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

Non-Hodgkin's B-cell Lymphoma Clinical Trial

Official title:

A Phase 1 Study Evaluating Safety and Efficacy of C-CAR039 Treatment in Subjects With Relapsed and/or Refractory NHL

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04696432
• Other study ID #: 0702-021
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: November 27, 2020
• Est. completion date: December 30, 2023

Study information

• Verified date: May 2023
• Source: Tianjin Medical University Cancer Institute and Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

This is a single-arm, open label, phase I study to evaluate the safety and preliminary efficacy of C-CAR039 in adults with relapsed/refractory B-cell Non-Hodgkin's Lymphoma. 10 patients are planned to be enrolled. Following consent, enrolled subjects will undergo a leukapheresis procedure to collect autologous mononuclear cells for manufacture of C-CAR039. Following manufacture of the drug product, subjects will receive lymphodepleting therapy with fludarabine and cyclophosphamide prior to C-CAR039 infusion. All subjects who have received C-CAR039 infusion will be followed for up to 24 months

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 7
• Est. completion date: December 30, 2023
• Est. primary completion date: July 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

1. Age 18-70 years (include 18 and 70), male or female;

2. Expected survival = 12 weeks

3. ECOG score 0-2

4. CD19 or CD20 positive B-NHL confirmed by cytology or histology according to WHO2016 criteria, including DLBCL, PMBCL, tFL, FL and MCL;

5. Relapsed or refractory disease after = 2 lines (for FL, at least 3 lines) of standard therapy or relapsed after autologous stem cell transplantation (ASCT)

6. 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;

7. No contraindications of apheresis.

8. At least one measurable lesion according to Lugano 2014 criteria;

9. Adequate organ and bone marrow function.

10. The patient volunteered to participate in the study and signed the Informed Consent;

Exclusion Criteria:

1. 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;

2. Active HIV, HBV, HCV or treponema pallidum infection ;

3. Any instability of systemic disease, including but not limited to active infection (except local infection), severe cardiac, liver, kidney, or metabolic disease need therapy;

4. Any uncontrolled active disease that prevents participation in the trial

5. Any situation that the investigator believes will harm the safety of the subjects or interfere with the purpose of the study

6. 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;

7. Active or uncontrolled infections requiring systemic treatment within 14 days before enrollment;

8. Patients who have been previously infected with tuberculosis;

9. Administered Corticosteroids and/or other immunosuppressants within 7 days before apheresis. and 5 days before the infusion of C-CAR039;

10. Patients with central nervous system involvement;

11. Any systemic antitumor therapy performed within 2 weeks before enrollment;

12. 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;

13. Other conditions was considered unsuitable for enrollment by the investigator.

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, B-Cell
• Non-Hodgkin's B-cell Lymphoma

Intervention

Biological:
• Prizloncabtagene autoleucel
Autologous 2nd generation CD19/CD20-directed CAR-T cells, single infusion intravenously

Locations

Country	Name	City	State
China	Tianjin Medical University Cancer Institute & Hosipital	Tianjin	Tianjin

Sponsors (2)

Lead Sponsor	Collaborator
Tianjin Medical University Cancer Institute and Hospital	Cellular Biomedicine Group Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Maximum concentration of C-CAR039 in the peripheral blood (Cmax)	Detect CAR-T copies number by qPCR	Up to 24 Months after C-CAR039 infusion
Secondary	The last of C-CAR039 in the peripheral blood after infusion (Tlast)	Detect CAR-T copies number by qPCR	Up to 24 Months after C-CAR039 infusion
Secondary	AUC0-28d of C-CAR039 in the peripheral blood (AUC0-28d)	Detect CAR-T copies number by qPCR	Up to 28 days after C-CAR039 infusion
Secondary	Time to reach the maximum plasma concentration (Tmax)	Detect CAR-T copies number by qPCR	Up to 24 Months after C-CAR039 infusion
Secondary	Overall Response rate (ORR)	Complete response (CR) rate plus partial response (PR) rate by Lugano 2014 criteria	Up to 24 Months after C-CAR039 infusion
Secondary	Duration of response (DOR)	The time from the date of first response (PR or better) to the date of disease progression or death after C-CAR039 infusion	Up to 24 Months after C-CAR039 infusion
Secondary	Progression-free survival (PFS)	The time from C-CAR039 infusion to the date of progression as assessed by Lugano 2014 criteria or death	Up to 24 Months after C-CAR039 infusion
Secondary	Overall survival (OS)	The time from C-CAR039 infusion to the date of death	Up to 24 Months after C-CAR039 infusion