A Study of EXP039 Treatment in Subjects With r/r NHL Subjects
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ClinicalTrials.gov Identifier: NCT04693676 |
Recruitment Status : Unknown
Verified November 2020 by First Affiliated Hospital of Zhejiang University.
Recruitment status was: Recruiting
First Posted : January 5, 2021
Last Update Posted : April 13, 2021
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This is a single-arm, open label, dose escalation, phase I study of EXP039 in adults with relapsed/refractory B-cell Non-Hodgkin's Lymphoma.
Condition of disease:B cell Non-Hodgkin's Lymphoma Intervention/treatment: Biological/Vaccine: CD19/CD20-direct CAR-T cells. phase: phase 1
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Non-Hodgkin's B-cell Lymphoma | Biological: CD19/CD20-directed CAR-T cells | Phase 1 |
This is a single-arm, open label, "3+3" dose escalation, phase I study to evaluate the safety and preliminary efficacy of EXP039 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 EXP039. Following manufacture of the drug product, subjects will receive lymphodepleting therapy with fludarabine and cyclophosphamide prior to EXP039 infusion. All subjects who have received EXP039 infusion will be followed for up to 12 months.
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 : | July 10, 2020 |
Estimated Primary Completion Date : | July 10, 2022 |
Estimated Study Completion Date : | October 10, 2022 |

Arm | Intervention/treatment |
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Experimental: EXP039
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 |
- MTD [ Time Frame: up to12 Months ]maximum tolerated dose or clinical recommended dose
- DLT [ Time Frame: up to 28 days after EXP039 infusion ]Dose limiting toxicity
- AE/SAE/AESI [ Time Frame: up to12 Months ]adverse events (AE), serious adverse event (SAE), pay particular attention to adverse events (AESI) (including cytokine release syndrome (CRS), and nerve toxicity), laboratory tests (type, frequency and severity), vital signs and ECG abnormality rate.
- EXP039 CAR expansion and persistence [ Time Frame: up to12 Months ]After EXP039 infusion, peripheral blood EXP039 CAR expansion and persistence in vivo.
- Objective response rate (ORR) [ Time Frame: Time Frame 4weeks,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: 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: Time Frame: 4weeks, 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: 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 between 18 and 70 (including 18 and 70), 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.
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;
- Any uncontrolled, active disease that prevents participation in the trial;
- 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 was performed within 2 weeks before conditional treatment chemotherapy pretreatment;
- Prior 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): NCT04693676
Contact: Jie Jin, PhD&MD | +86-0571-87236702 | jiej0503@163.com |
China, Zhejiang | |
First Affiliated Hospital of Zhejiang University College of Medicine | Recruiting |
Hangzhou, Zhejiang, China, 310003 | |
Contact: Jie Jin, PhD&MD +86-0571-87236702 jiej0503@163.com |
Principal Investigator: | Jie Jin, PhD&MD | First Affiliated Hospital of Zhejiang University College of Medicine |
Responsible Party: | First Affiliated Hospital of Zhejiang University |
ClinicalTrials.gov Identifier: | NCT04693676 |
Other Study ID Numbers: |
0702-025 |
First Posted: | January 5, 2021 Key Record Dates |
Last Update Posted: | April 13, 2021 |
Last Verified: | November 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 |
Lymphoma, B-Cell Lymphoma, Non-Hodgkin Lymphoma Neoplasms by Histologic Type Neoplasms |
Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases |