Anti‑PD1 armored CD19 CAR‑T therapy for relapsed or refractory diffuse large B‑cell lymphoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, open‑label, single‑arm Phase 1 dose‑escalation study enrolling adults with relapsed or refractory diffuse large B‑cell lymphoma who have CD19‑positive tumors. Participants will receive one of three escalating dose levels of anti‑PD1 armored CD19 CAR‑T cells to identify safety, tolerability, and the maximum tolerated dose, with a predefined maximum total cell dose. Secondary objectives include preliminary measures of efficacy, pharmacokinetics, and cellular persistence of the CAR‑T product. The trial requires measurable disease, ECOG ≤2, adequate organ function, and expected survival of at least three months.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 1\. Subjects voluntarily participate in clinical research and sign informed consent.
* 2\. Adult subjects (age ≥18 ) with relapsed or refractory diffuse large B-cell lymphoma: a) failure to achieve CR after 6 cycles, or PR after 3 cycles, of first-line therapy, or achieve CR after first-line therapy but relapse within 12 months; b) achieve CR after systemic treatment, but are refractory or relapsed, and no plan to transplant, or prepare for transplantation but cannot meet transplantation criteria after second-line therapy; c) not achieve CR after at least two courses of second-line treatment (including autologous stem cell transplantation).
* 3\. Expected survival ≥ 3 months.
* 4\. At least one measurable lesion as per revised IWG response criteria for malignant lymphom (2014 Lugano criteria).
* 5\. CD19 positive expression are detected on tumor cells of subjects by flow cytometry or immunohistochemistry.
* 6\. ECOG score ≤ 2.
* 7\. Subjects with adequate organ functions prior to enrollment, meet the following laboratory values:
* Renal function: serum creatinine ≤ 1.5 × ULN or estimated glomerular filtration rate (eGFR) ≥ 60 mL/min/1.73 m².
* Hepatic function: Serum alanine aminotransferase (ALT) ≤ 5 × age-specific ULN and total bilirubin ≤ 2.0 mg/dL, except in subjects with Gilbert-Meulengracht syndrome. If total bilirubin ≤ 3.0 × ULN and direct bilirubin ≤ 1.5 × ULN, subjects with Gilbert-Meulengracht syndrome are included.
* Pulmonary reserve: ≤ Grade 1 dyspnea and oxygen saturation \>95% on room air.
* 8\. Stable hemodynamics and left ventricular ejection fraction (LVEF) ≥ 45 % assessed by echocardiography or multi-gated radionuclide angiography (MUGA).
* 9\. Adequate bone-marrow reserve without blood transfusion as defined by:
* Absolute neutrophil count (ANC) ≥ 1 x 10\^9/L.
* Absolute lymphocyte count (ALC) ≥ 0.1 x 10\^9/L.
* Platelets ≥ 50 x 10\^9/L.
* Hemoglobin \>80g/L.
* 10\. In the investigator's judgment, subjects' general condition and all biochemical values are either normal or sufficiently compensated to receive lymphodepletion and CAR-T cell therapy.

Exclusion Criteria:

* 1\. Women who are pregnant or breastfeeding, or planned pregnancy within 6 months.
* 2\. Infectious disease(HIV, Active Tuberculosis ect.).
* 3\. Active infection: hepatitis B, hepatitis C.
* 4\. Abnormal vital signs or refuse to receive examination.
* 5\. Subjects with psychiatric or psychological disorders are unable to complete treatment or efficacy assessment.
* 6.History of severe hypersensitivity or known hypersensitivity to IL-2.
* 7\. Systemic or local severe infection requiring antimicrobial therapy.
* 8\. Significant dysfunction of vital organs (heart, lung, brain, kidney, etc.), or in the investigator's judgment, subjects are unable to be enrolled with any other condition.

Where it's running

• Suzhou Hongci Hematology Hospital
  Suzhou, China Recruiting

Study contacts

• Study coordinator: Xiao Ma
• Email: colleenld2020@hotmail.com
• Phone: 0512-83837999

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.