Safety and Efficacy of Metabolically Armed CD19 CAR-T Cells (Meta10-19) in the Treatment of r/r B-NHL Clinical Research

Recruiting now · Early Phase 1

Conditions studied: Non-hodgkin Lymphoma,B Cell

In brief

A Study of Metabolically Armed CD19 CAR-T Cells Therapy for Patients With Relapsed and/or Refractory B-cell Non-Hodgkin lymphoma

Key facts

Study ID

NCT06716164

Run by

Zhejiang University

People needed

36

Starts

2024-12-01

Expected to finish

2027-04-05

Last updated by the study team

2024-12-04

Who can join

Age: 19 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• All subjects 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 appropriate for their disease, one of which should include anthracyclines;
• 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 collection);
• 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 washout period;
• 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 (subjects 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 erythropoietin) should be avoided within 7 days prior to detection]
• 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; Subjects 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;

You may not qualify if…

• 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 autoimmune disease with CNS involvement;
• 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 prior to signing the informed consent;
• 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.

Where it is running

• The first affiliated hospital of medical college of zhejiang university — Hangzhou, Zhejiang, China (enrolling)

Full record on ClinicalTrials.gov

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