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Tests treatment safety and results for ALL (Acute B-Lymphoblastic Leukemia)
Official title A Clinical Study Exploring the Safety, Efficacy and Cell Metabolic Kinetics of Universal Car-t Cell Injection in CD19 and / or CD20 Positive Relapsed / Refractory B-cell Acute Lymphoblastic Leukemia in Adolescents, Children and Adults
ClinicalTrials.gov ID: NCT07470073
What this study is testing
What is CT1190B cell injection?
CT1190B cell injection is an investigational medicine, being studied as a potential treatment for all (acute b-lymphoblastic leukemia).
Also referred to as CT1190B.
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 a single arm, open label, dose exploring clinical trial to evaluate the safety, efficacy, cellular metabolic dynamics, and pharmacodynamics of ct1190b cells in relapsed / refractory B-cell acute lymphoblastic leukemia.
- 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 12 to 75
You may be able to join if
- voluntarily participate in clinical research; I fully understand and know this study and sign the informed consent form; ;
- aged 12-75 years (inclusive);
- relapsed / refractory B-ALL diagnosed by morphology, immunology or molecular science, and meeting one of the following conditions:
- The patients who did not achieve complete remission by the standardized induction chemotherapy, or early relapse (\<12 months) after complete...
- For ph+all patients, in addition to receiving standard induction chemotherapy, they should also receive at least two kinds of TKI treatment without...
You likely can't join if
- pregnant or lactating women;
- there is HIV, syphilis infection, active hepatitis B virus infection (HBV-DNA is higher than the detection limit), or active hepatitis C virus...
- there is currently any uncontrollable active infection, including but not limited to patients with active tuberculosis (judged by the investigator);
- there is active systemic autoimmune disease;
- patients with solitary extramedullary lesions;
- research participants with a history of neurological diseases, such as epilepsy, intracranial hemorrhage, severe brain injury, cerebellar disease...
See the full eligibility criteria
Who can join
- voluntarily participate in clinical research; I fully understand and know this study and sign the informed consent form; ;
- aged 12-75 years (inclusive);
- relapsed / refractory B-ALL diagnosed by morphology, immunology or molecular science, and meeting one of the following conditions:
- The patients who did not achieve complete remission by the standardized induction chemotherapy, or early relapse (\<12 months) after complete remission, or late relapse (≥ 12 months) after complete remission, and did...
- For ph+all patients, in addition to receiving standard induction chemotherapy, they should also receive at least two kinds of TKI treatment without complete remission or relapse after complete remission (except those...
- CD19 and / or CD20 positive in bone marrow or peripheral blood;
- the proportion of bone marrow cell morphology or peripheral blood suggestive blasts ≥ 5%;
- estimated survival \>12 weeks;
- study participants should meet the following inspection results (there should be no ongoing continuous supportive care):
- Endogenous creatinine clearance ≥ 30 ml/min (using Cockcroft Gault formula);
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 × ULN, total bilirubin ≤ 1.5 × ULN; In case of hepatobiliary invasion: AST and alt ≤ 5 × ULN, total bilirubin ≤ 3.0 × ULN;
- International normalized ratio (INR) and activated partial thromboplastin time (APTT) ≤ 1.5 × ULN;
- Oxygen saturation in non oxygen inhalation state was \> 91%;
- Left ventricular ejection fraction (LVEF) ≥ 50%.
- Male study participants who had active sex with women with reproductive potential were willing to use very effective and reliable methods of contraception within 1 year after receiving study treatment. All male study...
What rules you out
- pregnant or lactating women;
- there is HIV, syphilis infection, active hepatitis B virus infection (HBV-DNA is higher than the detection limit), or active hepatitis C virus infection (both HCV antibody and HCV-RNA are positive);
- there is currently any uncontrollable active infection, including but not limited to patients with active tuberculosis (judged by the investigator);
- there is active systemic autoimmune disease;
- patients with solitary extramedullary lesions;
- research participants with a history of neurological diseases, such as epilepsy, intracranial hemorrhage, severe brain injury, cerebellar disease, memory impairment, spinal cord compression or any disease involving the...
- patients with bone marrow failure status related genetic syndromes: such as Fanconi anemia, Kostmann syndrome, Shwachman syndrome or any other known bone marrow failure syndrome. Patients with Down syndrome were not...
- for patients who relapsed after treatment with drugs targeting CD19 and / or CD20 before screening, the investigator judged that they could not benefit; 10. have received stem cell transplantation within 12 weeks before...
- received the following treatments before cell infusion:
- Received anthracyclines, vinblastines, 6-mercaptopurine, 6-thioguanine, methotrexate, cytarabine, asparaginase, etc. within 7 days before infusion;
- Hydroxyurea and tyrosine kinase inhibitors were used within 3 days before infusion;
- Radiotherapy was used within 1 week before infusion (2 weeks interval for lung radiotherapy and 8 weeks interval for CNS radiotherapy);
- CNS prophylactic therapy (such as intrathecal injection of chemotherapeutic drugs) within 1 week before infusion;
- Give any T-cell lysis or antibody (such as alemtuzumab) within 8 weeks before infusion;
- Use monoclonal antibody, double antibody or ADC within 4 weeks before infusion;
- Received systemic glucocorticoids equivalent to \>15 mg/ day prednisone within 3 days before infusion, except for glucocorticoids used locally;
- Polyethylene glycol asparaginase was used within 4 weeks before infusion;
- have been vaccinated with live attenuated vaccine, inactivated vaccine or RNA vaccine within 4 weeks before signing the informed consent;
- those who are allergic or intolerant to Qinglin drugs and tocilizumab, or allergic to components (dimethyl sulfoxide /dmso) in ct1190b cell infusion preparations; Or previous history of other serious allergies such as...
- patients with any of the following cardiac diseases before screening:
- New York Heart Association (NYHA) class III or IV heart failure;
- A history of clinically significant uncontrolled arrhythmias, such as ventricular arrhythmias;
- A history of severe non ischemic cardiomyopathy;
- Other heart diseases that the investigator believes may endanger the health of the patient due to participation in this clinical study;
- serious lung disease may endanger the patient's life after participating in the study as judged by the investigator;
- there are second primary malignant tumors that need treatment or have not been completely relieved in the past 2 years, except the following successfully treated tumors with low malignancy such as non metastatic basal...
- major surgery within 2 weeks before signing the informed consent, or major surgery planned during the study or within 4 weeks after giving the study treatment (excluding cataract and other local anesthesia surgery);
- after organ transplantation;
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, 12 years to 75 years. 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.