AzTrials
AzTrials

CD20-positive Non-Hodgkin LymphomaPhase 1/2NCT06021678

Safety and Efficacy of EX103 in Subjects with Relapsed/Refractory CD20-Positive Non-Hodgkin Lymphoma

A Phase 1/2 study testing EX103 injection in people with CD20-positive Non-Hodgkin Lymphoma, run by Guangzhou Excelmab Inc. at 4 sites 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

This is a multicenter, single-arm, open, dose-escalation Phase I/II clinical trial, consisting of a dose-escalation phase (accelerated titration phase, 3+3 design) and a dose expansion phase. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
CD20-positive Non-Hodgkin Lymphoma
What is being tested?
EX103 injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
415 participants
Where
4 sitesChina
Study dates
12 Nov 2021to Dec 2025
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • -
  • 1. Provision of signed and dated informed consent form; stated willingness to comply with all study procedures and availability for the duration of the study; 2. Aged ≥ 18 years old, male or female; 3. Meeting the following criteria:
  • Dose-escalation phase: (1) with CD20-positive non-Hodgkin lymphoma confirmed at the first diagnosis (excluding patients whose CD20 turned negative after rituximab treatment); (2) with relapsed or refractory disease after least 2 prior lines of systemic therapy; (3) currently with no suitable therapy available for prolonging survival;
  • Dose-expansion phase:
  • Cohort 1:
  • Histopathologically and immunohistochemically confirmed CD20-positive diffuse large B-cell lymphoma (DLBCL) (excluding patients whose CD20 turned negative after rituximab treatment) : including non-specific (NOS) DLBCL, high-grade B-cell lymphoma (HGBCL), primary mediastinal (thymus) large B-cell lymphoma (PMBCL), and translational follicular lymphoma (trFL) (patients who have converted from follicular lymphoma to DLBCL can be enrolled, and pathology reports should be provided at the same time if there is a disease transformation), or follicular lymphoma (FL) with histological grade 3b; the sponsor may limit the number of patients with PMBCL and trFL enrolled;
Show all 28Show fewer
  • Previous failure or relapse after second-line or higher systemic treatment regimens (at least one of which included anti-CD20 targeted therapy and at least one of which included anthracyclines);
  • Cohort 2:
  • Histopathologically and immunohistochemically confirmed CD20-positive follicular lymphoma (FL) (excluding patients whose CD20 turned negative after rituximab treatment);
  • The histological grade ranged from 1 to 3a;
  • Previous failure or recurrence of second-line or higher systemic regimens (at least one of which included anti-CD20 targeted therapies and alkylating agents; The sponsor may limit the minimum number of patients who are refractory to both anti-CD20-targeted therapies and alkylating agents);
  • Must be indicative of treatment due to symptoms and/or tumor burden;
  • Cohort 3:
  • Histopathologically and immunohistochemically confirmed CD20-positive non-Hodgkin lymphoma (excluding patients with CD20 turning negative after rituximab treatment), other than the types included in cohort 1 and cohort 2; the sponsor may limit the number of patients with certain or several specific tumor species to be enrolled;
  • Previous failure or relapse after second-line or higher standard treatment, at least one of which included a combination of anti-CD20 monoclonal antibodies and chemotherapy agents;
  • In cases of indolent lymphoma, indications for treatment must be present due to symptoms and/or tumor burden;
  • 4. At the dose escalation and expansion stages, the subjects must have at least one two- dimensionally measurable lesion as the basis for evaluation by CT, or MRI, if CT is not applicable: for intranodal lesions, the long diameter is ≥ 1.5 cm; for extranodal lesions, the long diameter is ≥ 1.0 cm;
  • 5. ECOG performance status score: 0-2;
  • 6. Life expectancy ≥ 12 weeks;
  • 7. The laboratory test results should be met before each cycle beyond cycle 1 (blood components, short-acting cell growth factors, albumin, and other drugs are not allowed to be given within the first 7 days of laboratory tests; long-acting cell growth factors are not allowed to be given within the first 14 days):
  • Absolute neutrophil count ≥ 1.0×109/L;
  • Platelet count ≥ 50×109/L;
  • Hemoglobin ≥ 80 g/L;
  • Serum total bilirubin ≤ 1.5×ULN; if there is liver invasion, serum total bilirubin ≤ 3×ULN;
  • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5×ULN; if there is liver invasion, ALT and AST ≤ 5×ULN;
  • Serum creatinine ≤1.5×ULN or creatinine clearance estimated by Cockcroft-Gault formula ≥ 30 mL/min;
  • International normalized ratio (INR) or plasma prothrombin time (PT) ≤ 1.5×ULN;
  • 8. Women of childbearing potential and men with a partner of childbearing potential who consent to use highly effective methods of birth control during treatment and for an additional 90 days after the last administration of the protocol specified treatment; women of childbearing age without surgical sterilization must have a negative result in serum HCG test within 7 days before enrollment in the study and isn't breastfeeding.

Who cannot join

  • Clear history of drug allergy, foreign protein, biologics or ingredients of investigational drugs;
  • Uncontrolled active infection during the screening period;
  • Previously received allogeneic hematopoietic stem cell transplantation or solid organ transplant; or received autologous hematopoietic stem cell transplantation (HSCT) or CAR-T cell therapy within 3 months;
  • CNS metastases, or other serious central nervous system diseases (such as epilepsy, cerebral infarction, and cerebral hemorrhage) within 6 months, History of neurodegenerative condition or CNS movement disorder. Subjects with a history seizure within 12 months prior to study enrollment are excluded;
  • At least one active person is known to have human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV). Subjects with evidence below are eligible for study entry:
  • Human immunodeficiency virus antibody (HIV-Ab) is negative;
Show all 14Show fewer
  • Hepatitis B surface antigen (HBsAg) is negative; when HbsAg or HbcAb is positive, HBV-DNA (HBV deoxyribonucleic acid) is < lower limit of detection;
  • Hepatitis C virus antibody is positive, and HCV RNA is negative.
  • Toxicities caused by previous anti-tumor therapy has not recovered to grade ≤ 1 (CTCAE v5.0), except alopecia and other tolerable events as determined by the investigator;
  • Develop any other malignancy within 5 years (except for completely treated cervical carcinoma in situ or basal cell or squamous cell skin cancer);
  • Use of any vaccine within 4 weeks prior to initial pretreatment with dexamethasone or methylprednisolone or during the intended study period;
  • Systemic immunosuppressive drugs, including but not limited to radiotherapy immune conjugate, antibody drug conjugations, immune/cytokines, monoclonal antibodies, etc., have been used within 4 weeks prior to initial pretreatment with dexamethasone or methylprednisolone.
  • With a history of active autoimmune diseases, including but not limited to myocarditis, pneumonia, myasthenia gravis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, Wegener's granulomatosis, multiple sclerosis, vasculitis, or glomerulonephritis;
  • Any condition that the investigator believes may not be appropriate for participating in the study.

Trial locations and contacts

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

Jiali Lu, MD, PHD contact

86-02028211020

jiali.lu@excelmab.com

Yanfei Li contact

86-13242086880

yanfei.li@excelmab.com

China4 sites, 4 recruiting

  • Qilu Hospital, Cheeloo College of Medicine, Shandong University

    Jinan, Shandong, 250012

    Chunyan Ji, MD, jichunyan@sdu.edu.cn

    Fei Lu, MD, lufeisdu2@163.com

    Recruiting

  • Shanghai Sixth People's Hospital, Shanghai Jiaotong University school of Medicine

    Shanghai, Shanghai Municipality, 200233

    Chunkang Chang, MD, 86-13764643870, Changchunkang7010@aliyun.com

    Recruiting

  • Institute of Hematology and Blood Disease Hospital, Chinese Academy of Medical Sciences

    Tianjin, Tianjin Municipality, 300020

    Junyuan Qi, MD. PHD, qijy@ihcams.ac.cn

    Mingyuan Sun, MD, sunmingyuan@ihcams.ac.cn

    Recruiting

  • Cancer Hospital Affiliated to Zhengzhou University, Henan Cancer Hospital

    Zhengzhou, Henan, 450000

    Keshu Zhou, MD, drzhouks77@163.com

    Recruiting

Other trials in China

About this study

Official title: A Phase I/II Study Evaluating the Safety, Efficacy, and Pharmacokinetics of EX103 in Subjects with Relapsed/Refractory CD20-Positive Non-Hodgkin Lymphoma

This is a multicenter, single-arm, open, dose-escalation Phase I/II clinical trial, consisting of a dose-escalation phase (accelerated titration phase, 3+3 design) and a dose expansion phase.

Read the detailed description

Based on the safety, tolerability, PK results, and antitumor activity of EX103 in patients with relapsed or refractory CD20-positive non-Hodgkin lymphoma, this study will determine dose-limiting toxicity (DLT) and determine the maximum tolerated dose (MTD) or optimal biological dose (OBD) to provide a basis for the recommended Phase 2 dose (RP2D). The dose expansion phase will further evaluate the safety, tolerability, PK, PD profile, initial antitumor effect, and immunogenicity of several extended cohorts.

Being tested
EX103 injection

What participants receive

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

  • EX103 injectionDrug

    Also called EX103, bispecific monoclonal antibody that recognizes both CD3 and CD20

    Administered as specified in the treatment arm.

Study groups in NCT06021678
Study groupRoleWhat they receive
EX103 injectionExperimentalFrom Cycle 0 to Cycle 2, the subject will receive the preset dose of EX103 once a week (QW), and from Cycle 3, the subject will receive the preset dose of EX103 once every two weeks (Q2W). The recommended dose is MTD or OBD, and a cycle of treatment is 28 days.
Receives: Drug: EX103 injection

What is being measured

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

  1. Incidence of Dose Limiting Toxicities (DLTs) [dose escalation (Cycle 0 and Cycle 1)]

    To determine the RP2D and the MTD, if reached.

    Measured: During the DLT evaluation period (28 days from Cycle1 Day1 at the dose escalation stage).

  2. Safety endpoints：incidence and severity of adverse events (AE), laboratory tests, etc.

    Treatment-emergent AEs (TEAEs) as assessed by CTCAE v5.0. Abnormal laboratory values are reported as AEs per protocol.

    Measured: From first dose until the end of the safety follow-up period [within 28 ± 7 days after the last study treatment or before the start of other anti-tumor treatments (whichever occurs earlier)].

Secondary outcomes (16)

  1. All parts: Time to reach Cmax (Tmax)

    Tmax is one of the characteristics of Pharmacokinetic (PK) endpoint.

    Measured: From first dose until treatment discontinuation, expected average of 3.5 years.

  2. All parts: Maximum (peak) plasma concentration (Cmax)

    Cmax is one of the characteristics of Pharmacokinetic (PK) endpoint.

    Measured: From first dose until treatment discontinuation, expected average of 3.5 years.

  3. All parts: Area under the concentration-time curve from time 0 to the last measurable concentration using linear-log trapezoidal rule (AUC0-t)

    AUC0-t is one of the characteristics of Pharmacokinetic (PK) endpoint.

    Measured: From first dose until treatment discontinuation, expected average of 3.5 years.

  4. All parts: Elimination half-life (t 1/2)

    t 1/2 is one of the characteristics of Pharmacokinetic (PK) endpoint.

    Measured: From first dose until treatment discontinuation, expected average of 3.5 years.

  5. All parts: Total body clearance of drug from the plasma (CL)

    CL is one of the characteristics of Pharmacokinetic (PK) endpoint.

    Measured: From first dose until treatment discontinuation, expected average of 3.5 years.

  6. All parts: Steady-state maximum plasma concentration(Css,max)

    Css,max is one of the characteristics of Pharmacokinetic (PK) endpoint.

    Measured: From first dose until treatment discontinuation, expected average of 3.5 years.

  7. All parts: Steady-state minimum plasma concentration(Css,min)

    Css,min is one of the characteristics of Pharmacokinetic (PK) endpoint.

    Measured: From first dose until treatment discontinuation, expected average of 3.5 years.

  8. All parts: Steady-state time to maximum concentration(Tss,max)

    Tss,max is one of the characteristics of Pharmacokinetic (PK) endpoint.

    Measured: From first dose until treatment discontinuation, expected average of 3.5 years.

  9. All parts: Area under the plasma concentration versus time curve at Steady-State(AUCss)

    AUCss is one of the characteristics of Pharmacokinetic (PK) endpoint.

    Measured: From first dose until treatment discontinuation, expected average of 3.5 years.

  10. All parts: Pharmacodynamic (PD) endpoint

    Before and after administration of EX103, changes in lymphocyte subsets and peripheral blood cytokine levels.

    Measured: From first dose until treatment discontinuation, expected average of 3.5 years.

  11. All parts: Objective response rate (ORR)

    ORR is defined as the proportion of subjects whose optimal response is CR or CRi or PR. Subjects who did not undergo tumor evaluation after baseline were considered to have no objective, as determined by the investigator using Lugano 2014 criteria.

    Measured: From first dose until treatment discontinuation, expected average of 3.5 years.

  12. All parts: Disease control rate (DCR)

    DCR is defined as the proportion of subjects whose best response is CR or CRi or PR or SD.

    Measured: From first dose until treatment discontinuation, expected average of 3.5 years.

  13. All parts: Duration of response (DoR)

    Duration of response (DoR) is defined as the time between the first onset of CR or CRi or PR and the onset of PD or death from any cause, whichever occurs first, in subjects with objective response.

    Measured: From first dose until treatment discontinuation, expected average of 3.5 years.

  14. All parts: Incidence of anti-drug antibodies (ADA)

    Percentage of positive patients of anti-drug antibody.

    Measured: From first dose until treatment discontinuation, expected average of 3.5 years.

  15. All parts: Incidence of neutralizing antibody (NAb)

    Percentage of positive patients of neutralizing antibody.

    Measured: From first dose until treatment discontinuation, expected average of 3.5 years.

  16. All parts: Confirmation of anti-drug antibody and neutralizing antibodies.

    Screening of antibodies against corresponding antigens and confirmation of positive antibodies, and determination of the titers of related antibodies (IgG, etc.) produced in the humoral and cellular immunity.

    Measured: From first dose until treatment discontinuation, expected average of 3.5 years.

Timeline

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

  1. First posted1 Sep 2023
  2. Study start12 Nov 2021
  3. Primary completionOct 2025 (estimated)
  4. Study completionDec 2025 (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
Sequential
Masking
None (open label)
Enrolment
415 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06021678
Sponsor's protocol ID
EX103-001
Status last verified
Feb 2025
First submitted
22 Aug 2023
Last updated
27 Feb 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing EX103 injection in people with CD20-positive Non-Hodgkin Lymphoma, run by Guangzhou Excelmab Inc. at 4 sites 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 28 inclusion and 14 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 27 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites 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 Jiali Lu, MD, PHD (86-02028211020, jiali.lu@excelmab.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Dose Limiting Toxicities (DLTs) [dose escalation (Cycle 0 and Cycle 1)] (time frame: During the DLT evaluation period (28 days from Cycle1 Day1 at the dose escalation stage).). The study lists 2 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 NCT06021678.

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 27 Feb 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in