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Completed

NCT Number: NCT05454241

CD7 CAR-T for Patients With r/r CD7+ Hematologic Malignancies

This is a open-label, phase 2 study to evaluate the efficacy, safety and PK of CD7 chimeric antigen receptors treatment for patients with refractory/relapsed CD7 positive hematological malignancies.

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Key information

Conditions

Hematological Malignancies Hematologic Diseases Hematologic Neoplasms Hemic and Lymphatic Diseases Neoplasms Neoplasms by Site

Age range

3 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Institute of Hematology & Blood Diseases Hospital

Tianjin, 300020, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosed CD7 positive relapsed/refractory hematological malignancies.
  • Echocardiography shows left ventricular ejection fraction (LVEF) ≥ 50%;
  • There is no active pulmonary infection, and the oxygen saturation during air inhalation is more than 92%;
  • The estimated survival time is more than 3 months;
  • Eastern cooperative oncology group (ECOG) performance status of 0 to 2
  • The patients or their legal guardians voluntarily participated in the trial and signed the informed consent.

Exclusion criteria

  • Patients with history of epilepsy or other central nervous system diseases;
  • Patients with prolonged QT or severe heart disease;
  • Pregnant or lactating women
  • Patients with uncontrolled active infection.
  • Positive for any of the following etiological tests: HIV, HBV, HCV
  • Any other conditions that researcher think it is inappropriate for the subject to anticipate the trial

Treatment and study plan

Anti-CD7 CAR-T

Drug

Universal CAR-T cells targeting CD7

Primary outcomes

  1. Overall Response Rate(ORR)

    Time frame: 1 Year

    Number of patients who achieved response after treatment of CD7 CAR-T cell.

Secondary outcomes

  1. Duration of overall response (DOR)

    Time frame: 1 Year

    Duration of overall response will be assessed from the CAR-T cell infusion to progression, death or last follow-up.

  2. Overall survival(OS)

    Time frame: 1 Year

    OS will be assessed from the CAR-T cell infusion to death or last follow-up.

Sponsors and collaborators

Lead sponsor

Institute of Hematology & Blood Diseases Hospital, China

Other

Registry information

Official study title

Efficacy, Safety and PK of CD7 CAR-T in Patients With Relapsed or Refractory CD7+ Hematological Malignancies

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Jul 12, 2022
Registry last updated
Mar 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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