Clinical Study on the Safety and Efficacy of CD7-Targeted Chimeric Antigen Receptor (CAR) Gene-Modified T Cells for the Treatment of CD7-Positive Hematological Malignancies

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-78
SponsorDonghua Zhang

About this trial

This study is a single-arm, multicenter Investigator-Initiated Trial (IIT) clinical study. The primary objective is to evaluate the safety, pharmacokinetic characteristics, and preliminary efficacy of CAR-T cells in subjects with relapsed/refractory (r/r) CD7-positive hematological malignancies. The study plans to enroll 20 subjects, with the actual sample size to be determined based on real-world occurrence.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients or their guardians understand and voluntarily sign the informed consent form, and are expected to complete the follow-up examinations and treatments required by the study protocol.

Disqualifiers

History of malignancy other than T-cell hematological malignancies within 5 years prior to screening, except for adequately treated cervical carcinoma in situ, basal cell or squamous cell skin cancer, localized prostate cancer after radical treatment, and ductal carcinoma in situ of the breast after radical treatment.

Trial design

Design model

Single group

Treatments tested in this trial

  • CD7-Targeted Chimeric Antigen Receptor (CAR) Gene-Modified T Cells for the Treatment of CD7-Positive Hematological Malignancies

    Drug

    CD7-Targeted Chimeric Antigen Receptor (CAR) Gene-Modified T Cells for the Treatment of CD7-Positive Hematological Malignancies

Treatment groups

28 Participants
are divided into 1 treatment group
Group A: Experimental:Experimental groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Overall survival

Time frame
Time frame:1, 3,6,12,18, 24 months after tretment

Secondary outcomes

Other outcomes

Sponsors and contacts

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Donghua Zhang

Lead sponsor

Tongji Hospital

Sponsor institution

This trial is not recruiting at the moment. You can still explore other options: