Actively Recruiting

Phase Not Applicable
Age: 14Years - 75Years
All Genders
NCT05618041

The Safety and Efficay Investigation of CAR-T Cell Therapy for Patients With Hematological Malignancies

Led by Hebei Senlang Biotechnology Inc., Ltd. · Updated on 2025-06-24

50

Participants Needed

1

Research Sites

273 weeks

Total Duration

On this page

Sponsors

H

Hebei Senlang Biotechnology Inc., Ltd.

Lead Sponsor

H

Hebei Taihe Chunyu Biotechnology Co., Ltd

Collaborating Sponsor

AI-Summary

What this Trial Is About

To evaluate the tolerability and safety of CAR-T technology in patients with relapsed or refractory hematolymphoid malignancies.

CONDITIONS

Official Title

The Safety and Efficay Investigation of CAR-T Cell Therapy for Patients With Hematological Malignancies

Who Can Participate

Age: 14Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Signed informed consent and willingness to follow study visits, treatment, and tests
  • Diagnosed with relapsed or refractory lymphoma, leukemia, or myeloma
  • Tumor cells express targets for CAR-T therapy confirmed by flow cytometry or immunohistochemical tests
  • Age between 14 and 75 years, any gender
  • Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less
  • Hemoglobin level at least 70g/L (blood transfusions allowed)
  • Adequate liver, kidney, heart, and lung function as defined by specific lab and clinical criteria
  • For T cell tumor patients, peripheral blood tumor cells must meet specific immunophenotype criteria
  • Agreement to use contraception during and for six months after the study if pregnancy is planned
  • Expected survival longer than 3 months
  • Understanding and signing of informed consent form
Not Eligible

You will not qualify if you...

  • Severe heart failure
  • History of severe lung damage
  • Presence of other advanced cancers
  • Severe or uncontrolled infections
  • Severe autoimmune diseases or congenital immune deficiency
  • Active hepatitis B or C infection
  • HIV or syphilis infection
  • History of severe allergic reactions to biological products including antibiotics
  • Hematopoietic stem cell transplant within 6 months prior to allogeneic transplant
  • Previous CAR-T or gene-modified cell therapy before screening
  • Any condition increasing risk or interfering with study outcomes as judged 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

Shanxi Bethune Hospital

Taiyuan, Shanxi, China

Actively Recruiting

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Research Team

W

Weiwei w Tian, MD

CONTACT

N

Na Kuang, MD

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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