A Study of C-CAR039 Treatment in Subjects With r/r NHL Subjects Non-Hodgkin's Lymphoma

NCT04693676 | Unknown Phase 1

• 1 other identifier: 0702-025
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single-arm, open label, dose escalation, phase I study of C-CAR039 in adults with relapsed/refractory B-cell Non-Hodgkin's Lymphoma.

Conditions

Non-Hodgkin's B-cell Lymphoma

Outcome Measures

Primary Outcomes (3)

• MTD

  maximum tolerated dose or clinical recommended dose

  Up to 24 months after C-CAR039 infusion

• DLT

  Dose limiting toxicity

  Up to 28 days after C-CAR039 infusion

• AE/SAE/AESI

  adverse events (AE), serious adverse event (SAE), adverse events of sepical interest (AESI) (including cytokine release syndrome (CRS), and nerve toxicity), laboratory tests (type, frequency and severity), vital signs and ECG abnormality rate.

  Up to 24 months after C-CAR039 infusion

Secondary Outcomes (5)

• C-CAR039 CAR expansion and persistence

  Up to 24 Months after C-CAR039 infusion

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

You may qualify if:

• The patient volunteered to participate in the study and signed the Informed Consent;
• Age between 18 and 70 (including 18 and 70), male or female;
• Expected survival ≥ 12 weeks;
• ECOG score 0-2
• CD19 or CD20 positive B-NHL confirmed by cytology or histology according to WHO2016 criteria, including DLBCL, PMBCL, tFL, FL and MCL;
• Relapsed or refractory disease after ≥ 2 lines (for FL, at least 3 lines) of standard therapy or relapsed after autologous stem cell transplantation (ASCT)
• 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 of intolerance should be recorded;
• No contraindications of apheresis;
• At least one measurable lesion according to Lugano 2014 criteria;
• Adequate organ function.

You may not qualify if:

• Malignant tumors other than B-NHL within 5 years prior to screening, except cervical carcinoma in situ, basal cell or squamous cell skin cancer, local prostate cancer after radical surgery, and breast ductal carcinoma in situ after radical surgery;
• Active HIV, HBV, HCV or treponema pallidum infection ;
• Any instability of systemic disease, including but not limited to active infection (except local infection), severe cardiac, liver, kidney, or metabolic disease need therapy;
• Any uncontrolled, active disease that prevents participation in the trial;
• Female subjects who have been pregnant or breastfeeding, or who plan to conceive during or within 1 year after treatment, or male subjects' partner plans to conceive within 1 year after their cell transfusion;
• Active or uncontrolled infections requiring systemic treatment within 14 days before enrollment;
• Patients who have been previously infected with tuberculosis;
• Administered Corticosteroids and/or other immunosuppressants within 7 days before apheresis. and 5 days before the infusion of C-CAR039;
• Patients with central nervous system involvement;
• Any systemic antitumor therapy was performed within 2 weeks before conditional treatment chemotherapy pretreatment;
• Any situation that the investigator believes would compromise the safety of the subject or interfere with the purpose of the study;
• Those with medical conditions that prevent them from signing the written informed consent or from complying with the study procedures; or those who are unwilling or unable to comply with the study requirements.
• Other conditions deemed unsuitable for enrollment by the investigator.

Sponsors & Collaborators

• First Affiliated Hospital of Zhejiang University: lead
• Shanghai AbelZeta Ltd.: collaborator

Study Sites (1)

The First Affiliated Hospital, College of Medicine, Zhejiang University

Hangzhou, Zhejiang, 310003, 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

• Jie Jin, PhD&MD

  First Affiliated Hospital of Zhejiang University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Masking Details: None (Open Label)
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2020
• First Posted: January 5, 2021
• Study Start: August 3, 2020
• Primary Completion: December 31, 2023
• Study Completion: April 30, 2024
• Last Updated: September 28, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)