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

• Sponsor: Peking Union Medical College Hospital (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04655677
• Collaborator: (none)
• Enrollment: 10
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 25.2
• Patients Per Site Per Month: 0.4

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Non-Hodgkin's B-cell Lymphoma	Biological: CD19/CD20-directed CAR-T cells	Phase 1

Detailed 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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 10 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase 1 Study Evaluating Safety and Efficacy of EXP039 Treatment in Subjects With Relapsed and/or Refractory NHL
• Actual Study Start Date: Aug 25, 2020
• Anticipated Primary Completion Date: Jul 1, 2022
• Anticipated Study Completion Date: Oct 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Autologous EXP039 administered by intravenous (IV) infusion Autologous EXP039 administered by intravenous (IV) infusion	Biological: CD19/CD20-directed CAR-T cells; Autologous 2nd generation CD19/CD20-directed CAR-T cells, single infusion intravenously; Other Names: EXP039

Outcome Measures

Primary Outcome Measures

1. Occurrence of study related adverse events [12 Months]

   Incidence and severity of Treatment emergent adverse events

Secondary Outcome Measures

1. Maximum concentration (Cmax) of EXP039 in the peripheral blood [up to 12 months]

   Detect CAR-T copies number by qPCR

2. Time to maximum concentration (Tmax) of EXP039 in the peripheral blood [up to 12 months]

   Detect CAR-T copies number by qPCR

3. Tlast of EXP039 in the peripheral blood after infusion [up to 12 months]

   Detect CAR-T copies number by qPCR

4. AUC0h-28d of EXP039 in the peripheral blood [4 weeks]

   Detect CAR-T copies number by qPCR

5. Objective response rate (ORR) [4 weeks, 12 weeks, 6 months, 9 months, 12 months]

   Complete response (CR) rate plus partial response (PR) rate by Lugano 2014 criteria

6. Duration of response (DOR) [up to 12 months]

   The time from the date of first response (PR or better) until the date of disease progression after EXP039 infusion

7. Progression-free survival (PFS) [4 weeks, 12 weeks, 6 months, 9 months, 12 months]

   The time from EXP039 infusion to the date of progression as assessed by Lugano 2014 criteria or death

8. Overall survival rate (OSR) [12 weeks, 6 months, 12 months]

   The time from EXP039 infusion to the date of death

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Peking Union Medical College Hospital	Beijing	Beijing/China	China	100000

Sponsors and Collaborators

• Peking Union Medical College Hospital

Investigators

• Principal Investigator: Daobin Zhou, PhD&MD, Peking Union Medical College Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Peking Union Medical College Hospital
• ClinicalTrials.gov Identifier: NCT04655677
• Other Study ID Numbers: 0702-023
• First Posted: Dec 7, 2020
• Last Update Posted: Dec 7, 2020
• Last Verified: Jul 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Peking Union Medical College Hospital: CD19/CD20-directed CAR-T cells
• Additional relevant MeSH terms: Lymphoma, B-Cell

Study Results

No Results Posted as of Dec 7, 2020