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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-07

Study Completion Date

2024-08-31

Brief Summary

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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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Detailed Description

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Conditions

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Hematological Malignancies

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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anti-CD7 UCAR-T cells

Group Type EXPERIMENTAL

Anti-CD7 CAR-T

Intervention Type DRUG

Universal CAR-T cells targeting CD7

Interventions

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Anti-CD7 CAR-T

Universal CAR-T cells targeting CD7

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

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

Minimum Eligible Age

3 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No