A Study Evaluating Safety and Efficacy of C-CAR039 Treatment in NHL Subjects

Phase 1

Completed

• Conditions: Non-Hodgkin's B-cell Lymphoma
• Interventions: Biological: Prizloncabtagene Autoleucel

• Registration Number: NCT04317885
• Lead Sponsor: Shanghai Tongji Hospital, Tongji University School of Medicine

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 include the following sequential phases: Screening, Apheresis and C-CAR039 manufacturing, Bridging (if needed), Baseline, lymphodepletion, C-CAR039 infusion, and Follow-up Visit.

Study Timeline

• Study Start: 2019-11-05
• Study First Submitted: 2020-03-20
• Study First Submitted QC: 2020-03-20
• Study First Posted: 2020-03-23
• Primary Completion: 2023-06-30
• Study Completion: 2023-12-30
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-20
• Last Update Posted: 2025-05-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

• 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 Criteria

• 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:

  14. are pregnant/lactating; or

  15. planned pregnancy during the trial; or

  16. 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:

  16. Non-melanoma tumors such as basal cell carcinoma of the skin that are cured by excision

  17. 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Prizloncabtagene Autoleucel	Prizloncabtagene Autoleucel	Prizlon-cel will be intravenously administered as a single infusion after lymphodepletion

Primary Outcome Measures

Name	Time	Method
Incidence and severity of adverse events	Up to 12 weeks after C-CAR039 infusion	Incidence and severity of adverse events after CAR-T infusion

Secondary Outcome Measures

Name	Time	Method
Progression-free survival (PFS)	Up to 24 Months after C-CAR039 infusion	The time from C-CAR039 infusion to the date of progression as assessed by Lugano 2014 criteria or death
Overall survival (OS)	Up to 24 Months after C-CAR039 infusion	The time from C-CAR039 infusion to the date of death
Overall Response rate (ORR)	Up to 24 Months after C-CAR039 infusion	Complete response (CR) rate plus partial response (PR) rate by Lugano 2014 criteria
Duration of response (DOR)	Up to 24 Months after C-CAR039 infusion	The time from the date of first response (PR or CR) to the date of disease progression or death after C-CAR039 infusion

Trial Locations

Locations (1)

Shanghai Tongji Hospital, Tongji University School of Medicine; 🇨🇳 Shanghai, Shanghai, China