A Study of C-CAR066 in Subjects With r/r B Cell Lymphoma Who Received CD19 CAR-T Therapy

Overview

The study is a single arm, single-center, non-randomized clinical study which is designed to evaluate the safety and efficacy of C-CAR066 in treatment of r/r B cell lymphoma who received CD19 CAR-T therapy.

Full Title of Study: “A Study Evaluating Safety and Efficacy of CD20 CAR-T(C-CAR066) in Subjects With r/r B Cell Lymphoma Who Received CD19 CAR-T Therapy”

Study Type

• Study Type: Interventional
• Study Design
  • Allocation: N/A
  • Intervention Model: Single Group Assignment
  • Primary Purpose: Treatment
  • Masking: None (Open Label)
• Study Primary Completion Date: May 1, 2021

Detailed Description

This study plans to enroll 12 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), Treatment and Follow-up.

Interventions

• Biological: CD20-directed CAR-T cells
  • Autologous 2nd generation CD20-directed CAR-T cells, single infusion intravenously

Arms, Groups and Cohorts

• Experimental: C-CAR066
  • Autologous C-CAR066 administered by intravenous (IV) infusion

Clinical Trial Outcome Measures

Primary Measures

• Occurrence of study related adverse events
  • Time Frame: 12 weeks
  • Incidence and severity of Treatment emergent adverse events

Secondary Measures

• Overall response rate (ORR)
  • Time Frame: 12weeks, 6months, 12 months
  • Lugano criteria(NHL,2014).
• DOR
  • Time Frame: 12 months
  • Duration of remission
• PFS
  • Time Frame: 12 months
  • Progression free survival
• OS
  • Time Frame: 12weeks, 6months, 12months
  • Overall survival

Participating in This Clinical Trial

Inclusion Criteria

1. Volunteered to participate in this study and signed informed consent 2. Age 14-70 years old, male or female 3. Patients with CD20+ DLBCL(including PMBL and according to the NCCN. non Hodgkin's lymphoma Guidelines(2019 version1.0) , at least one measurable lesion(LDi≥ 1.5 cm); 4. r/r patients who received prior CD19 CAR-T therapy； 5. At least one week from the end of treatment regimen (radiation, chemotherapy, mAb, etc) to apheresis; 6. No immunosuppressive therapy was used within 1 week before infusion, including but not limited to systemic therapy; 7. No mAb treatment within 2 weeks before infusion 8. LVEF≥ 50% (UCG) 9. No active pulmonary infections, normal pulmonary function and SpO2≥92% 10. No contraindications of apheresis; 11. Expected survival ≥ 3months 12. ECOG score 0 or 1 13. The apheresis was received by laboratory and met the requirements for manufacturing CAR-T cell Exclusion Criteria:

1. Have a history of allergy to cellular products 2. Laboratory criteria: Serum total bilirubin ≥2mg/dl, albumin≤35g/L, AST and ALT ≥5 x ULN, Creatinine≥2.0mg/dl, ANC≤750/uL, Platelets≤ 50×10^9/L 3. Have a hereditary syndrome such as Fanconi anemia, Kostmann syndrome, Shwachman syndrome ,etc; 4. According to the NYHA cardiac function grading standards, patients with grade III or IV cardiac dysfunction； 5. A history of QT prolongation 6. Patients with central nervous system involvement 7. Severe active infections (except for simple urinary tract infections, bacterial pharyngitis), or currently undergoing intravenous infusion of antibiotics, or intravenous infusion of antibiotics within 1 week prior to cell infusion. However, prophylactic antibiotic, antiviral and antifungal infection treatments are permissible; 8. People infected with HIV, HBV, HCV and TPPA/RPR, and carriers with HBV; 9. Subjects who are not sterilized have any of the following conditions: 1. are pregnant/lactating; or 2. planned pregnancy during the trial; or 3. being fertile and unable to use effective contraception； 10. The investigators consider that the subject has other conditions that are not suitable for this trial.

Gender Eligibility: All

Minimum Age: 14 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: No

Investigator Details

• Lead Sponsor
  • Shanghai Tongji Hospital, Tongji University School of Medicine
• Collaborator
  • Cellular Biomedicine Group Ltd.
• Provider of Information About this Clinical Study
  • Principal Investigator: Aibin Liang，MD，Ph.D., Director，Department of Hematology – Shanghai Tongji Hospital, Tongji University School of Medicine
• Overall Official(s)
  • Aibin Liang, MD,Ph.D., Principal Investigator, Shanghai Tongji Hospital, Tongji University School of Medicine
• Overall Contact(s)
  • Aibin Liang, MD,Ph.D., 0086-021-66111019, lab7182@tongji.edu.cn