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

NCT04317885 | Completed Phase 1

• 1 other identifier: 0702-015
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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

Conditions

Non-Hodgkin's B-cell Lymphoma

Outcome Measures

Primary Outcomes (1)

• Incidence and severity of adverse events

  Incidence and severity of adverse events after CAR-T infusion

  Up to 12 weeks after C-CAR039 infusion

Secondary Outcomes (4)

• Overall Response rate (ORR)

  Up to 24 Months after C-CAR039 infusion

• Duration of response (DOR)

  Up to 24 Months after C-CAR039 infusion

• Progression-free survival (PFS)

  Up to 24 Months after C-CAR039 infusion

• Overall survival (OS)

  Up to 24 Months after C-CAR039 infusion

Study Arms (1)

Prizloncabtagene Autoleucel

EXPERIMENTAL

Prizlon-cel will be intravenously administered as a single infusion after lymphodepletion

Biological: Prizloncabtagene Autoleucel

Interventions

Prizloncabtagene Autoleucel BIOLOGICAL

Autologous 2nd generation CD19/CD20-directed CAR-T cells, single infusion intravenously

Also known as: C-CAR039

Prizloncabtagene Autoleucel

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Volunteered to participate in this study and signed informed consent
• \. Age 18-75 years old, male or female
• \. 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.
• \. Relapsed or refractory disease after ≥ 2 lines (for FL, at least 3 lines) of standard therapy or relapsed after autologous stem cell transplantation (ASCT)
• \. At least one measurable lesion (LDi ≥ 1.5 cm);
• \. At least two weeks from last treatment (radiation, chemotherapy, mAb, etc) to apheresis;
• \. LVEF≥ 50% (ECHO)
• \. No active pulmonary infections, normal or mild impaired pulmonary function and SpO2≥92%
• \. Laboratory criteria: ANC≥1.0×109/L; Platelets≥50×109/L; Serum total bilirubin ≤1.5x ULN; Creatinine≤ ULN; AST and ALT≤3x ULN
• \. No contraindications of apheresis;
• \. Expected survival ≥ 3months
• \. ECOG score 0 or 1

You may not qualify if:

• \. Have a history of allergy to cellular products;
• \. According to the NYHA cardiac function grading standards, patients with grade III or IV cardiac dysfunction;
• \. A history of craniocerebral trauma, disturbance of consciousness, epilepsy, cerebrovascular ischemia, cerebrovascular hemorrhagic disease, etc.;
• \. Patients with central nervous system involvement;
• \. Patients with autoimmune diseases, immunodeficiency or other conditions requiring immunosuppressive therapy;
• \. Received allogeneic hematopoietic stem cell transplantation before;
• \. Previous use of any CAR T cell product or other genetically modified T cell therapy;
• \. Autologous stem cell transplantation within 6 weeks before infusion;
• \. 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;
• \. Live vaccination within 4 weeks prior to apheresis;
• \. People infected with HIV, HBV, HCV and TPPA/RPR, and carriers with HBV;
• \. A history of alcohol abuse, drug use or mental illness;
• \. Subjects who are not sterilized and have any of the following conditions:
• are pregnant/lactating; or
• planned pregnancy during the trial; or

Sponsors & Collaborators

• Shanghai Tongji Hospital, Tongji University School of Medicine: lead
• Shanghai AbelZeta Ltd.: collaborator

Study Sites (1)

Shanghai Tongji Hospital, Tongji University School of Medicine

Shanghai, Shanghai Municipality, 200065, China

Location

Related Publications (1)

• Yu W, Li P, Zhou L, Yang M, Ye S, Zhu D, Huang J, Yao X, Zhang Y, Li L, Zhao J, Zhu K, Li J, Zheng C, Lan L, Wan H, Yao Y, Zhang H, Zhou D, Jin J, Liang A. A phase 1 trial of prizloncabtagene autoleucel, a CD19/CD20 CAR T-cell therapy for relapsed/refractory B-cell non-Hodgkin lymphoma. Blood. 2025 Apr 3;145(14):1526-1535. doi: 10.1182/blood.2024026401.

  PMID: 39813680 DERIVED

MeSH Terms

Conditions

Lymphoma, B-Cell

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Aibin Liang, MD, Ph.D

  Shanghai Tongji Hospital, Tongji University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Department of Hematology

Study Record Dates

• First Submitted: March 20, 2020
• First Posted: March 23, 2020
• Study Start: November 5, 2019
• Primary Completion: June 30, 2023
• Study Completion: December 30, 2023
• Last Updated: May 23, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)