A Study of EXP039 Treatment in Subjects With r/r NHL Subjects
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ClinicalTrials.gov Identifier: NCT04655677 |
Recruitment Status : Unknown
Verified July 2020 by Peking Union Medical College Hospital.
Recruitment status was: Recruiting
First Posted : December 7, 2020
Last Update Posted : December 7, 2020
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Condition or disease | Intervention/treatment | Phase |
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Non-Hodgkin's B-cell Lymphoma | Biological: CD19/CD20-directed CAR-T cells | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Estimated 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 : | August 25, 2020 |
Estimated Primary Completion Date : | July 2022 |
Estimated Study Completion Date : | October 2022 |

Arm | Intervention/treatment |
---|---|
Experimental: Autologous EXP039 administered by intravenous (IV) infusion
Autologous EXP039 administered by intravenous (IV) infusion
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Biological: CD19/CD20-directed CAR-T cells
Autologous 2nd generation CD19/CD20-directed CAR-T cells, single infusion intravenously
Other Name: EXP039 |
- Occurrence of study related adverse events [ Time Frame: 12 Months ]Incidence and severity of Treatment emergent adverse events
- Maximum concentration (Cmax) of EXP039 in the peripheral blood [ Time Frame: up to 12 months ]Detect CAR-T copies number by qPCR
- Time to maximum concentration (Tmax) of EXP039 in the peripheral blood [ Time Frame: up to 12 months ]Detect CAR-T copies number by qPCR
- Tlast of EXP039 in the peripheral blood after infusion [ Time Frame: up to 12 months ]Detect CAR-T copies number by qPCR
- AUC0h-28d of EXP039 in the peripheral blood [ Time Frame: 4 weeks ]Detect CAR-T copies number by qPCR
- Objective response rate (ORR) [ Time Frame: 4 weeks, 12 weeks, 6 months, 9 months, 12 months ]Complete response (CR) rate plus partial response (PR) rate by Lugano 2014 criteria
- Duration of response (DOR) [ Time Frame: up to 12 months ]The time from the date of first response (PR or better) until the date of disease progression after EXP039 infusion
- Progression-free survival (PFS) [ Time Frame: 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
- Overall survival rate (OSR) [ Time Frame: 12 weeks, 6 months, 12 months ]The time from EXP039 infusion to the date of death

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- The patient volunteered to participate in the study and signed the Informed Consent
- Age ≥18 years old ≤70 Years old, male or female
- Expected survival ≥ 12 weeks
- ECOG score 0-2
- CD19 or CD20 positive B-NHL confirmed by cytology or histology according to WHO2016 criteria
- Patients with a clear diagnosis of relapsed and/or refractory B-NHL, including DLBCL, FL and MCL
- 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
Exclusion Criteria:
- 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
- Active HIV, HBV, HCV 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 therapy
- 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 EXP039
- Patients with central nervous system involvement
- Any systemic antitumor therapy performed within 2 weeks before enrollment
- Previous use of any CAR T cell product or other genetically modified T cell therapy

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04655677
Contact: Daobin Zhou, PhD&MD | 010-69155020 | zhoudb@pumch.cn | |
Contact: Yan Zhang | 010-69155660 | zhangyan10659@pumch.cn |
China, Beijing/China | |
Peking Union Medical College Hospital | Recruiting |
Beijing, Beijing/China, China, 100000 | |
Contact: Daobin Zhou, PhD&MD 010-69155020 zhoudb@pumch.cn |
Principal Investigator: | Daobin Zhou, PhD&MD | Peking Union Medical College Hospital |
Responsible Party: | Peking Union Medical College Hospital |
ClinicalTrials.gov Identifier: | NCT04655677 |
Other Study ID Numbers: |
0702-023 |
First Posted: | December 7, 2020 Key Record Dates |
Last Update Posted: | December 7, 2020 |
Last Verified: | July 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
CD19/CD20-directed CAR-T cells |
Lymphoma, B-Cell Lymphoma, Non-Hodgkin Lymphoma Neoplasms by Histologic Type Neoplasms |
Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases |