A Study Evaluating Safety and Efficacy of EXP039 Treatment in NHL Subjects

• Sponsor: Shanghai Tongji Hospital, Tongji University School of Medicine (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04317885
• Collaborator: (none)
• Enrollment: 25
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 21.6
• Patients Per Site Per Month: 1.2

Study Details

Study Description

Brief Summary

The trial is a single arm, single-center, non-randomized phase I clinical trial which is designed to evaluate the safety and efficacy of EXP039 in treatment of relapsed 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

This study plans to enroll 25 patients to assess the safety and efficacy of EXP039. Subjects who meet the eligibility criteria will receive a single dose of EXP039 injection.

The study will include the following sequential phases: Screening, Pre-treatment (Cell product preparation; Lymphodepleting Chemotherapy), Treatment and follow-up.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 25 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Study Evaluating Safety and Efficacy of EXP039 Treatment in Relapsed or Refractory NHL Subjects
• Actual Study Start Date: Oct 14, 2019
• Anticipated Primary Completion Date: Aug 1, 2021
• Anticipated Study Completion Date: Aug 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: EXP039 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 weeks]

   Incidence and severity of Treatment emergent adverse events

Secondary Outcome Measures

1. Overall response rate (ORR) [12 months]

   Lugano criteria(NHL,2014).

2. Duration of remission (DOR) [12 months]

3. Progression free survival (PFS) [12 months]

4. Overall survival (OS) [12 weeks, 6 months, 12 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• 1. Volunteered to participate in this study and signed informed consent
• 1. Age 18-75 years old, male or female
• 1. Patients with relapsed or refractory B-NHL;
• 1. At least one measurable lesion (LDi ≥ 1.5 cm);
• 1. At least two weeks from the end of treatment regimen (radiation, chemotherapy, mAb, etc) to apheresis;
• 1. LVEF≥ 50% (UCG)
• 1. No active pulmonary infections, normal pulmonary function and SpO2≥92%
• 1. Laboratory criteria: ANC≥1.0×109/L; Platelets≥50×109/L; Serum total bilirubin ≤1.5x ULN; Creatinine≤ ULN; AST and ALT≤3x ULN
• 1. No contraindications of apheresis;
• 1. Expected survival ≥ 3months
• 1. ECOG score 0 or 1

• 12.The apheresis was received by laboratory and met the requirements for manufacturing CAR-T cell.

Exclusion Criteria:

• 1. Have a history of allergy to cellular products;
• 1. According to the NYHA cardiac function grading standards, patients with grade III or IV cardiac dysfunction;
• 1. A history of craniocerebral trauma, disturbance of consciousness, epilepsy, cerebrovascular ischemia, cerebrovascular hemorrhagic disease, etc.;
• 1. Patients with central nervous system involvement;
• 1. Patients with autoimmune diseases, immunodeficiency or other conditions requiring immunosuppressive therapy;
• 1. Received allogeneic hematopoietic stem cell transplantation before;
• 1. Previous use of any CAR T cell product or other genetically modified T cell therapy;
• 1. Autologous stem cell transplantation within 6 weeks before infusion;
• 1. Severe active infections (except for simple urinary tract infections, bacterial pharyngitis), or currently undergoing intravenous infusion of antibiotics, or intravenous infusion of antibiotics within 1 week prior to cell infusion. However, prophylactic antibiotic, antiviral and antifungal infection treatments are permissible;
• 1. Live vaccination within 4 weeks prior to apheresis;
• 1. People infected with HIV, HBV, HCV and TPPA/RPR, and carriers with HBV;
• 1. A history of alcohol abuse, drug use or mental illness;
• 1. Subjects who are not sterilized have any of the following conditions:

1. are pregnant/lactating; or

2. planned pregnancy during the trial; or

3. being fertile and unable to use effective contraception;

• 1. Severe hypersensitivity to fludarabine or cyclophosphamide;
• 1. A history of other primary cancers other than the following:

1. Non-melanoma tumors such as basal cell carcinoma of the skin that are cured by excision

2. Cured in situ cancers such as cervical, bladder, or breast cancer

• 1. The investigators consider that the subject has other conditions that are not suitable for this trial.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Shanghai Tongji Hospital, Tongji University School of Medicine	Shanghai	Shanghai	China	200065

Sponsors and Collaborators

• Shanghai Tongji Hospital, Tongji University School of Medicine

Investigators

• Principal Investigator: Aibin Liang, MD, Ph.D, Shanghai Tongji Hospital, Tongji University School of Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Aibin Liang，MD，Ph.D., Director, Department of Hematology, Shanghai Tongji Hospital, Tongji University School of Medicine
• ClinicalTrials.gov Identifier: NCT04317885
• Other Study ID Numbers: 0702-015
• First Posted: Mar 23, 2020
• Last Update Posted: Sep 25, 2020
• Last Verified: Sep 1, 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Lymphoma, B-Cell

Study Results

No Results Posted as of Sep 25, 2020