Actively Recruiting

Phase 1
Age: 18Years - 75Years
All Genders
NCT07456371

PIC1 Injection Therapy for Relapsed/Refractory B-NHL

Led by Chongqing Precision Biotech Co., Ltd · Updated on 2026-03-06

18

Participants Needed

1

Research Sites

152 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This is an investigator-initiated trial aimed at assessing the safety and efficacy of PIC1 injection in the treatment of relapsed/refractory B-cell Non-Hodgkin Lymphoma.

CONDITIONS

Official Title

PIC1 Injection Therapy for Relapsed/Refractory B-NHL

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patient or legally authorized representative has voluntarily agreed to participate and signed informed consent
  • Age between 18 and 75 years, any gender
  • Histologically or cytologically confirmed B-cell Non-Hodgkin Lymphoma according to WHO 2017 classification, including specified subtypes
  • Received prior therapy including anti-CD20 monoclonal antibody and anthracycline unless contraindicated or intolerant
  • Meet definition of relapsed or refractory disease as specified
  • Confirmed CD19 positivity by immunohistochemistry or flow cytometry
  • ECOG performance status of 0 or 1
  • Estimated life expectancy of at least 12 weeks
  • At least one measurable lesion per 2014 Lugano Criteria with specified size
  • Adequate major organ function including cardiac, renal, hepatic, oxygenation, and hematologic parameters
  • Women of childbearing potential must have negative pregnancy test and agree to use effective contraception until one year after infusion
Not Eligible

You will not qualify if you...

  • Prior CAR-T therapy or any gene-modified cell therapy before screening
  • Received anti-tumor therapies or radiation within specified timeframes before infusion, except allowed treatments
  • Cardiac conditions including NYHA Class III or IV heart failure, recent myocardial infarction or bypass surgery, significant arrhythmias, or severe non-ischemic cardiomyopathy
  • Active or uncontrolled infection requiring systemic treatment within one week before screening
  • Grade 2-4 acute graft-versus-host disease or moderate-to-severe chronic graft-versus-host disease within four weeks before screening
  • Recent cerebrovascular accident, seizure, deep vein thrombosis, or arterial embolism within six months before screening
  • History of other malignancies except certain treated cancers with no active disease
  • Received live attenuated vaccine within four weeks before screening
  • Any condition deemed unsuitable for participation by the investigator

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

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, China, 430030

Actively Recruiting

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Research Team

J

Jia Wei

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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PIC1 Injection Therapy for Relapsed/Refractory B-NHL | DecenTrialz