CAR-T, Lymphoma, B-Cell
Conditions
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.
Interventions
BIOLOGICALC752
C752 will be administered on Day 0
Sponsors
Shanghai PerHum Therapeutics Co., Ltd.
920th Hospital of Joint Logistics Support Force of People's Liberation Army of China
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence and severity of adverse events (AEs) | 1 year |
| Dose Limiting Toxicities | First 28 days s after C752 injection |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Objective response rate (ORR) | 1 year | Objective response rate after C752 injection as defined by Lugano 2014 |
| PFS | 1 year | — |
| Pharmacokinetic - AUC | 1 year | — |
Countries
China
Outcome results
None listed