Status:
COMPLETED
A Study Evaluating Safety and Efficacy of C-CAR039 Treatment in NHL Subjects
Lead Sponsor:
Shanghai Tongji Hospital, Tongji University School of Medicine
Collaborating Sponsors:
Shanghai AbelZeta Ltd.
Conditions:
Non-Hodgkin's B-cell Lymphoma
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief Summary
The trial is a single arm, single-center, non-randomized phase I clinical trial which is designed to evaluate the safety and efficacy of C-CAR039 in treatment of relapsed or refractory NHL patients
Detailed Description
This study plans to enroll 25 patients to assess the safety and efficacy of C-CAR039. Subjects who meet the eligibility criteria will receive a single dose of C-CAR039 injection. The study will inclu...
Eligibility Criteria
Inclusion
- 1\. Volunteered to participate in this study and signed informed consent
- 2\. Age 18-75 years old, male or female
- 3\. CD19 or CD20 positive DLBCL (including PMBCL and tFL), FL and MCL confirmed by cytology or histology according to WHO2016 criteria. For CD20-positive subjects, they should have received at least one regimen containing anti-CD20-targeted therapy (such as rituximab). If they do not complete the regimen due to intolerance, the cause should be recorded.
- 4\. Relapsed or refractory disease after ≥ 2 lines (for FL, at least 3 lines) of standard therapy or relapsed after autologous stem cell transplantation (ASCT)
- 5\. At least one measurable lesion (LDi ≥ 1.5 cm);
- 6\. At least two weeks from last treatment (radiation, chemotherapy, mAb, etc) to apheresis;
- 7\. LVEF≥ 50% (ECHO)
- 8\. No active pulmonary infections, normal or mild impaired pulmonary function and SpO2≥92%
- 9\. Laboratory criteria: ANC≥1.0×109/L; Platelets≥50×109/L; Serum total bilirubin ≤1.5x ULN; Creatinine≤ ULN; AST and ALT≤3x ULN
- 10\. No contraindications of apheresis;
- 11\. Expected survival ≥ 3months
- 12\. ECOG score 0 or 1
Exclusion
- 1\. Have a history of allergy to cellular products;
- 2\. According to the NYHA cardiac function grading standards, patients with grade III or IV cardiac dysfunction;
- 3\. A history of craniocerebral trauma, disturbance of consciousness, epilepsy, cerebrovascular ischemia, cerebrovascular hemorrhagic disease, etc.;
- 4\. Patients with central nervous system involvement;
- 5\. Patients with autoimmune diseases, immunodeficiency or other conditions requiring immunosuppressive therapy;
- 6\. Received allogeneic hematopoietic stem cell transplantation before;
- 7\. Previous use of any CAR T cell product or other genetically modified T cell therapy;
- 8\. Autologous stem cell transplantation within 6 weeks before infusion;
- 9\. Severe active infections (except for simple urinary tract infections, bacterial pharyngitis), or currently undergoing intravenous infusion of antibiotics. However, prophylactic antibiotic, antiviral and antifungal infection treatments are permissible;
- 10\. Live vaccination within 4 weeks prior to apheresis;
- 11\. People infected with HIV, HBV, HCV and TPPA/RPR, and carriers with HBV;
- 12\. A history of alcohol abuse, drug use or mental illness;
- 13\. Subjects who are not sterilized and have any of the following conditions:
- are pregnant/lactating; or
- planned pregnancy during the trial; or
- being fertile and unable to use effective contraception;
- 14\. Severe hypersensitivity to fludarabine or cyclophosphamide;
- 15\. A history of other primary cancers other than the following:
- Non-melanoma tumors such as basal cell carcinoma of the skin that are cured by excision
- Cured in situ cancers such as cervical, bladder, or breast cancer
- 16\. The investigators consider that the subject has other conditions that are not suitable for this trial.
Key Trial Info
Start Date :
November 5 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 30 2023
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT04317885
Start Date
November 5 2019
End Date
December 30 2023
Last Update
May 23 2025
Active Locations (1)
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1
Shanghai Tongji Hospital, Tongji University School of Medicine
Shanghai, Shanghai Municipality, China, 200065