A Study of EXP039 Treatment in Subjects With r/r NHL Subjects

Non-Hodgkin's B-cell Lymphoma Clinical Trial

Official title:

A Phase 1 Study Evaluating Safety and Efficacy of EXP039 Treatment in Subjects With Relapsed and/or Refractory NHL

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04655677
• Other study ID #: 0702-023
• Status: Recruiting
• Phase: Phase 1
• Start date: August 25, 2020
• Est. completion date: October 2022

Study information

• Verified date: July 2020
• Source: Peking Union Medical College Hospital
• Contact: Daobin Zhou, PhD&MD
• Phone: 010-69155020
• Email: zhoudb[@]pumch.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a single-center, non-randomized study to evaluate the safety and efficacy of EXP039 in relapsed and/or refractory NHL patients.

Description:

The study will include the following sequential phases: Screening, Apheresis, Baseline, Pre-Treatment (Cell Product Preparation, Lymphodepleting Chemotherapy), EXP039 infusion and Follow-up Visit.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: October 2022
• Est. primary completion date: July 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

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

2. Age =18 years old =70 Years old, male or female

3. Expected survival = 12 weeks

4. ECOG score 0-2

5. CD19 or CD20 positive B-NHL confirmed by cytology or histology according to WHO2016 criteria

6. Patients with a clear diagnosis of relapsed and/or refractory B-NHL, including DLBCL, FL and MCL

7. 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

8. No contraindications of apheresis

9. At least one measurable lesion according to Lugano 2014 criteria

10. Adequate organ function and adequate bone marrow reserve

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. 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

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

6. Patients who have been previously infected with tuberculosis

7. Administered Corticosteroids and/or other immunosuppressants within 7 days before apheresis. and 5 days before the infusion of EXP039

8. Patients with central nervous system involvement

9. Any systemic antitumor therapy performed within 2 weeks before enrollment

10. Previous use of any CAR T cell product or other genetically modified T cell therapy

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital	Beijing	Beijing/China

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence of study related adverse events	Incidence and severity of Treatment emergent adverse events	12 Months
Secondary	Maximum concentration (Cmax) of EXP039 in the peripheral blood	Detect CAR-T copies number by qPCR	up to 12 months
Secondary	Time to maximum concentration (Tmax) of EXP039 in the peripheral blood	Detect CAR-T copies number by qPCR	up to 12 months
Secondary	Tlast of EXP039 in the peripheral blood after infusion	Detect CAR-T copies number by qPCR	up to 12 months
Secondary	AUC0h-28d of EXP039 in the peripheral blood	Detect CAR-T copies number by qPCR	4 weeks
Secondary	Objective response rate (ORR)	Complete response (CR) rate plus partial response (PR) rate by Lugano 2014 criteria	4 weeks, 12 weeks, 6 months, 9 months, 12 months
Secondary	Duration of response (DOR)	The time from the date of first response (PR or better) until the date of disease progression after EXP039 infusion	up to 12 months
Secondary	Progression-free survival (PFS)	The time from EXP039 infusion to the date of progression as assessed by Lugano 2014 criteria or death	4 weeks, 12 weeks, 6 months, 9 months, 12 months
Secondary	Overall survival rate (OSR)	The time from EXP039 infusion to the date of death	12 weeks, 6 months, 12 months