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

S

Soochow University

Status

Unknown

Conditions

Lymphoma

Treatments

Diagnostic Test: 68Ga-NOTA-RP25

Study type

Interventional

Funder types

Other

Identifiers

NCT05176275
FirstSoochoowU

Details and patient eligibility

About

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

Full description

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.

Enrollment

10 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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;

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

10 participants in 1 patient group

68Ga-NOTA-RP25
Experimental group
Description:
Intravenous injection
Treatment:
Diagnostic Test: 68Ga-NOTA-RP25

Trial contacts and locations

0

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Central trial contact

Hua Zhang; Yicong Bian

Data sourced from clinicaltrials.gov

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