Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT07211048

Anti CD19 Gene Therapy for B-cell Lymphoma

Led by Anhui Provincial Hospital · Updated on 2026-01-21

18

Participants Needed

1

Research Sites

197 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This is an open label, single-site, dose-escalation study in up to 18 participants with treatment of relapsed/refractory B-cell lymphoma. This study aims to evaluate the safety and efficacy of the treatment with an Anti- CD19 gene injection

CONDITIONS

Official Title

Anti CD19 Gene Therapy for B-cell Lymphoma

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older, any gender
  • Diagnosed with specified types of B-cell lymphoma, including diffuse large B-cell lymphoma, primary cutaneous DLBCL, primary mediastinal large B-cell lymphoma, ALK-positive anaplastic large B-cell lymphoma, high-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements, T-cell-rich B-cell lymphoma, transformed follicular lymphoma, follicular lymphoma, mantle cell lymphoma, or large cell transformation of CLL
  • Previously received at least second-line standard treatment and did not achieve remission or relapsed after remission
  • At least one measurable lesion at baseline by PET-CT or CT imaging (lymph node lesion >15 mm or extranodal lesion >10 mm)
  • Tumor cells confirmed CD19 positive by immunohistochemistry
  • Adequate vital organ function: liver function ALT ≤3×ULN, AST ≤3×ULN; serum creatinine ≤140 μmol/L; total bilirubin ≤2×ULN or ≤3×ULN in patients with Gilbert's syndrome; stable heart function with LVEF ≥45%; no active pulmonary infection and oxygen saturation ≥92% without supplemental oxygen
  • ECOG performance status 0-2
  • Expected survival of more than 3 months
  • Agreement to use reliable contraception from signing consent until 2 years after LCAR02 infusion for participants of childbearing potential
Not Eligible

You will not qualify if you...

  • History of central nervous system diseases or pathological changes within 6 months before screening, including stroke, cerebrovascular accident, aneurysm, epilepsy, convulsions, aphasia, severe traumatic brain injury, dementia, Parkinson's disease, cerebellar diseases, organic brain syndrome, or mental disorders
  • Malignant tumors other than B-cell lymphoma
  • Received vaccines or B-cell targeted therapy within 4 weeks before screening
  • Systemic autoimmune diseases or immunodeficiency
  • Grade 2-4 acute graft-versus-host disease or moderate to severe chronic GVHD within 4 weeks before screening
  • Severe heart disease such as angina, myocardial infarction, heart failure, or arrhythmia
  • History of severe allergies to study drugs or excipients
  • Active hepatitis B, HCV antibody positivity, HIV antibody positivity, or positive for syphilis
  • Active infections requiring intravenous antibiotics or hospitalization
  • Pregnant or breastfeeding women

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Anhui Provincial Hospital

Hefei, Anhui, China, 230001

Actively Recruiting

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Research Team

W

wang xing bing, M.D

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

1

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