C752 for Refractory/Relapsed B Cell Non-Hodgkin Lymphoma

February 14, 2025 updated by: 920th Hospital of Joint Logistics Support Force of People's Liberation Army of China

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

2

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Yunnan
      • Kunming, Yunnan, China, 650000
        • 920th Hospital of Joint LogisticsSupport Force of People's Liberation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: C752
Biological: C752
C752 will be administered on Day 0

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The incidence and severity of adverse events (AEs)
Time Frame: 1 year
1 year
Dose Limiting Toxicities
Time Frame: First 28 days s after C752 injection
First 28 days s after C752 injection

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PFS
Time Frame: 1 year
1 year
Objective response rate (ORR)
Time Frame: 1 year
Objective response rate after C752 injection as defined by Lugano 2014
1 year
Pharmacokinetic - AUC
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Collaborators

Shanghai PerHum Therapeutics Co., Ltd.

Investigators

  • Principal Investigator: Sanbin Wang, M.D., 920th Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 24, 2023

Primary Completion (Actual)

December 24, 2024

Study Completion (Actual)

December 24, 2024

Study Registration Dates

First Submitted

January 7, 2024

First Submitted That Met QC Criteria

January 7, 2024

First Posted (Actual)

January 18, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 14, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PH02001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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