C752 for Refractory/Relapsed B Cell Non-Hodgkin Lymphoma

Lymphoma, B-Cell Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06210243
• Other study ID #: PH02001
• Status: Recruiting
• Phase: Phase 1
• Start date: December 24, 2023
• Est. completion date: December 24, 2025

Study information

• Verified date: January 2024
• Source: 920th Hospital of Joint Logistics Support Force of People's Liberation Army of China
• Contact: Sanbin Wang, M.D.
• Phone: +86 13187424131
• Email: sanbin1011[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: December 24, 2025
• Est. primary completion date: December 24, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• CAR-T
• Lymphoma
• Lymphoma, B-Cell
• Lymphoma, Non-Hodgkin

Intervention

Biological:
• C752
C752 will be administered on Day 0

Locations

Country	Name	City	State
China	920th Hospital of Joint LogisticsSupport Force of People's Liberation	Kunming	Yunnan

Sponsors (2)

Lead Sponsor	Collaborator
920th Hospital of Joint Logistics Support Force of People's Liberation Army of China	Shanghai PerHum Therapeutics Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The incidence and severity of adverse events (AEs)		1 year
Primary	Dose Limiting Toxicities		First 28 days s after C752 injection
Secondary	Objective response rate (ORR)	Objective response rate after C752 injection as defined by Lugano 2014	1 year
Secondary	PFS		1 year
Secondary	Pharmacokinetic - AUC		1 year