Actively Recruiting

Phase 1
Phase 2
Age: 18Years +
All Genders
NCT06911710

The Application of CAR-T Cell Therapy in Relapsed and Refractory Malignant Hematologic Tumors

Led by Tianjin Medical University General Hospital · Updated on 2025-04-04

90

Participants Needed

1

Research Sites

120 weeks

Total Duration

On this page

Sponsors

T

Tianjin Medical University General Hospital

Lead Sponsor

H

Hebei Taihe Chunyu Biotechnology Co., Ltd

Collaborating Sponsor

AI-Summary

What this Trial Is About

This study is an open, single-arm, prospective, Phase I/II clinical study using "3+3" dose escalation and dose expansion to investigate the safety, maximum tolerated dose, in vivo pharmacokinetic profile, and preliminary efficacy of CAR-T cell injections for the treatment of relapsed/refractory malignant hematological neoplasms in subjects.

CONDITIONS

Official Title

The Application of CAR-T Cell Therapy in Relapsed and Refractory Malignant Hematologic Tumors

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Signed informed consent and willing to comply with study visits, treatments, and procedures
  • Diagnosed with relapsed or refractory malignant hematologic tumors
  • Age 18 years or older, any gender
  • Eastern Cooperative Oncology Group (ECOG) score between 0 and 2
  • Expected survival longer than 3 months
  • Hemoglobin level of at least 60 g/L (transfusions allowed)
  • Liver, kidney, heart, and lung function within specified limits: creatinine ≤1.5 times upper limit of normal, left ventricular ejection fraction ≥50%, blood oxygen saturation >90%, total bilirubin ≤1.5 times upper limit of normal, ALT and AST ≤2.5 times upper limit of normal
  • Agreement to use contraception if pregnancy is planned before and for six months after the study
  • Specific criteria for lymphoma, T-cell lymphoma, acute lymphoblastic leukemia, multiple myeloma, and myeloid tumors cohorts as detailed in the protocol
Not Eligible

You will not qualify if you...

  • Severe heart failure with left ventricular ejection fraction less than 50%
  • Severe lung disease impairing function
  • Progressive other malignant tumors
  • Severe uncontrolled infections
  • Severe autoimmune disease or congenital immune deficiency
  • Active hepatitis B or C infection above detection limits
  • HIV/AIDS or syphilis infection
  • Severe allergy to biological products including antibiotics
  • Ongoing acute graft-versus-host disease one month after stopping immunosuppressants post allogeneic stem cell transplant
  • Other serious physical or mental illnesses or abnormal tests increasing risk or affecting study results as judged by the investigator

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

TianJin China. TianJin Medical University General

Tianjin, Tianjin Municipality, China, 300072

Actively Recruiting

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Research Team

R

Rong Fu

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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