A Study of C-CAR039 in Subjects With Relapsed and/or Refractory B Cell Non-Hodgkin's Lymphoma

NCT05149391 | Completed Phase 1

• 1 other identifier: 0702-022
• Study Type: interventional
• Target: 3
• 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 cell Non-Hodgkin's Lymphoma patients.

Conditions

B Cell Non-Hodgkin's Lymphoma

Keywords

CD19/CD20-directed Chimeric Antigen Receptor T Cells

Outcome Measures

Primary Outcomes (1)

• Safety Observation

  Incidence of adverse events after C-CAR039 infusion. Incidence and severity of adverse events according to NCI-CTCAE v5.0 criteria, including Dose Limited Toxicity

  up to 24 Months. Incidence and severity of adverse events after C-CAR039 infusion according to National Cancer Institute Common Terminology Criteria for Adverse Events v5.0 criteria, including dose-limiting toxicity (DLT) and laboratory abnormalities.

Secondary Outcomes (8)

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

  Baseline, Days 4, 7, 10 and weeks 2, 3, 4, 8, 12 and month 6, 9, 12, 15, 18, 21, 24

• Time to maximum concentration (Tmax) of C-CAR039 in the peripheral blood.

  Baseline, Days 4, 7, 10 and weeks 2, 3, 4, 8, 12 and month 6, 9, 12, 15, 18, 21, 24

• Peripheral blood duration of C-CAR039 in the peripheral blood after infusion.

  Baseline, Days 4, 7, 10 and weeks 2, 3, 4, 8, 12 and month 6, 9, 12, 15, 18, 21, 24

• Area under the curve 0h-28d of C-CAR039 in the peripheral blood.

  Baseline, Days 4, 7, 10 and weeks 2, 3, 4

• Overall response rate (ORR)

  4 weeks, 12 weeks, 6 months, 9 months, 12 months, 15 months, 18 months, 21 months, 24 months

Study Arms (1)

C-CAR039

EXPERIMENTAL

Autologous C-CAR039 administered by intravenous (IV) infusion

Biological: CD19/CD20-directed Chimeric Antigen Receptor T Cells

Interventions

CD19/CD20-directed Chimeric Antigen Receptor T Cells BIOLOGICAL

Autologous 2nd generation CD19/CD20-directed Chimeric Antigen Receptor T Cells, single infusion intravenously

Also known as: C-CAR039

C-CAR039

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, 18-70 years (include 18 and 70), male or female;
• Expected survival ≥ 12 weeks
• Eastern Cooperative Oncology Group score 0-2
• CD19 or CD20 positive B-Non-Hodgkin's lymphoma confirmed by cytology or histology according to World Health Organization 2016 criteria;
• Patients with a clear diagnosis of relapsed and/or refractory B-Non-Hodgkin's lymphoma, including Diffuse Large B Cell Lymphoma, Follicular Lymphoma and Mantle Cell Lymphoma. Diffuse Large B Cell Lymphoma includes the following types:
• Diffuse Large B Cell Lymphoma, Non Specifically
• Primary Mediastinal B-cell Lymphoma
• Transformed Follicular Lymphoma
• High Grade B-Cell Lymphoma With MYC and BCL2 and/or BCL6
• High Grade B-Cell Lymphoma, Non Specifically
• 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 and adequate bone marrow reserve

You may not qualify if:

• Malignant tumors other than B-Non-Hodgkin's lymphoma 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;
• Human Immunodeficiency Virus, Hepatitis B Virus, Hepatitis C Virus 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 treatment;
• 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;

Sponsors & Collaborators

• Peking University: lead
• Peking University Cancer Hospital & Institute: collaborator

Study Sites (1)

Peking University Cancer Hospital

Beijing, China

Location

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 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: Professor

Study Record Dates

• First Submitted: November 9, 2021
• First Posted: December 8, 2021
• Study Start: July 20, 2021
• Primary Completion: January 30, 2024
• Study Completion: May 30, 2024
• Last Updated: January 30, 2026

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)