C752 for Refractory/Relapsed B Cell Non-Hodgkin Lymphoma
- Registration Number
- NCT06210243
- Lead Sponsor
- 920th Hospital of Joint Logistics Support Force of People's Liberation Army of China
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 2
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description C752 C752 -
- Primary Outcome Measures
Name Time Method Dose Limiting Toxicities First 28 days s after C752 injection The incidence and severity of adverse events (AEs) 1 year
- Secondary Outcome Measures
Name Time Method Objective response rate (ORR) 1 year Objective response rate after C752 injection as defined by Lugano 2014
Pharmacokinetic - AUC 1 year PFS 1 year
Trial Locations
- Locations (1)
920th Hospital of Joint LogisticsSupport Force of People's Liberation
🇨🇳Kunming, Yunnan, China