excluding intrathecal...
- Radiotherapy to non-hematopoietic sites within 7 days, or to hematopoietic sites within 14 days before infusion;
- BCMA-targeting antibody-based therapy within 3 months before infusion;
- Active or uncontrolled infection requiring systemic treatment at screening (including bacterial, viral, fungal, or other infections);
- Presence of any of the following cardiac conditions:
- New York Heart Association (NYHA) Class III or IV congestive heart failure;
- Myocardial infarction, or coronary artery bypass grafting (CABG), or coronary stent placement within 6 months prior to screening;
- Clinically significant ventricular arrhythmia, or history of syncope of unknown cause (excluding vasovagal or dehydration-related);
- History of severe non-ischemic cardiomyopathy;
- Presence of other clinically significant diseases or conditions, including:
- Primary immunodeficiency disease;
- Cerebrovascular accident or seizure within 6 months prior to screening;
- Definite cognitive impairment or psychiatric/behavioral abnormalities (e.g., dementia, altered mental status), or severe psychiatric disorders;
- Parkinson's disease, Parkinsonism, or other movement disorders;
- Grade 2-4 acute graft-versus-host disease (GVHD) or moderate to severe chronic GVHD within 4 weeks prior to screening;
- History of other malignancies other than multiple myeloma prior to screening, except for:
- Malignancies treated with curative intent with no known active disease for ≥ 2 years prior to enrollment;
- Adequately treated cervical carcinoma in situ, basal cell or squamous cell skin carcinoma, localized prostate cancer after radical surgery, or ductal carcinoma in situ after radical surgery;
- Vaccination with live-attenuated vaccine within 4 weeks prior to screening;
- Known severe hypersensitivity to PICX Injection or any of its formulation components;
- Inability to establish venous access;
- Other conditions deemed by the investigator to be unsuitable for participation in the study.
The study team makes the final eligibility decision.
Where it's taking place
- Kunming, Yunnan, 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 study runs about 2 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you 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 Kunming, Yunnan, 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.