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

NCT04696432 | Completed Phase 1

• 1 other identifier: 0702-021
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single-center, open-label study to evaluate the safety and efficacy of C-CAR039 in relapsed and/or refractory B-NHL patients.

Conditions

Non-Hodgkin's B-cell Lymphoma

Keywords

CD19/CD20-directed CAR-T cells

Outcome Measures

Primary Outcomes (1)

• Incidence and severity of adverse events (AE)

  Incidence and severity of adverse events, including AE, Serious AE, AE of special interset (AESI)

  Up to 24 months after C-CAR039 infusion

Secondary Outcomes (8)

• Maximum concentration of C-CAR039 in the peripheral blood (Cmax)

  Up to 24 Months after C-CAR039 infusion

• The last of C-CAR039 in the peripheral blood after infusion (Tlast)

  Up to 24 Months after C-CAR039 infusion

• AUC0-28d of C-CAR039 in the peripheral blood (AUC0-28d)

  Up to 28 days after C-CAR039 infusion

• Time to reach the maximum plasma concentration (Tmax)

  Up to 24 Months after C-CAR039 infusion

• Overall Response rate (ORR)

  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:

• Age 18-70 years (include 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 and bone marrow function.
• The patient volunteered to participate in the study and signed the Informed Consent;

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
• Any situation that the investigator believes will harm the safety of the subjects or interfere with the purpose of the study
• 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 C-CAR039 infusion;
• 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 performed within 2 weeks before enrollment;
• 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 was considered unsuitable for enrollment by the investigator.

Sponsors & Collaborators

• Tianjin Medical University Cancer Institute and Hospital: lead
• Shanghai AbelZeta Ltd.: collaborator

Study Sites (1)

Tianjin Medical University Cancer Institute & Hosipital

Tianjin, Tianjin Municipality, 300060, 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

• Lanfang Li, PhD&MD

  Tianjin Medical University Cancer Institute & Hosipital

  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: SPONSOR

Study Record Dates

• First Submitted: November 30, 2020
• First Posted: January 6, 2021
• Study Start: November 27, 2020
• Primary Completion: July 31, 2023
• Study Completion: December 30, 2023
• Last Updated: May 28, 2025

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)