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Non-Hodgkin's LymphomaPhase 1/2NCT07882641

BEX101 in B-cell Non-Hodgkin's Lymphoma

A Phase 1/2 study testing BEX101 injection in people with Non-Hodgkin's Lymphoma, run by Chinese PLA General Hospital at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

BEX101 injection is an extracorporeal anti-CD19 Chimeric Antigen Receptor T-Cell (CAR-T cell) therapy product. This single-arm, open-label, phase I/II clinical study is designed to evaluate the safety and efficacy of BEX101 injection in patients with relapsed or refractory (r/r) B-cell non-Hodgkin's lymphoma (NHL) . Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Non-Hodgkin's Lymphoma
What is being tested?
BEX101 injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteChina
Study dates
15 Oct 2026to 30 Oct 2029
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age 18 to 75 years (inclusive), regardless of sex.
  • Subjects who meet the following diagnostic and treatment requirements:
  • 2.1 Any of the following B-cell non-Hodgkin lymphomas (B-NHL), confirmed by cytology or histology (according to the 2016 WHO Classification of Lymphoid Neoplasms):
  • 2.1.1 Diffuse large B-cell lymphoma, not otherwise specified (DLBCL, NOS);
  • 2.1.2 Primary mediastinal large B-cell lymphoma;
  • 2.1.3 DLBCL transformed from follicular lymphoma (FL), or marginal zone lymphoma (MZL);
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  • 2.1.4 High-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements;
  • 2.1.5 FL, grades 1-3b;
  • 2.1.6 Mantle cell lymphoma (MCL) (pathologically confirmed, with monoclonal B cells harboring t(11;14) and/or cyclin D1 overexpression);
  • 2.1.7 MZL [including nodal or splenic marginal zone B-cell lymphoma and mucosa-associated lymphoid tissue lymphoma];
  • 2.2 Relapsed or refractory disease during the screening period:
  • 2.2.1 Definition of relapsed disease: achievement of complete remission (CR) after first-line standard therapy (which must include rituximab and an anthracycline), with biopsy-confirmed disease relapse within 12 months after initiation of first-line treatment;
  • 2.2.2 Definition of refractory disease: failure to achieve CR after first-line standard therapy; subjects who are intolerant to first-line therapy are excluded. At least one of the following criteria must be met:
  • 2.2.2.1 Best response of progressive disease (PD) after first-line standard therapy;
  • 2.2.2.2 Best response of stable disease (SD) or PD after at least 4 cycles of first-line standard therapy (e.g., 4 cycles of R-CHOP);
  • 2.2.2.3 Best response of partial response (PR) after at least 6 cycles of first-line standard therapy, with biopsy-confirmed residual disease, followed by PD within 12 months;
  • 2.2.2.4 Failure to achieve remission after autologous stem cell transplantation (including SD and PD), or relapse within 12 months after achieving remission (including PR and CR);
  • 2.2.3 Subjects with transformed DLBCL must have received at least one line of therapy after transformation and have r/r disease after the most recent treatment;
  • 2.2.4 For subjects with MCL, prior treatment must have included an anthracycline- or bendamustine-containing regimen, anti-CD20 therapy (unless CD20-negative), and a BTK inhibitor;
  • 2.2.5 For subjects with indolent lymphoma (FL grades 1-3a and MZL), at least second-line prior therapy is required.
  • At least one measurable target lesion, defined as: longest diameter of an intra-nodal lesion > 1.5 cm; or longest diameter of an extra-nodal lesion > 1.0 cm (according to the 2014 Lugano Classification response criteria).
  • CD19-positive tumor tissue confirmed by histopathology. A prior CD19 pathology diagnosis may be accepted if confirmed by the investigator. Subjects previously treated with anti-CD19 therapy must undergo tumor biopsy to confirm current CD19-positive expression.
  • Any toxicities from prior therapies must be stable and recovered to Grade ≤ 1 (except for hematologic toxicities and clinically insignificant toxicities such as alopecia).
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1.
  • Organ function must meet the following criteria:
  • 7.1 Hematology: (No G-CSF permitted within 1 week prior to hematology testing, and no pegylated G-CSF within 2 weeks prior to testing): Absolute neutrophil count (ANC) ≥ 1.0 × 10^9/L; Platelet count (PLT) ≥ 50 × 10^9/L; Hemoglobin ≥ 60 g/L (This criterion does not apply to bone marrow suppression caused by lymphoma involvement of the bone marrow);
  • 7.2 Peripheral blood lymphocyte subsets: CD3+ T-lymphocyte count ≥ 100/μL;
  • 7.3 Coagulation function: International normalized ratio (INR) ≤ 1.5 × ULN; Activated partial thromboplastin time (APTT) ≤ 1.5 × ULN;
  • 7.4 Hepatic function: Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 × ULN (or ≤ 5 × ULN in the presence of liver metastases); Total bilirubin ≤ 1.5 × ULN;
  • 7.5 Renal function: Serum creatinine ≤ 1.5 × ULN, or Creatinine clearance (calculated by the Cockcroft-Gault formula) ≥ 60 mL/min;
  • 7.6 Cardiac function: Left ventricular ejection fraction (LVEF) ≥ 50% by echocardiography (ECHO); No pericardial effusion; No clinically significant abnormalities on 12-lead electrocardiogram (ECG);
  • 7.7 Pulmonary function: Oxygen saturation ≥ 92% on room air without supplemental oxygen; No clinically significant pleural effusion;
  • Subjects who are fertile, and/or whose partners are of childbearing potential, must agree to use effective contraception throughout the treatment period and for 24 months after completion of treatment, and must not donate ova or sperm for assisted reproduction during this period. Women of childbearing potential (women who have undergone sterilization or have been postmenopausal for ≥ 12 months are not considered to be of childbearing potential) must have a negative urine or serum pregnancy test during screening.
  • Willing to comply with all study procedures, voluntarily participate in the study, and sign the informed consent form.

Who cannot join

  • Estimated life expectancy < 3 months.
  • History of or concurrent active malignancy. Exceptions include curatively treated carcinoma in situ of the cervix, noninvasive basal cell or squamous cell skin cancer, locally confined prostate cancer after definitive treatment, or ductal carcinoma in situ after curative surgery, provided there has been no recurrence for at least 3 years;
  • Prior allogeneic stem cell transplantation, or autologous stem cell transplantation within 3 months prior to planned infusion of BEX101 injection.
  • History of central nervous system (CNS) disease or presence of clinically significant CNS dysfunction, such as cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, epilepsy, aphasia, or other similar conditions.
  • Myocardial infarction, cardiac angioplasty or stent implantation, unstable angina, or other clinically significant cardiac disease within 12 months prior to screening.
  • Lymphoma involvement of the atrium or ventricle.
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  • Presence of CNS metastases or symptoms suggestive of CNS metastases.
  • Ongoing or anticipated tumor-related emergency requiring treatment within 6 weeks after signing the informed consent form, such as mass effect from tumor bulk or tumor lysis syndrome.
  • Prior antitumor therapy for which the washout period has not exceeded 5 half-lives before the planned infusion of BEX101 injection.
  • Use of any of the following drugs or treatments within the specified time periods.
  • 10.1 Radiotherapy within 8 weeks prior to administration of the investigational product (except prophylactic treatment for CNS involvement).
  • 10.2 Alemtuzumab within 6 months prior to administration of the investigational product, or fludarabine or bendamustine within 3 months prior to administration.
  • 10.3 Other cytotoxic drug therapy within 2 weeks prior to administration of the investigational product.
  • 10.4 Corticosteroids or immunosuppressive therapy within 1 week prior to administration of the investigational product.
  • 10.5 Monoclonal antibody therapy within 3 weeks prior to administration of the investigational product.
  • Uncontrolled active bacterial, fungal, or viral infection, or any other infection that, in the investigator's judgment, makes the subject unsuitable for study participation.
  • Positive for HIV antibody, positive for Treponema pallidum antibody, positive for hepatitis B surface antigen (HBsAg), or positive for hepatitis B core antibody (HBcAb) with detectable peripheral blood HBV DNA, or positive for hepatitis C virus (HCV) antibody with detectable HCV RNA; exceptions may be made for infections considered preventable or controllable with medication in the investigator's judgment.
  • Known active autoimmune disease requiring systemic treatment.
  • Known severe hypersensitivity to any study medication or any of its components.
  • Pregnant or breastfeeding women.
  • Receipt of a live vaccine within 6 weeks prior to enrollment.
  • Participation in another interventional clinical study within 3 months prior to signing the informed consent form, receipt of active investigational drug treatment, or intention to participate in another clinical trial or receive treatment for autoimmune disease outside the protocol during the study period.
  • Patients with psychiatric disorders such as depression or suicidal ideation/tendency.
  • Any other medical condition that may affect the safety or efficacy evaluation of the investigational product.
  • Any other factor that, in the investigator's judgment, renders the subject unsuitable for enrollment or may interfere with the subject's participation in or completion of the study.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Weidong Han, M.D. contact

+86-010-66939460

hanwdrsw@sina.com

China1 site, 1 recruiting

  • Biotherapeutic Department of Chinese PLA General Hospital

    Beijing, Beijing Municipality, 100853

    Weidong Han, M.D., +86-010-66939460, hanwdrsw@sina.com

    Yang Liu, M.D.

    Recruiting

Other trials in China

About this study

Official title: A Phase I/II Clinical Study Evaluating the Safety and Efficacy of BEX101 in Patients With Relapsed/Refractory B-Cell Lymphoma

BEX101 injection is an extracorporeal anti-CD19 Chimeric Antigen Receptor T-Cell (CAR-T cell) therapy product. This single-arm, open-label, phase I/II clinical study is designed to evaluate the safety and efficacy of BEX101 injection in patients with relapsed or refractory (r/r) B-cell non-Hodgkin's lymphoma (NHL) .

Read the detailed description

CAR-T therapy has shown strong efficacy in r/r B-cell NHL. However, current CAR-T manufacturing is usually centralized and involves multiple complex steps. This lengthy process places high demands on manufacturing, logistics, and patient condition, and may limit timely treatment for patients with rapidly progressing disease or restricted access to medical resources.

To overcome these limitations, this study has developed a bedside extracorporeal (BEX) CAR-T manufacturing platform. Using a fully enclosed automated system, the BEX process enables continuous on-site preparation of CAR-T cells, including cell collection, CD19 CAR gene delivery, washing and resuspension, quality control, and infusion at the bedside. When predefined release criteria are met, the final cell product can be infused within 6 hours.

This study will be conducted to explore the safety and efficacy of BEX101 therapy in patients with r/r B-cell NHL who are positive for CD19 expression.

Being tested
BEX101 injection
Medical subject headings
Lymphoma, Non-Hodgkin

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BEX101 injectionBiological

    BEX101 injection is an extracorporeal anti-CD19 CAR-T cell therapy product.

Study groups in NCT07882641
Study groupRoleWhat they receive
Experimental: BEX101 injectionExperimentalAdministered by IV infusion
Receives: Biological: BEX101 injection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Dose limited toxicity (DLT) (phase 1)

    DLT is defined as any of the following adverse events (AEs) related to BEX101 injection infusion occurring within 28 days after BEX101 injection infusion (CRS and ICANS will be graded according to the ASTCT 2019 criteria, and other AEs will be evaluated using CTCAE v6.0):

    • Grade ≥ 3 neurotoxicity and/or CRS that does not resolve to Grade ≤ 2 within 7 days after therapeutic intervention;
    • Grade ≥ 3 non-hematologic toxicities other than CRS and neurotoxicity that do not resolve to Grade ≤ 2 within 14 days despite appropriate clinical treatment and management, excluding clinically insignificant laboratory abnormalities;
    • Grade ≥ 4 hematologic toxicities, including decreased neutrophil count and decreased platelet count, persisting for > 28 days after infusion of BEX101 injection.

    Measured: Within 28 days post-infusion

  2. Incidence and severity of AEs and serious AEs (SAEs) (phase 1)

    AEs refer to any adverse medical events occurring in subjects from the initiation of BEX101 administration during clinical trials. SAEs denote events involving death, life-threatening conditions, significant disability/incapacity, hospitalization or prolonged hospitalization arising after BEX101 administration in subjects.

    Measured: Within 24 months post-infusion

  3. Incidence and severity of AEs of special interest (AESI) (phase 1)

    AESI including grade ≥ 3 CRS, ICANS, and infections

    Measured: Within 24 months post-infusion

  4. Objective Response Rate (ORR) (phase 2)

    ORR includes CR and PR.

    Measured: Within 24 months post-infusion

Secondary outcomes (9)

  1. Incidence and severity of AEs (phase 2)

    AEs refer to any adverse medical events occurring in subjects from the initiation of BEX101 administration during clinical trials.

    Measured: Within 24 months post-infusion

  2. ORR (phase 1)

    ORR includes CR and PR.

    Measured: Within 24 months post-infusion

  3. Duration of Response (DOR) (phase 1 and phase 2)

    Time from first documented PR or CR to relapse or disease progression, or death from any cause.

    Measured: Within 24 months post-infusion

  4. Progression-Free Survival (PFS) (phase 1 and phase 2)

    Time from administration to disease progression or death from any cause, which ever occurs first.

    Measured: Within 24 months post-infusion

  5. Overall Survival (OS) (phase 1 and phase 2)

    Time from administration to death from any cause.

    Measured: Within 24 months post-infusion

  6. Number of CAR-positive T cells (phase 1 and phase 2)

    Number of CAR-positive T cells in peripheral blood.

    Measured: Within 24 months post-infusion

  7. CAR gene copy number (phase 1 and phase 2)

    CAR gene copy number in peripheral blood.

    Measured: Within 24 months post-infusion

  8. Number of CD19-positive cells (phase 1 and phase 2)

    Number of CD19-positive cells in peripheral blood.

    Measured: Within 24 months post-infusion

  9. Levels of cytokines (phase 1 and phase 2)

    Levels of cytokines in peripheral blood.

    Measured: Within 24 months post-infusion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Oct 2026
  2. Study start15 Oct 2026 (estimated)
  3. Primary completion30 Oct 2028 (estimated)
  4. Study completion30 Oct 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07882641
Sponsor's protocol ID
BEX101
Status last verified
Oct 2026
First submitted
12 Oct 2026
Last updated
22 Oct 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing BEX101 injection in people with Non-Hodgkin's Lymphoma, run by Chinese PLA General Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 34 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 22 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Weidong Han, M.D. (+86-010-66939460, hanwdrsw@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose limited toxicity (DLT) (phase 1) (time frame: Within 28 days post-infusion). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07882641.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2026.

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