C752 for Refractory/Relapsed B Cell Non-Hodgkin Lymphoma

NCT ID: NCT06210243

Last Updated: 2025-02-18

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

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

2 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-24

Study Completion Date

2024-12-24

Brief Summary

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It is a single-arm, open-label clinical study to assess the safety and efficacy of the C752 CAR-T Cells for patients with CD19+ refractory/relapsed B cell non-Hodgkin lymphoma.

Detailed Description

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Conditions

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Lymphoma, B-Cell CAR-T

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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C752

Group Type EXPERIMENTAL

C752

Intervention Type BIOLOGICAL

C752 will be administered on Day 0

Interventions

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C752

C752 will be administered on Day 0

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Written informed consent in accordance with federal, local, and institutional guidelines, Males and females ≥18 years of age at the time of consent
* Documented diagnosis of Relapsed/Refractory B-cell Non-Hodgkin Lymphoma
* Have progression by least one systemic treatment and no available standard of care treatment.
* At least one measurable lesion by Lugano 2014
* Expected survival ≥ 12 weeks
* Have an ECOG performance status of 0 or 1
* Adequate organ function
* Screening test indicates histopathological CD19 + if the subject received CD19-targeted therapy
* Women of childbearing age must have a negative pregnancy test, and agree to take effective contraception during the trial

Exclusion Criteria

* Treatment with any prior HSCT, gene therapy product, cell therapy product ect.
* Central nervous system involvement
* HBV/HCV
* HIV infection
* Concurrent use of systemic steroids or immunosuppression
* Uncontrolled active infection
* Wash-out period of from the last anti-cancer treatment
* Active second malignancy
* Have not recovered from the effects of previous therapy
* Have psychological or physical conditions that do not permit compliance with the protocol
* Pregnant or nursing (lactating) women
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai PerHum Therapeutics Co., Ltd.

INDUSTRY

Sponsor Role collaborator

920th Hospital of Joint Logistics Support Force of People's Liberation Army of China

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sanbin Wang, M.D.

Role: PRINCIPAL_INVESTIGATOR

920th Hospital

Locations

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920th Hospital of Joint LogisticsSupport Force of People's Liberation

Kunming, Yunnan, China

Site Status

Countries

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China

Other Identifiers

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PH02001

Identifier Type: -

Identifier Source: org_study_id

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