PET / CT Imaging and Safety in Patients With Lymphoma Treated With CD19 Car-t Cells

NCT ID: NCT05176275

Last Updated: 2022-01-04

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-01

Study Completion Date

2022-12-01

Brief Summary

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The proliferation and distribution of CD19 CAR-T cells in lymphoma patients are investigated 68Ga-NOTA-RP25 by PET / CT imaging.

Detailed Description

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The purpose of this study is to monitor the proliferation and distribution of CD19 CAR-T cells in lymphoma patients by using a novel specific PET tracer 68Ga-NOTA-RP25 for monitoring the proliferation of CAR-T cells.

Conditions

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Lymphoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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68Ga-NOTA-RP25

Intravenous injection

Group Type EXPERIMENTAL

68Ga-NOTA-RP25

Intervention Type DIAGNOSTIC_TEST

The proliferation and distribution of CD19 CAR-T cells in lymphoma patients were investigated by PET / CT after injection of 68Ga-NOTA-RP25

Interventions

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68Ga-NOTA-RP25

The proliferation and distribution of CD19 CAR-T cells in lymphoma patients were investigated by PET / CT after injection of 68Ga-NOTA-RP25

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* 1\. The subjects voluntarily signed the informed consent form and were able to complete the test according to the protocol requirements; 2. Over 18 years old, male or female; 3. Diagnosed as lymphoma and intended to receive CD19 car-t treatment; 4. ECOG score is 0-1; The estimated survival time shall not be less than 3 months;

Exclusion Criteria

* 1\. Participate in other clinical trials other than CAR-T treatment at the same time or within 28 days. If participating in a non intervention clinical trial, it can be included in this study; 2. Patients with a history of allergy; 3. Patients who cannot tolerant PET / CT imaging; 4. Patients who are using anticoagulant drugs or need to use anticoagulant drugs during the study;
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The First Affiliated Hospital of Soochow University

OTHER

Sponsor Role lead

Responsible Party

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Miao Liyan

Chief Pharmacist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Liyan Miao

Role: PRINCIPAL_INVESTIGATOR

The First Affiliated Hospital of Soochow University

Central Contacts

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Hua Zhang

Role: CONTACT

86 0512 6797 2858

Yicong Bian

Role: CONTACT

86 0512 6797 2858

Other Identifiers

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FirstSoochoowU

Identifier Type: -

Identifier Source: org_study_id

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