Clinical Study on the Safety and Efficacy of CD20/CD19 Cell Injection in the Treatment of Relapsed or Refractory B-cell Non-Hodgkin Lymphoma

NCT07345741 | Not Yet Recruiting

• 1 other identifier: DHZ1962-E
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

Evaluate the safety and tolerability of AcNK-Sup003 cell injection in subjects with relapsed or refractory B-cell non-Hodgkin lymphoma (R/R B-NHL). To preliminarily determine the Maximum Tolerated Dose (MTD) or recommended clinical dose of AcNK-Sup003 cell injection.

Conditions

R/R B-NHL; Relapsed or Refractory B-cell Non-Hodgkin Lymphoma (R/R B-NHL)

Keywords

relapsed or refractory B-cell non-Hodgkin lymphoma (R/R B-NHL)

Outcome Measures

Primary Outcomes (1)

• Overall survival

  Time frame:1, 3,6,12,18, 24 months after treatment

  Time frame:1, 3,6,12,18, 24 months after treatment

Study Arms (1)

Experimental:Experimental group

EXPERIMENTAL

Drug: AcNK-Sup003 cell injection

Interventions

AcNK-Sup003 cell injection DRUG

AcNK-Sup003 cell injection in subjects with relapsed or refractory B-cell non-Hodgkin lymphoma (R/R B-NHL)

Experimental:Experimental group

Eligibility Criteria

• Age: 18 Years - 78 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written informed consent: Signed written informed consent and ability to comply with protocol-specified visits and procedures.
• Age and life expectancy: Age ≥ 18 years with an expected survival of more than 3 months.
• Pathological diagnosis: Histopathologically confirmed CD20+ relapsed or refractory B-cell non-Hodgkin lymphoma (according to WHO 2016 lymphoma classification), including but not limited to:
• Diffuse large B-cell lymphoma (DLBCL) High-grade B-cell lymphoma (HGBCL) Follicular lymphoma grade 3b (3b FL)
• Relapsed or refractory disease: Defined by meeting one or more of the following:
• Relapse, non-response, or progression after hematopoietic stem cell transplantation Stable disease for ≤ 6 months after at least two cycles of second-line therapy (DLBCL/HGBCL/3b FL subtypes must have received CD20-targeted agents and anthracyclines; other subtypes evaluated by investigator for treatment adequacy) Disease progression or relapse after at least second-line therapy (DLBCL/HGBCL/3b FL subtypes must have received CD20-targeted agents and anthracyclines; other subtypes evaluated by investigator for treatment adequacy) ECOG performance status: 0-2.
• Contraception requirements:
• Fertile males and females of childbearing potential must agree to use effective contraception from signing informed consent until 6 months after last study drug administration Negative serum pregnancy test required for females of childbearing potential at screening
• Measurable disease: At least one measurable lesion according to Lugano 2014 criteria:
• Lymph node lesions \> 15mm in longest diameter on CT Extranodal lesions \> 10mm in longest diameter FDG-PET positive (SUV ≥ 4 or 5) Radiated lesions only considered measurable if progression documented after completion of radiotherapy
• Hematological parameters (no blood transfusion or hematopoietic growth factor within 7 days prior to testing):
• Hemoglobin (Hb) ≥ 80 g/L Absolute neutrophil count (ANC) ≥ 1×10⁹/L Platelet count (PLT) ≥ 50×10⁹/L
• Coagulation function:
• International Normalized Ratio (INR) ≤ 1.5×ULN Activated Partial Thromboplastin Time (APTT) ≤ 1.5×ULN (INR 2.0-3.0 acceptable for subjects on prophylactic anticoagulation)
• Organ function requirements:

You may not qualify if:

• Primary CNS involvement: Primary central nervous system lymphoma or active CNS involvement/symptoms.
• Autoimmune conditions: Active autoimmune diseases (e.g., systemic lupus erythematosus, rheumatoid arthritis, multiple sclerosis, Sjögren's syndrome, autoimmune thrombocytopenia) or uncontrolled pleural effusions.
• Cardiovascular history:
• Severe cardiac rhythm/conduction abnormalities requiring intervention QTcF prolongation (\> 450 ms males, \> 470 ms females) Acute coronary syndrome, heart failure, aortic dissection, stroke, or other ≥ grade 3 cardiovascular events within 6 months NYHA class ≥ II heart failure or LVEF \< 50% Uncontrolled hypertension (systolic ≥ 160 mmHg and/or diastolic ≥ 100 mmHg despite medication)
• Prior cell therapies/transplants:
• Autologous stem cell transplant or cell therapy within 3 months Allogeneic stem cell transplant or cell therapy within 6 months History of solid organ transplantation Prior anticancer therapy: Anticancer treatment or participation in other interventional clinical studies within 4 weeks or 5 half-lives (whichever is shorter) before lymphodepletion.
• Recent procedures/vaccinations: Live attenuated vaccine or major surgery within 4 weeks before lymphodepletion, or planned during study.
• Systemic steroids: Requirement for prolonged (≥ 3 days) systemic steroid therapy (≥ 10 mg/day prednisone equivalent) during study (inhaled or topical steroids excluded).
• Other malignancies/conditions: History of other malignancies (except cured in-situ cervical cancer, non-invasive skin cancers, or locally treated prostate/breast carcinoma with ≥ 2 years remission); severe diabetes or other serious comorbidities.
• Active infections: Active fungal, bacterial, viral, or mycobacterial infections requiring systemic treatment within 14 days before lymphodepletion.
• Infectious diseases:
• HBsAg positive or HBcAb positive with detectable HBV DNA HCV antibody positive with detectable HCV RNA HIV antibody positive Active syphilis Hypersensitivity: Life-threatening hypersensitivity or intolerance to study medications or severe allergic diathesis.
• Pregnancy/lactation: Pregnant or breastfeeding females. Other factors: Any condition deemed by investigator to affect compliance or make subject unsuitable for study participation.

Sponsors & Collaborators

• Donghua Zhang: lead

Study Sites (1)

Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology

Wuhan, China

Location

MeSH Terms

Conditions

Recurrence; Lymphoma, B-Cell

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; 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

Andie Fu

CONTACT

15926614832; andie_fu@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: December 24, 2025
• First Posted: January 16, 2026
• Study Start: December 31, 2025
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2030
• Last Updated: January 16, 2026

Record last verified: 2026-01

Locations

CN (1)