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Tests treatment safety and results for B-cell Non Hodgkin Lymphoma (NHL)
Official title A Clinical Study Exploring the Safety, Efficacy and Metabolic Kinetics of CT1182 Injection in Patients With Relapsed / Refractory Non Hodgkin Lymphoma
ClinicalTrials.gov ID: NCT07548697
What this study is testing
What is CT1182 injection?
CT1182 injection is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for b-cell non hodgkin lymphoma (nhl).
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 study to evaluate the safety, efficacy, metabolic kinetics and pharmacodynamics of CT1182 cells in patients with relapsed / refractory B-cell non Hodgkin lymphoma (r/r B-NHL).
- 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 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; Willing to follow and be...
- age 18-75 years (inclusive);
- r/r B-NHL diagnosed by histology or cytology includes large B-cell lymphoma, Burkitt lymphoma, mantle cell lymphoma, including diffuse large B-cell...
- have received standardized systemic treatment in the past, including anti-CD20 drugs (except CD20 negative) and anthracyclines;
- intolerance during the last treatment, or the investigator assessed the need for new treatment after the last treatment;
You likely can't join if
- pregnant or lactating women;
- research participants with a history of neurological diseases, such as epilepsy, intracranial hemorrhage, paralysis, aphasia, stroke, severe brain...
- HIV, syphilis infection, active hepatitis B virus infection (HBV-DNA higher than the detection limit or positive), or active hepatitis C virus...
- according to the investigator's judgment, there is currently any uncontrollable active infection, including but not limited to active tuberculosis;
- there is known or suspected long-term active infection of EBV and a known history of HLH;
- have received autologous stem cell transplantation or autologous cell therapy within 3 months before signing the informed consent; Previously...
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; Willing to follow and be able to complete all research procedures;
- age 18-75 years (inclusive);
- r/r B-NHL diagnosed by histology or cytology includes large B-cell lymphoma, Burkitt lymphoma, mantle cell lymphoma, including diffuse large B-cell lymphoma (DLBCL) and high-grade B-cell lymphoma (hgbl) according to the...
- have received standardized systemic treatment in the past, including anti-CD20 drugs (except CD20 negative) and anthracyclines;
- intolerance during the last treatment, or the investigator assessed the need for new treatment after the last treatment;
- meet at least one of the following conditions:
- According to CT measurement: the long diameter of intranodal lesions is \>1.5 cm, or the long diameter of extranodal lesions is \>1.0 cm, and the short diameter can be measured;
- According to PET measurement: FDG uptake score reaches 4 or 5;
- estimated survival \>12 weeks;
- Eastern Cooperative Oncology Group (ECoG) score 0-1;
- participants should meet the following test results (they have not received any granulocyte colony-stimulating factor (G-CSF) / granulocyte macrophage colony-stimulating factor (GM-CSF) treatment and supportive...
- Endogenous creatinine clearance ≥ 50 ml/min (using Cockcroft Gault formula), or creatinine ≤ 1.5 × ULN;
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 × ULN, total bilirubin ≤ 1.5 × ULN; If lymphoma invades the liver: AST and alt ≤ 5 × ULN, total bilirubin ≤ 3.0 × ULN;
- The international normalized ratio (INR) and activated partial thromboplastin time (APTT) should be ≤ 1.5 × ULN.
- Blood oxygen saturation in non oxygen inhalation state ≥ 92%;
- Left ventricular ejection fraction (LVEF) ≥ 50% (LVEF value is near the critical value, and can be enrolled after the investigator has fully assessed the risk);
- female participants with childbearing potential must have a pregnancy test at the time of screening and the result is negative. They are willing to use very effective and reliable methods of contraception within 1 year...
What rules you out
- pregnant or lactating women;
- research participants with a history of neurological diseases, such as epilepsy, intracranial hemorrhage, paralysis, aphasia, stroke, severe brain injury, dementia, Parkinson's disease, cerebellar disease, memory...
- HIV, syphilis infection, active hepatitis B virus infection (HBV-DNA higher than the detection limit or positive), or active hepatitis C virus infection (HCV-RNA positive);
- according to the investigator's judgment, there is currently any uncontrollable active infection, including but not limited to active tuberculosis;
- there is known or suspected long-term active infection of EBV and a known history of HLH;
- have received autologous stem cell transplantation or autologous cell therapy within 3 months before signing the informed consent; Previously received allogeneic stem cell transplantation or allogeneic donor derived...
- have received previous treatment targeting CD19 (unless the CD19 or CD20 target test is still positive);
- previously received pseudotyped viral vector related treatment with vesicular stomatitis virus glycoprotein (VSVG) as envelope protein (including but not limited to VSVG pseudotyped lentivirus, adenovirus or other viral...
- CT1182 has received anti-tumor treatment within 14 days before infusion or within 5 half lives (whichever is shorter), including but not limited to cytotoxic drugs, targeted therapy, radiotherapy, epigenetic therapy or...
- receive systemic glucocorticoids equivalent to \>15 mg/ day prednisone within 7 days before signing the informed consent, except for topical glucocorticoids or physiological replacement therapy;
- have been vaccinated within 4 weeks before signing the informed consent, or it is expected that live attenuated vaccine, inactivated vaccine or RNA vaccine will be vaccinated during the trial or within 12 months after...
- known allergy to ct1182 or any formulation component, allergy or intolerance to tocilizumab, or previous history of other serious allergies such as anaphylactic shock;
- study participants with any of the following cardiac diseases:
- The New York Heart Association (NYHA) cardiac function classification was grade III or IV heart failure;
- Myocardial infarction, unstable angina pectoris, or coronary artery bypass grafting or coronary stent implantation occurred within 6 months before screening;
- There is a history of clinically significant uncontrolled arrhythmias, such as ventricular arrhythmias;
- Other heart diseases that the investigator believes may endanger the safety of study participants due to participation in this study;
- suffering from serious lung disease, and participating in this study may endanger the safety of participants according to the judgment of the investigator;
- the second primary malignant tumor requiring treatment or incomplete remission in the past 3 years, except the following successfully treated tumors with low malignancy such as non metastatic basal cell carcinoma or...
- there is active systemic autoimmune disease, which requires long-term treatment with immunosuppressants;
- 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);
- the investigator assessed that the participants were unable or unwilling to comply with the requirements of the study protocol, or were not suitable to participate in this clinical study for other reasons.
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 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.