Actively Recruiting

Early Phase 1
Age: 18Years - 75Years
All Genders
NCT07548697

A Clinical Study Exploring the Safety, Efficacy and Metabolic Kinetics of CT1182 Injection in Patients With Relapsed / Refractory Non Hodgkin Lymphoma

Led by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Updated on 2026-04-23

24

Participants Needed

1

Research Sites

139 weeks

Total Duration

On this page

Sponsors

U

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

Lead Sponsor

C

CARsgen Life Sciences Co.,Ltd.

Collaborating Sponsor

AI-Summary

What this Trial Is About

This study is a single arm, open label, dose exploring clinical study to evaluate the safety, efficacy, metabolic kinetics and pharmacodynamics of CT1182 cells in patients with relapsed / refractory B-cell non Hodgkin lymphoma (r/r B-NHL).

CONDITIONS

Official Title

A Clinical Study Exploring the Safety, Efficacy and Metabolic Kinetics of CT1182 Injection in Patients With Relapsed / Refractory Non Hodgkin Lymphoma

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Voluntarily agree to participate and sign informed consent
  • Age between 18 and 75 years
  • Diagnosed with relapsed or refractory B-cell non-Hodgkin lymphoma including specific subtypes such as diffuse large B-cell lymphoma, follicular lymphoma grade 3B, mantle cell lymphoma, and others
  • Previously treated with standard therapies including anti-CD20 drugs (unless CD20 negative) and anthracyclines
  • Intolerance to last treatment or need for new treatment as assessed by investigator
  • Meet at least one imaging criteria: intranodal lesion >1.5 cm or extranodal lesion >1.0 cm by CT, or PET scan FDG uptake score 4 or 5
  • Estimated survival greater than 12 weeks
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
  • Laboratory tests within specified limits including kidney and liver function, coagulation, blood oxygen saturation, and heart function
  • Negative pregnancy test for women of childbearing potential and agreement to use effective contraception for 1 year after treatment
Not Eligible

You will not qualify if you...

  • Pregnant or breastfeeding women
  • History of neurological diseases affecting the central nervous system or suspected CNS metastasis
  • Active infections such as HIV, syphilis, active hepatitis B or C
  • Uncontrollable active infections including tuberculosis
  • Known or suspected long-term active Epstein-Barr virus infection or history of hemophagocytic lymphohistiocytosis
  • Recent autologous or allogeneic stem cell transplantation or cell therapy within specified time frames
  • Previous treatment targeting CD19 unless target test remains positive
  • Prior treatment with viral vector therapies involving vesicular stomatitis virus glycoprotein
  • Anti-tumor treatments within 14 days or five half-lives before infusion
  • Use of systemic glucocorticoids above specified doses within 7 days before consent
  • Vaccination within 4 weeks before consent or planned vaccination during study or within 12 months after infusion
  • Allergies to CT1182 or related components
  • Significant cardiac diseases including severe heart failure, recent myocardial infarction, unstable angina, uncontrolled arrhythmias, or other investigator-assessed risks
  • Serious lung disease posing safety risks
  • Second primary malignancy requiring treatment or incomplete remission within 3 years except certain low-risk cancers
  • Active systemic autoimmune diseases requiring long-term immunosuppressants
  • Major surgery within 2 weeks before consent or planned within 4 weeks after treatment
  • Investigator judgement of inability or unwillingness to comply with study requirements or unsuitable for participation

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

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

Wuhan, Hubei, China, 430000

Actively Recruiting

Loading map...

Research Team

H

Heng Mei, M.D., Ph.D

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here