B-cell Non-Hodgkin LymphomaPhase 1/2NCT06464185
A Prospective Clinical Study of CD3-CD20 Bisspecific Antibody Based Therapy Combined With CD19-CAR T Cells in the Treatment of Relapsed Refractory B-cell Non-Hodgkin Lymphoma
A Phase 1/2 study testing Bispecific antibody-based combined with CAR-T cell therapy in people with B-cell Non-Hodgkin Lymphoma, run by Institute of Hematology & Blood Diseases Hospital, China at 1 site in China.
Trial summary
The aim of this study was to analyze the safety and efficacy of CD3-CD20 bispecific antibody-based therapy in combination with CD19-CAR-T cells for the treatment of relapsed and refractory B-cell Non-Hodgkin's （B-NHL） lymphoma. The main questions it aims to answer： 1. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- B-cell Non-Hodgkin Lymphoma
- What is being tested?
- Bispecific antibody-based combined with CAR-T cell therapy
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteChina
- Study dates
- 27 May 2024to 30 Apr 2027
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patient has fully understood the study and voluntarily signed the informed consent form (ICF)
- Must meet the diagnostic criteria for relapsed and refractory B-NHL and have evaluable disease lesions, in addition to the following characteristics for different types of B-NHL:
- A, Diffuse large B-cell Lymphoma:
- Patients with histologically confirmed DLBCL; Patients who must have received ,anthracyclines CD20 monoclonal antibodies and BTK inhibitors and other Drug therapy, and have received at least two lines of treatment and relapsed, not relieved or progressed within 24 months after the last line of treatment;
- B, Relapsed and Refractory Follicular lymphoma (FL):
- Tissue Biopsy proved FL: grade 1-3a; Must have received anthracyclines and CD20 monoclonal antibody Drug therapy, and have received at least two lines of treatment and relapsed, not remitted or progressed within 24 months after the last line of treatment;
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- C, Relapsed and Refractory Marginal zone lymphoma (MZL):
- Histologically unequivocally confirmed MZL; Must have received anthracyclines and CD20 monoclonal antibody Drug therapy, and have received at least two lines of treatment and relapsed, not remitted or progressed within 24 months after the last line of treatment;
- D, Relapsed and refractory Mantle cell lymphoma (MCL):
- Histologically confirmed MCL; Relapsed or refractory after at least 2 lines of therapy (including anti-CD20 monoclonal antibody, anthracyclines or bendamustine, and BTKi);
- E, Relapsed and refractory CLL:
- Histologically confirmed CLL; Patients who have received at least Immunochemotherapy and have Drug therapy to both BTK inhibitors and BCL2 inhibitors Drug resistance;
- F, Relapsed and refractory WM:
- Patients with histologically confirmed WM; Patients who must have received anthracyclines, CD20 monoclonal antibodies and BTK inhibitors and other Drug therapy, and have received at least two lines of treatment and relapsed, not relieved or progressed within 24 months after the last line of treatment;
- ECOG score 0-1
- Laboratory test: Neutrophils 0.5 x 10 ^ 9/L; platelets 30 x 10 ^ 9/L; Bilirubin total 2 x upper limit; GPT/Glutamic-oxaloacetic transferase 3 x upper limit. Creatinine clearance ≥ 30 mL/min.
- The expected survival time of patients is ≥ 6 months;
Who cannot join
- Neoplasm malignant other than B-NHL (except active central nervous system lymphoma) diagnosed or treated within the past year; Patients who received anti Neoplasm therapy (including chemotherapy, targeted therapy, hormone therapy, traditional Chinese medicine with anti neoplasm activity, etc.) or participated in other clinical trials and received the investigational drug within 4 weeks before the first use of the investigational drug;
- Liver renal impairment not related to lymphoma: GPT (ALT) > 3 times the upper limit of normal, glutamic-oxaloacetic transferase (AST) > 3 times the upper limit of normal, bilirubin total (TBIL) > 2 times the upper limit of normal, serum creatinine clearance rate < 30ml/min;
- Other serious medical diseases that will affect the study (such as uncontrolled Diabetes mellitus, gastric ulcer, other serious heart lung disease, etc.), and the right to decide belongs to the investigator.
- Cardiac function and disease meet one of the following conditions:
- A, Long QTc syndrome or QTc interval > 480 MS; B, Complete left bundle branch block, grade II or III AV block; C, Serious, uncontrolled arrhythmia requiring drug therapy; D, New York Heart Association Heart disorder grade ≥ III; E, Cardiac Ejection Fraction (LVEF) less than 50%; F, Ischaemia, unstable Angina pectoris, history of severe unstable Ventricular arrhythmia or any other Arrhythmia requiring treatment, history of clinically significant Pericardial disease, or Electrocardiogram evidence of acute Myocardial infarction or active conduction system abnormalities within 6 months prior to recruitment;
- Known history of Infection human Immunodeficiency virus (HIV) or active Hepatitis B virus (HBV) Infection, or any uncontrolled active Injection requiring intravenous Systemic infection of antibiotics; Patients in the past 14 days received a large surgery (excluding lymph node Biopsy) or expected treatment in the need for a large Surgery;
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- Previous or current other neoplasm malignant (except effectively controlled skin Basal cell carcinoma without melanoma, breast/In situ cancer of cervix, and other effectively controlled Neoplasm malignant without treatment within the past five years
- Pregnancy or lactating women, women of childbearing age who did not take contraception measures;
- Hypersensitivity to the drugs or ingredients used;
Trial locations and contacts
1 site in 1 country.
China1 site
Institute of Hematology and Blood Diseases Hospital ,Chinese Academy of Medical Sciences
Tianjin, Tianjin Municipality
About this study
The aim of this study was to analyze the safety and efficacy of CD3-CD20 bispecific antibody-based therapy in combination with CD19-CAR-T cells for the treatment of relapsed and refractory B-cell Non-Hodgkin's （B-NHL） lymphoma.
The main questions it aims to answer：
- The safety of CD3-CD20 bispecific antibody-based therapy in combination with CD19-CAR-T cells in B-NHL;
- The effect of different doses of bispecific antibody maintenance therapy on CAR-T cell expansion.
Read the detailed description
The study was divided into two phases:
In the previous phase Ib clinical study, the bispecific antibody was used for bridging therapy to reduce the Neoplasm load, followed by CART cell therapy. After CART cell therapy, low-dose bispecific antibody was used for maintenance, in order to explore the safe resistance of bispecific antibody combined with CAR-T cell therapy and further explore the effect of bispecific antibody combined with CAR-T cell therapy on CART cell expansion; Phase II study will expand the sample study to further clarify whether bispecific antibody combined with CAR-T cell therapy can further deepen the efficacy of CAR-T.
- Conditions
- B-cell Non-Hodgkin Lymphoma
- Being tested
- Bispecific antibody-based combined with CAR-T cell therapy
- Keywords
- Glofitamab, CAR-T, obinutuzumab
- Medical subject headings
- Lymphoma, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bispecific antibody-based combined with CAR-T cell therapyDrug
lymphocytes collection, and bispecific antibody-based therapy will be performed after successful Lymphocytes collection: Obinutuzumab:1000mg, cycle 1 day 1(C1D1) ,IV.
Glofitamab: 2.5 mg, C1D8; 10 mg,C1D15 ; 30 mg,C2D1 and C3D1, IV. It can be combined with other Immunization therapy during the use of bispecific antibodies according to the patient's condition.
On C4D1, the patient will be pretreated with fludarabine and cyclophosphamide (FC) regimen, and then infused with CART cells at a specific dose of 2 * 1000000/Kg. Bispecific antibody maintenance therapy will be initiated approximately 1 month after CAR T-cell infusion and administered every 21 days for up to three cycles. In Phase1 bispecific maintenance therapy will be divided into three dose groups, using a "3 + 3" dose escalation design. In Phase 2, bispecific maintenance therapy will be used at the MTD dose of Phase 1.
| Study group | Role | What they receive |
|---|---|---|
| Bispecific antibody-based therapy combined with CAR-T cell therapy | Experimental | Not described Receives: Drug: Bispecific antibody-based combined with CAR-T cell therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence rate and severity of adverse events (AE) of patients treated with bispecific antibody combined with CD19-CAR-T cells in B-NHL.（Assessed by CTCAE criteria v5 and ASTCT 2019 criteria for CRS/ICANS adverse events.）
Assess the safety and toxicity of CD3-CD20 bispecific antibody-based therapy in combination with CD19-CAR-T cells in B-NHL. Assessed in all patients given at least one dose of study treatment and infused.
Measured: Up to 30 days after last treatment.From registration and during the bridging treatment, until end of post-treatment safety reporting window (up to six months after last dose of glofitamab)
Secondary outcomes (2)
Complete Response (CR) Rate
Measured: Up to 12 months after last treatment
Overall Response Rate (ORR)
Measured: Up to 12 months after last treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2024
- Study start27 May 2024
- Primary completion30 Mar 2026
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for B-cell Non-Hodgkin LymphomaStudies of the same condition, open and under way.
- More trials run by Institute of Hematology & Blood Diseases Hospital, ChinaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 53 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06464185
- Sponsor's protocol ID
- IIT2024021
- Status last verified
- May 2026
- First submitted
- 21 May 2024
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Clinical Study of CD3-CD20 Bisspecific Antibody Based Therapy Combined With CD19-CAR T Cells in the Treatment of Relapsed Refractory B-cell Non-Hodgkin Lymphoma
- ClinicalTrials.gov ID
- NCT06464185
- Acronym / sponsor ID
- IIT2024021
- Conditions
- B-cell Non-Hodgkin Lymphoma
- Keywords
- Glofitamab, CAR-T, obinutuzumab
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Institute of Hematology & Blood Diseases Hospital, ChinaUniversity, hospital or other
- Study start
- 27 May 2024 (actual)
- Primary completion
- 30 Mar 2026 (actual)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 18 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study was to analyze the safety and efficacy of CD3-CD20 bispecific antibody-based therapy in combination with CD19-CAR-T cells for the treatment of relapsed and refractory B-cell Non-Hodgkin's （B-NHL） lymphoma.
The main questions it aims to answer：
- The safety of CD3-CD20 bispecific antibody-based therapy in combination with CD19-CAR-T cells in B-NHL;
- The effect of different doses of bispecific antibody maintenance therapy on CAR-T cell expansion.
Detailed description
The study was divided into two phases:
In the previous phase Ib clinical study, the bispecific antibody was used for bridging therapy to reduce the Neoplasm load, followed by CART cell therapy. After CART cell therapy, low-dose bispecific antibody was used for maintenance, in order to explore the safe resistance of bispecific antibody combined with CAR-T cell therapy and further explore the effect of bispecific antibody combined with CAR-T cell therapy on CART cell expansion; Phase II study will expand the sample study to further clarify whether bispecific antibody combined with CAR-T cell therapy can further deepen the efficacy of CAR-T.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bispecific antibody-based therapy combined with CAR-T cell therapy | Experimental | Drug: Bispecific antibody-based combined with CAR-T cell therapy |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- The patient has fully understood the study and voluntarily signed the informed consent form (ICF)
- Must meet the diagnostic criteria for relapsed and refractory B-NHL and have evaluable disease lesions, in addition to the following characteristics for different types of B-NHL:
- Patients with histologically confirmed DLBCL; Patients who must have received ,anthracyclines CD20 monoclonal antibodies and BTK inhibitors and other Drug therapy, and have received at least two lines of treatment and relapsed, not relieved or progressed within 24 months after the last line of treatment;
- Tissue Biopsy proved FL: grade 1-3a; Must have received anthracyclines and CD20 monoclonal antibody Drug therapy, and have received at least two lines of treatment and relapsed, not remitted or progressed within 24 months after the last line of treatment;
- Histologically unequivocally confirmed MZL; Must have received anthracyclines and CD20 monoclonal antibody Drug therapy, and have received at least two lines of treatment and relapsed, not remitted or progressed within 24 months after the last line of treatment;
Key exclusion criteria (9 listed)
- Neoplasm malignant other than B-NHL (except active central nervous system lymphoma) diagnosed or treated within the past year; Patients who received anti Neoplasm therapy (including chemotherapy, targeted therapy, hormone therapy, traditional Chinese medicine with anti neoplasm activity, etc.) or participated in other clinical trials and received the investigational drug within 4 weeks before the first use of the investigational drug;
- Liver renal impairment not related to lymphoma: GPT (ALT) > 3 times the upper limit of normal, glutamic-oxaloacetic transferase (AST) > 3 times the upper limit of normal, bilirubin total (TBIL) > 2 times the upper limit of normal, serum creatinine clearance rate < 30ml/min;
- Other serious medical diseases that will affect the study (such as uncontrolled Diabetes mellitus, gastric ulcer, other serious heart lung disease, etc.), and the right to decide belongs to the investigator.
- Cardiac function and disease meet one of the following conditions:
- A, Long QTc syndrome or QTc interval > 480 MS; B, Complete left bundle branch block, grade II or III AV block; C, Serious, uncontrolled arrhythmia requiring drug therapy; D, New York Heart Association Heart disorder grade ≥ III; E, Cardiac Ejection Fraction (LVEF) less than 50%; F, Ischaemia, unstable Angina pectoris, history of severe unstable Ventricular arrhythmia or any other Arrhythmia requiring treatment, history of clinically significant Pericardial disease, or Electrocardiogram evidence of acute Myocardial infarction or active conduction system abnormalities within 6 months prior to recruitment;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bispecific antibody-based combined with CAR-T cell therapylymphocytes collection, and bispecific antibody-based therapy will be performed after successful Lymphocytes collection: Obinutuzumab:1000mg, cycle 1 day 1(C1D1) ,IV. Glofitamab: 2.5 mg, C1D8; 10 mg,C1D15 ; 30 mg,C2D1 and C3D1, IV. It can be combined with other Immunization therapy during the use of bispecific antibodies according to the patient's condition. On C4D1, the patient will be pretreated with fludarabine and cyclophosphamide (FC) regimen, and then infused with CART cells at a specific dose of 2 * 1000000/Kg. Bispecific antibody maintenance therapy will be initiated approximately 1 month after CAR T-cell infusion and administered every 21 days for up to three cycles. In Phase1 bispecific maintenance therapy will be divided into three dose groups, using a "3 + 3" dose escalation design. In Phase 2, bispecific maintenance therapy will be used at the MTD dose of Phase 1. | Drug | Bispecific antibody-based therapy combined with CAR-T cell therapy |
Primary outcome
Incidence rate and severity of adverse events (AE) of patients treated with bispecific antibody combined with CD19-CAR-T cells in B-NHL.（Assessed by CTCAE criteria v5 and ASTCT 2019 criteria for CRS/ICANS adverse events.）
Time frame: Up to 30 days after last treatment.From registration and during the bridging treatment, until end of post-treatment safety reporting window (up to six months after last dose of glofitamab)
Assess the safety and toxicity of CD3-CD20 bispecific antibody-based therapy in combination with CD19-CAR-T cells in B-NHL. Assessed in all patients given at least one dose of study treatment and infused.
2 secondary outcomes
Complete Response (CR) Rate
Time frame: Up to 12 months after last treatment
Overall Response Rate (ORR)
Time frame: Up to 12 months after last treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Bispecific antibody-based combined with CAR-T cell therapy in people with B-cell Non-Hodgkin Lymphoma, run by Institute of Hematology & Blood Diseases Hospital, China 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 17 inclusion and 9 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: under way, not looking for participants, as of the sponsor's last update on 27 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence rate and severity of adverse events (AE) of patients treated with bispecific antibody combined with CD19-CAR-T cells in B-NHL.（Assessed by CTCAE criteria v5 and ASTCT 2019 criteria for CRS/ICANS adverse events.） (time frame: Up to 30 days after last treatment.From registration and during the bridging treatment, until end of post-treatment safety reporting window (up to six months after last dose of glofitamab)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Oct 2026.