BridgeMD
Tests treatment safety and results for Non-hodgkin Lymphoma,B Cell
Official title Safety and Efficacy of Metabolically Armed CD19 CAR-T Cells (Meta10-19) in the Treatment of r/r B-NHL Clinical Research
ClinicalTrials.gov ID: NCT06716164
What this study is testing
What is Metabolically Armed CD19 CAR-T cells?
Metabolically Armed CD19 CAR-T cells is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for non-hodgkin lymphoma,b cell.
Also referred to as Meta10-19.
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
- A Study of Metabolically Armed CD19 CAR-T Cells Therapy for Patients With Relapsed and/or Refractory B-cell Non-Hodgkin lymphoma
- 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 19 to 70
You may be able to join if
- All people or guardians must sign an informed consent form approved by the Ethics Committee in person before commencing any screening process;
- Age \> 18 years old, ≤ 70 years old, male or female;
- Diagnosis of relapsed/refractory (R/R) indolent B-cell lymphoma, and/or R/R diffuse large B-cell lymphoma (DLBCL). Refractory diseases are defined as...
- Patients with relapsed or refractory B-cell lymphoma treated with one standard treatment regimen and one salvage regimen treated with rituximab or...
- After treatment with these regimens, patients maintain SD (SD duration ≤ 12 months) or still progress；
You likely can't join if
- Patients with present or history of central nervous system diseases not associated with leukemia or lymphoma， such as seizures disorder...
- Patients who had received chemotherapy other than preconditioning chemotherapy within 2 weeks prior to Meta10-19 infusion;
- Patients who participated in other clinical trials within 30 days prior to enrollment;
- Patients with active hepatitis B (defined as hepatitis B surface antigen positive or hepatitis B core antibody positive, concomitant hepatitis B...
- Patients with HIV antibody positive or treponema pallidum antibody positive;
- Patients with uncontrolled acute life-threatening bacterial, viral or fungal infections (e.g. positive blood cultures ≤72 hours before Meta10-19...
See the full eligibility criteria
Who can join
- All people or guardians must sign an informed consent form approved by the Ethics Committee in person before commencing any screening process;
- Age \> 18 years old, ≤ 70 years old, male or female;
- Diagnosis of relapsed/refractory (R/R) indolent B-cell lymphoma, and/or R/R diffuse large B-cell lymphoma (DLBCL). Refractory diseases are defined as one of the following：
- Patients with relapsed or refractory B-cell lymphoma treated with one standard treatment regimen and one salvage regimen treated with rituximab or another CD20 antibody drug and at least two treatment regiments...
- After treatment with these regimens, patients maintain SD (SD duration ≤ 12 months) or still progress；
- Recurrence after autologous hematopoietic stem cell transplantation, or recurrence of allogeneic HSCT, or inability to accept HSCT for various reasons；
- Patients with double-strike or triple-strike B-cell lymphoma who did not respond to second-line therapy；
- CD19 expression was positive by immunohistochemistry or flow cytometry (accept the results of this peripheral blood mononuclear cells or previous report from a Class A tertiary hospital before peripheral blood...
- If the subject has progressed or relapsed after prior CD19 CAR-T cell therapy, the planned apheresis phase should be at least 1 month after that, or the subject has been treated with other biologics, but is in the...
- At least one measurable lesion at baseline, according to the Preliminary Assessment, staging and Response Assessment recommendations for Hodgkin's and non-Hodgkin's lymphoma (2014 edition);
- Expected survival time greater than 12 weeks;
- ECOG score 0-1 (people with central nervous system diseases caused by leukemia or lymphoma need to be determined by the investigator);
- Organ function：
- Complete blood count (CBC) test [the following criteria should be met within 24 hours prior to apheresis, and supportive treatment such as transfusion, platelet transfusion, cell growth factor (except recombinant...
- Lymphocyte count ≥ 0.5×109/L (except for those receiving bridging chemotherapy);
- Platelet count ≥ 25×109/L;
- Hemoglobin ≥ 70.0 g/L
- Blood Biochemistry:
- Serum creatinine (Scr) ≤ 1.5 x ULN, or
- endogenous creatinine clearance ≥ 40 mL/min (using Cockcroft-Gault formula);
- alanine aminotransferase (ALT) ≤ 2.5 x ULN;
- aspartate aminotransferase (AST) ≤ 2.5 ×ULN;
- Total bilirubin (TBIL) ≤ 2 ×ULN; people with total bilirubin \< 3 × ULN and direct bilirubin \< 1.5× ULN with Gilbert-.Meulengracht syndrome could be included;
- Serum lipase and amylase ≤ 1.5×ULN;
- Alkaline phosphatase (ALP) ≤ 2.5 ×ULN;
- In case of bone or liver metastasis, AST, ALT and ALP ≤ 5 ×ULN;
- Prothrombin time (PT) extended ≤ 4 s, fibrinogen ≥ 1 g/L, activated partial thromboplastin time (APTT) ≤ 1.5 ×ULN;
- Pulmonary function: ≤CTCAE grade 1 dyspnea and oxygen saturation of blood (SaO2) \> 91% in indoor air environment..
- Hemodynamic stability was determined by echocardiography or multichannel radionuclide angiography (MUGA) and LVEF ≥45％;
- Patients using the following drugs must meet the following conditions:
- Steroid: Therapeutic doses of steroids must be discontinued 2 weeks prior to Meta10-19 infusion. However, physiological replacement doses of steroids are permitted, hydrocortisone or its equivalent \< 6-12mg/mm2/ day；
- Immunosuppressive agent: Any immunosuppressive drug must be stopped ≥4 weeks before the informed consent is signed;
- Stop all anti-proliferation therapies other than preconditioning chemotherapy in the 2 weeks before Meta10-19 infusion；
- Treatment for CNS disease must be stopped 1 week before Meta10-19 infusion (e.g., intrathecal methotrexate)
- The patient has recovered from the toxicity of the previous treatment, that is, the CTCAE toxicity grade is less than 1 (The exception is specific toxicity of grade 2 or less, such as hair loss, which the researchers...
- Women of childbearing age and all male patients must consent to use a effective contraception for at least 12 months after Meta10-19 infusion and until two consecutive PCR tests show no more CAR T cells in vivo.
What rules you out
- Patients with present or history of central nervous system diseases not associated with leukemia or lymphoma， such as seizures disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or any...
- Patients who had received chemotherapy other than preconditioning chemotherapy within 2 weeks prior to Meta10-19 infusion;
- Patients who participated in other clinical trials within 30 days prior to enrollment;
- Patients with active hepatitis B (defined as hepatitis B surface antigen positive or hepatitis B core antibody positive, concomitant hepatitis B virus DNA level \> 1000 copies/ml) or hepatitis C (HCV RNA positive);
- Patients with HIV antibody positive or treponema pallidum antibody positive;
- Patients with uncontrolled acute life-threatening bacterial, viral or fungal infections (e.g. positive blood cultures ≤72 hours before Meta10-19 infusion);
- History of unstable angina and/or myocardial infarction within 6 months prior to signing the informed consent; History of uncontrolled thrombotic events, major bleeding, or deep venous thrombosis (DVT) within 12 months...
- Patients with history of other malignancies, but the following conditions can be enrollment:
- Adequately treated basal or squamous cell carcinoma (requiring adequate wound healing before signing informed consent);
- Carcinoma in situ (DCIS) of cervical or breast cancer, which has been treated therapeutically, has shown no signs of recurrence for at least 3 years prior to the signing of the informed consent；
- The primary malignancy has been completely resected and in complete remission for ≥5 years；
- Women who are pregnant or breastfeeding (pregnancy tests for women of childbearing age are positive);
- History of QT interval prolongation or severe cardiac disease;
- Before signing the informed consent form, the ADA (FMC63) test was significantly positive (the test result was weakly positive, and it was necessary to discuss with the investigator whether to rule it out);
- Other conditions that the investigator considered should not be enrolled in this clinical study.
The study team makes the final eligibility decision.
Where it's taking place
- Hangzhou, Zhejiang, 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, 19 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hangzhou, Zhejiang, 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.