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OncoMatch/Clinical Trials/NCT06120166

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

Is NCT06120166 recruiting? Yes, currently enrolling (May 2026). This Early Phase 1 trial studies Metabolically Armed CD19 CAR-T cells for diffuse large b-cell lymphoma.

Early Phase 1RecruitingHe HuangNCT06120166Data as of May 2026

Treatment: Metabolically Armed CD19 CAR-T cellsA Study of Metabolically Armed CD19 CAR-T Cells Therapy for Patients With Relapsed and/or Refractory Diffuse Large B-Cell Lymphoma

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Extracted eligibility criteria

Cancer type

Diffuse Large B-Cell Lymphoma

Non-Hodgkin Lymphoma

Biomarker criteria

Required: CD19 expression positive

CD19 expression was positive by immunohistochemistry or flow cytometry

Allowed: MYC translocation

Detection of lymphoma cells with C-MYC gene translocation accompanied by BCL-2 gene translocation or/and BCL-6 gene translocation by chromosome or FISH technology

Allowed: BCL2 translocation

Detection of lymphoma cells with C-MYC gene translocation accompanied by BCL-2 gene translocation or/and BCL-6 gene translocation by chromosome or FISH technology

Allowed: BCL6 translocation

Detection of lymphoma cells with C-MYC gene translocation accompanied by BCL-2 gene translocation or/and BCL-6 gene translocation by chromosome or FISH technology

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

Min 2 prior lines

Must have received: anthracycline

A chemotherapy regimen containing anthracyclines

Must have received: chemotherapy for follicular lymphoma — for transformed DLBCL from follicular lymphoma

For patients with transformed DLBCL from follicular lymphoma, they must have previously received chemotherapy for follicular lymphoma and have refractory disease after transformation to DLBCL

Cannot have received: allogeneic hematopoietic stem cell transplantation

Patients with history of allogeneic hematopoietic stem cell transplantation

Lab requirements

Kidney function

Serum creatinine ≤1.5 times ULN, or; The glomerular filtration rate (eGFR) estimated by MDRD formula was ≥60m/ min/1.73m2

Liver function

ALT≤5 times ULN, and; Patients with total bilirubin ≤2.0mg/dl, except those with Gilbert-Meulengracht syndrome. Patients with Gilbert-Meulengracht syndrome with total bilirubin ≤3.0 times ULN and direct bilirubin ≤1.5 times ULN were included

Cardiac function

Hemodynamic stability was determined by echocardiography or multichannel radionuclide angiography (MUGA) and LVEF ≥45%

Organ function: Kidney function is defined as: Serum creatinine ≤1.5 times ULN, or; The glomerular filtration rate (eGFR) estimated by MDRD formula was ≥60m/ min/1.73m2; Liver function is defined as: ALT≤5 times ULN, and; Patients with total bilirubin ≤2.0mg/dl, except those with Gilbert-Meulengracht syndrome. Patients with Gilbert-Meulengracht syndrome with total bilirubin ≤3.0 times ULN and direct bilirubin ≤1.5 times ULN were included; 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%

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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