Safety and Efficacy Study of Anti-PD1 Armored CD19 CAR-T Cells in Adult Subjects With Relapsed or Refractory Diffuse Large B-cell Lymphoma

NCT07368270 | Recruiting Phase 1

• 1 other identifier: TH-RD09-02
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to investigate the safety and tolerability of anti-PD1 armored CD19 CAR-T Cells in adult subjects with relapsed or refractory diffuse large B-cell lymphoma.

Conditions

Diffuse Large B Cell Lymphoma

Outcome Measures

Primary Outcomes (2)

• Incidence of dose-limiting toxicity (DLT)

  Dose-limiting toxicity for each subject

  1 month after injection

• AE/SAE

  Incidence and severity of adverse events (AE), and serious adverse event (SAE)

  1 month, 3 months, 6 months, 12 months after injection

Secondary Outcomes (4)

• Objective response rate (ORR)

  1 month, 3 months, 6 months, 9 months, 12 months after injection

• Overall survival (OS)

  1 month, 3 months, 6 months, 9 months, 12 months after injection

• Duration of response (DOR)

  1 month, 3 months, 6 months, 9 months, 12 months after injection

• Progression-free survival (PFS)

  1 month, 3 months, 6 months, 9 months, 12 months after injection

Study Arms (1)

Anti-PD1 armored CD19 CAR-T cells treatment arm

EXPERIMENTAL

Subjects will be administrated with Anti-PD1 armored CD19 CAR-T cells after lymphocyte depletion by fludarabine and cyclophosphamide.

Biological: Anti-PD1 armored CD19 CAR-T cells

Interventions

Anti-PD1 armored CD19 CAR-T cells BIOLOGICAL

Anti-PD1 armored CD19 CAR-T cells, single intravenous infusion

Anti-PD1 armored CD19 CAR-T cells treatment arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Subjects voluntarily participate in clinical research and sign informed consent.
• \. 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).
• \. Expected survival ≥ 3 months.
• \. At least one measurable lesion as per revised IWG response criteria for malignant lymphom (2014 Lugano criteria).
• \. CD19 positive expression are detected on tumor cells of subjects by flow cytometry or immunohistochemistry.
• \. ECOG score ≤ 2.
• \. 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.
• \. Stable hemodynamics and left ventricular ejection fraction (LVEF) ≥ 45 % assessed by echocardiography or multi-gated radionuclide angiography (MUGA).
• \. 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.

You may not qualify if:

• \. Women who are pregnant or breastfeeding, or planned pregnancy within 6 months.
• \. Infectious disease(HIV, Active Tuberculosis ect.).
• \. Active infection: hepatitis B, hepatitis C.
• \. Abnormal vital signs or refuse to receive examination.
• \. Subjects with psychiatric or psychological disorders are unable to complete treatment or efficacy assessment.
• History of severe hypersensitivity or known hypersensitivity to IL-2.
• \. Systemic or local severe infection requiring antimicrobial therapy.
• \. 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.

Sponsors & Collaborators

• Jiangsu Topcel-KH Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Suzhou Hongci Hematology Hospital

Suzhou, China

RECRUITING

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse

Condition Hierarchy (Ancestors)

Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Central Study Contacts

Xiao Ma

CONTACT

0512-83837999; colleenld2020@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 18, 2026
• First Posted: January 26, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2029
• Last Updated: January 28, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)