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

RECRUITINGPHASE1

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

A Prospective, Open-label and Single-arm Study of Anti-PD1 Armored CD19 CAR-T Cells in Adult Subjects With Relapsed or Refractory Diffuse Large B-cell Lymphoma

NCT07368270•Jiangsu Topcel-KH Pharmaceutical Co., Ltd.

View on ClinicalTrials.gov

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.

Detailed Description

This is a prospective, open-label, single-arm clinical study to evaluate the safety, tolerability of anti-PD1 armored CD19 CAR-T Cells in adult subjects with relapsed or refractory diffuse large B-cell lymphoma (r/r DLBCL).The study plans to explore across three dose levels (1.00 × 10\^6, 3.00 × 10\^6, 9.00 × 10\^6 CAR+ T cells/kg), and 6.00×10\^8 CAR+T cells as maximum dose, aiming to evaluate the safety, tolerability of anti-PD1 armored CD19 CAR-T Cells in r/r DLBCL, explore Maximum Tolerated Dose (MTD) and determine the recommended dose for Phase II. Besides, efficacy, pharmacokinetics and persistence profile of CAR-T cells are also study objectives.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.
+7 more criteria

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.

Locations (1)

Suzhou Hongci Hematology Hospital

Suzhou, China

Key Dates

Start Date

January 1, 2026

Primary Completion Date

January 1, 2027

Completion Date

January 1, 2029

Last Updated

January 28, 2026

Enrollment

ESTIMATED participants

Conditions

Diffuse Large B Cell Lymphoma

Interventions

Anti-PD1 armored CD19 CAR-T cells

BIOLOGICAL

Contacts

Xiao Ma

CONTACT

0512-83837999 colleenld2020@hotmail.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 28, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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