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New treatment option for B-Acute Lymphoblastic Leukemia
Official title In VIVO CAR-T Therapy for Relapsed/Refractory Hematological Malignancies
ClinicalTrials.gov ID: NCT07239323
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 b-acute lymphoblastic leukemia.
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 malignant hematological tumors. It is an early exploratory clinical study of the safety, tolerability and initial efficacy in the treatment of relapsed or refractory malignant hematological tumors.
- 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 old, gender unrestricted;
- Confirmed diagnosis of relapsed/refractory malignant hematological tumors, including B-ALL, B-cell lymphoma and multiple myeloma;
- ECOG performance status score 0-2, with an expected survival period of ≥ 3 months;
- Blood routine test results during the screening period meet the following criteria: ① Hemoglobin ≥ 6 g/dL (no red blood cell transfusion within 1...
- Absolute neutrophil count (ANC) ≥ 600/μL (no use of granulocyte colony-stimulating factor [G-CSF] within 1 week before screening, or no use of...
You likely can't join if
- Other anti-tumor treatments within the screening period (judged by the investigator comprehensively): ① Received chemotherapy, targeted therapy or...
- History of hematopoietic stem cell transplantation: Received allogeneic or autologous hematopoietic stem cell transplantation within 3 months before...
- History of other malignant tumors (except for this disease), except for the following situations: ① Received radical treatment and had no known...
- Received treatment related to vesicular stomatitis virus glycoprotein (VSVG) pseudotyped virus in the past;
- Had severe and uncontrolled infections (bacterial, viral, fungal, etc.) within the screening period;
- Clinically significant cardiac diseases:
See the full eligibility criteria
Who can join
- Age ≥ 18 years old, gender unrestricted;
- Confirmed diagnosis of relapsed/refractory malignant hematological tumors, including B-ALL, B-cell lymphoma and multiple myeloma;
- ECOG performance status score 0-2, with an expected survival period of ≥ 3 months;
- Blood routine test results during the screening period meet the following criteria: ① Hemoglobin ≥ 6 g/dL (no red blood cell transfusion within 1 week before screening), recombinant human erythropoietin (rhEPO) is...
- Absolute neutrophil count (ANC) ≥ 600/μL (no use of granulocyte colony-stimulating factor [G-CSF] within 1 week before screening, or no use of pegylated G-CSF within 2 weeks before screening); ③ Platelet count ≥...
- Normal renal function during the screening period: creatinine clearance rate (CrCl) ≥ 45 mL/min (calculated using the Cockcroft-Gault formula);
- Liver function during the screening period meets the following criteria: ① Alanine aminotransferase (ALT), aspartate aminotransferase (AST) ≤ 3.0 × ULN; ② Total bilirubin (TBIL) ≤ 2.0 × ULN (except for congenital...
- Cardiac function during the screening period meets the following criteria: ① Left ventricular ejection fraction (LVEF) ≥ 40% (measured by echocardiography or MUGA scan); ② No clinically significant pericardial effusion...
- Pulmonary function during the screening period meets the following criteria: blood oxygen saturation (SpO₂) ≥ 90%;
- Women of childbearing age must have a negative pregnancy test during the screening period and before drug administration, and must not be in the lactation period;
- Men and women of childbearing age must agree to take effective contraceptive measures and not donate reproductive cells (including sperm or eggs) 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 their understanding of the purpose and procedures of the study and their voluntary participation in this...
What rules you out
- Other anti-tumor treatments within the screening period (judged by the investigator comprehensively): ① Received chemotherapy, targeted therapy or immunotherapy within 5 half-lives before administration; ② Received...
- History of hematopoietic stem cell transplantation: Received allogeneic or autologous hematopoietic stem cell transplantation within 3 months before administration;
- History of other malignant tumors (except for this disease), except for the following situations: ① Received radical treatment and had no known active disease for ≥ 2 years before enrollment; ② Had fully treated...
- Received treatment related to vesicular stomatitis virus glycoprotein (VSVG) pseudotyped virus in the past;
- Had severe and uncontrolled infections (bacterial, viral, fungal, etc.) within the screening period;
- Clinically significant cardiac diseases:
- Had symptomatic heart failure or other serious cardiac diseases (such as severe arrhythmia);
- Had New York Heart Association (NYHA) Class III-IV congestive heart failure; ③ Had a myocardial infarction or received coronary artery bypass grafting (CABG) / coronary artery stent implantation within 6 months before...
- Had clinically significant ventricular arrhythmia or a history of unexplained syncope; ⑤ Had a history of syncope (excluding cases caused by vasovagal reactions or dehydration); ⑥ Had a history of severe non-ischemic...
- Other clinically significant diseases, including but not limited to:
- Primary immunodeficiency; ② Had a stroke or seizure within 6 months before screening;
- Had clear clinical evidence of dementia or mental status changes; ④ Had Parkinson's disease, Parkinson-like movement disorders or a history of the above;
- Had undergone surgery within 2 weeks before administration, or planned to undergo surgery within 2 weeks after administration (local anesthesia surgery excluded);
- Had received live attenuated vaccines within 1 month before administration;
- Had a history of severe allergic reactions to this product or its formulation components;
- Patients who were not suitable for establishing intravenous access;
- The investigator believed that there were other conditions that made the patient unsuitable for participating in this 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.