Diffuse Large B Cell Lymphoma
Conditions
Brief summary
This is a single-center, non-randomized and dose-escalation study to evaluate the safety and efficacy of C-CAR066 in treatment of r/r DLBCL who received CD19 CAR-T therapy.
Detailed description
This study plans to enroll 10 patients to assess the safety and efficacy of C-CAR066. Subjects who meet the eligibility criteria will receive a single dose of C-CAR066 injection. The study will include the following sequential phases: Screening, Pre-Treatment (Cell Product Preparation, Lymphodepleting Chemotherapy), C-CAR066 infusion and Follow-up Visit.
Interventions
DRUGC-CAR066
Autologous 2nd generation CD20-directed CAR-T cells, single infusion intravenously
Sponsors
Institute of Hematology & Blood Diseases Hospital, China
Shanghai AbelZeta Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. The patient volunteered to participate in the study, and signed the Informed Consent 2. Age 18-75 years old, male or female 3. Patients diagnosed with diffuse large B-cell lymphoma (DLBCL, De novo or transformed) histologically according to the 2016 WHO Classification, at least one measurable lesion(LDi≥1.5 cm) 4. r/r DLBCL patients who received prior CD19 CAR-T therapy, and positive for CD20 5. At least 2 weeks from last treatment (radiation, chemotherapy, mAb, etc) to apheresis 6. Adequate organ and bone marrow fuction 7. No contraindications of apheresis 8. Expected survival time \> 3 months 9. ECOG scores 0 - 1
Exclusion criteria
1. Have a history of allergy to cellular products 2. Patients with cardiac insufficiency classified as Class III or IV according to the New York Heart Association (NYHA) Heart Function Classification Standard 3. A history of craniocerebral trauma, consciousness disorder, epilepsy, cerebral ischemia or hemorrhagic cerebrovascular disease 4. Patients with active CNS involvement 5. Patients with autoimmune disease, immunodeficiency, or other treatment requiring inhibitors 6. Severe active infection (except simple urinary tract, bacterial pharyngitis), or currently receiving intravenous antibiotics. However, prophylactic antibiotics, antiviral and antifungal treatments are allowed 7. Live vaccination within 4 weeks before peripheral blood apheresis 8. HIV, HBV, HCV and TPPA / RPR infections, and HBV carriers 9. Have a history of alcoholism, drug addiction and mental illness 10. Non-sterile subjects had any of the following: a) being pregnant / lactating; or b) having a pregnancy plan during the trial; or c) having fertility without taking effective contraception 11. Patients with severe fludarabine or cyclophosphamide hypersensitivity 12. The patient has a history of other primary cancers, except for the following: 1. Non-melanoma such as skin basal cell carcinoma cured by resection 2. Cured carcinoma in situ such as cervical, bladder or breast cancer 13. The investigators believe that there are other circumstances that are not suitable for the trial
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The incidence of adverse events | Up to 12 weeks after C-CAR066 infusion | The incidence of treatment-emergent adverse events (TEAEs) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Objective response rate (ORR) | Up to 24 months after C-CAR066 infusion | The percentage of subjects who achieved complete response and partial response |
| Complete response rate (CRR) | Up to 24 months after C-CAR066 infusion | The percentage of subjects who achieved complete response |
| Duration of response (DOR) | Up to 24 months after C-CAR066 infusion | The time from the date of first response (PR or CR) to the date of disease progression or death after C-CAR066 infusion |
| Progression free survival (PFS) | Up to 24 months after C-CAR066 infusion | The time from C-CAR066 infusion to the date of progression as assessed by Lugano 2014 criteria or death |
| Overall survival (OS) | Up to 24 months after C-CAR066 infusion | Time from C-CAR066 infusion to death from any cause |
Countries
China
Contacts
PRINCIPAL_INVESTIGATORDehui Zou
Institute of Hematology & Blood Diseases Hostipal
Outcome results
None listed