Relapsed or Refractory Aggressive B-cell LymphomaPhase 2NCT06996132
Bispecific Antibody-Based Salvage Therapy Followed by CAR-T ± ASCT in R/R Aggressive B-Cell Lymphoma
A Phase 2 study testing Glofitamab and Chimeric Antigen Receptor T Cells (CAR-T) in people with Relapsed or Refractory Aggressive B-cell Lymphoma, run by Institute of Hematology & Blood Diseases Hospital, China at 1 site in China.
Trial summary
This study consists of two sequential treatment phases. In the first phase, patients with r/r aggressive B-NHL receive two cycles of glofitamab ± investigator-selected agents. In the second phase, patients eligible for CAR-T monotherapy undergo FC lymphodepletion followed by CAR-T infusion (2-4×10⁶/kg), while those… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Relapsed or Refractory Aggressive B-cell Lymphoma
- What is being tested?
- Glofitamab and Chimeric Antigen Receptor T Cells (CAR-T)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteChina
- Study dates
- 9 May 2025to 30 Dec 2027
- Phase
- Phase 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with relapsed/refractory aggressive B-cell lymphoma, including the following subtypes: diffuse large B-cell lymphoma (DLBCL), high-grade B-cell lymphoma (HGBL), or transformed large B-cell lymphoma.
- Relapsed or refractory disease, meeting criteria for one of the following cohorts:
- Cohort 1 (Relapsed/Refractory Disease):
- ≥2 prior lines of therapy (including both anti-CD20 monoclonal antibody and anthracycline-based chemotherapy) with documented progression following last treatment; OR
- Failure of first-line immunochemotherapy (containing anti-CD20 antibody and anthracycline) defined by any of:
- Relapse/progression within 12 months of treatment completion; OR
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- Progressive disease during first-line therapy; OR
- Stable disease as best response after 4 cycles; OR
- Partial response as best response after 6 cycles.
- Cohort 2 (Early Treatment Failure):
- Persistent metabolic activity (Deauville 5) on PET-CT after 2 cycles of first-line immunochemotherapy; OR
- Biopsy-proven residual disease following initial therapy.
- Age ≥18 years and ≤65 years.
- Eastern Cooperative Oncology Group (ECOG) performance status ≤2.
- Hematologic parameters at screening must meet the following (unless due to bone marrow involvement):
- Absolute neutrophil count (ANC) ≥1×10⁹/L,
- Platelet count (PLT) ≥75×10⁹/L.
- Biochemical parameters at screening must meet the following:
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3× upper limit of normal (ULN);
- Total bilirubin (TBIL) ≤1.5×ULN (unless due to Gilbert's syndrome or non-hepatic causes);
- Serum creatinine (Cr) ≤2×ULN OR creatinine clearance ≥40 mL/min.
- Left ventricular ejection fraction (LVEF) within institutional normal range by echocardiography.
- Baseline oxygen saturation >92% on room air.
- Life expectancy ≥3 months as assessed by the investigator.
Who cannot join
- Confirmed primary central nervous system lymphoma;
- Prior autologous or allogeneic hematopoietic stem cell transplantation;
- Active HBV or HCV infection, defined as HBV-DNA or HCV-RNA levels above the upper limit of detection.
- Uncontrolled comorbidities include infectious diseases, cardiovascular/cerebrovascular disorders, coagulopathies, and connective tissue diseases.
- History of epilepsy or other central nervous system disorders;
- Pregnancy or lactation;
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- HIV infection;
- History of other malignancies unless:
- Disease-free for ≥5 years, or
- Previously cured of the following:
- Non-melanoma skin cancers (basal cell carcinoma, squamous cell carcinoma, or related localized cutaneous malignancies)
- Carcinoma in situ of cervix
- Other conditions deemed ineligible by investigators.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Institute of Hematology & Blood Diseases Hospital
Tianjin, 022
SHUO CHEN, 022-23909095, ec@ihcams.ac.cn
About this study
Official title: A Phase 2 Clinical Study of CD20×CD3 Bispecific Antibody-Based Salvage Therapy Followed by CAR-T With or Without ASCT in R/R Aggressive B-Cell Lymphoma
This study consists of two sequential treatment phases. In the first phase, patients with r/r aggressive B-NHL receive two cycles of glofitamab ± investigator-selected agents. In the second phase, patients eligible for CAR-T monotherapy undergo FC lymphodepletion followed by CAR-T infusion (2-4×10⁶/kg), while those eligible for CAR-T+ASCT receive conditioning chemotherapy with PBSC reinfusion on day 0 and CAR-T administration (2-4×10⁶/kg) on day +3 (±1). Patients demonstrating Deauville 4-5 or ctDNA positivity at day 28 post-CAR-T infusion subsequently receive four cycles of glofitamab consolidation therapy.
Read the detailed description
The study comprises two sequential treatment phases. In the first phase, eligible patients with r/r aggressive B-NHL receive 2 cycles of glofitamab ± X regimen (where X includes but is not limited to chemotherapy, antibody-drug conjugates, or small-molecule targeted agents, selected at the investigator's discretion). Peripheral blood lymphocyte apheresis is performed prior to initial glofitamab administration unless clinically contraindicated, with hematopoietic stem cell mobilization and collection timed per investigator assessment to achieve minimum required yields of ≥3×10⁸/kg mononuclear cells and ≥2×10⁶/kg CD34+ cells.
Patients successfully completing phase 1 proceed to phase 2 treatment. In the CAR-T alone cohort, patients receive FC lymphodepleting therapy (days -5 to -3) followed by CAR-T cell infusion (2-4×10⁶/kg) on day 0. The CAR-T+ASCT cohort undergoes conditioning chemotherapy (regimen determined by investigator) with autologous PBSC reinfusion on day 0 and CAR-T cells (2-4×10⁶/kg) administered on day +3 (±1 day).
At day 28 post-CAR-T infusion, patients demonstrating PET-CT Deauville scores of 4-5 or ctDNA positivity initiate 4 cycles of glofitamab consolidation therapy.
- Being tested
- Glofitamab, Chimeric Antigen Receptor T Cells (CAR-T)
- Keywords
- Glofitamab, CAR T-cell therapy, autologous stem cell transplantation
- Medical subject headings
- Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GlofitamabDrug
Glofitamab is administered as monotherapy or in combination with investigator-selected agents (including but not limited to chemotherapy, ADCs, BTK inhibitors, etc.) for 2 cycles.
Chimeric Antigen Receptor T Cells (CAR-T)Drug
After two cycles of glofitamab-based salvage therapy, single-target or dual-target CAR-T cells directed against CD19, CD20, and/or CD22 are infused following lymphodepleting (fludarabine + cyclophosphamide) or myeloablative conditioning, at a dose of 2-4 × 10⁶/kg.
| Study group | Role | What they receive |
|---|---|---|
| Glofitamab-based therapy followed by CAR-T ± ASCT | Experimental | Subjects will receive two cycles of glofitamab-based therapy, followed by either CAR-T cell therapy alone or in combination with ASCT. Receives: Drug: Glofitamab; Drug: Chimeric Antigen Receptor T Cells (CAR-T) |
What is being measured
The primary outcome is the main question the study is designed to answer.
complete response rate after CAR-T±ASCT
The complete response (CR) rate after CAR-T±ASCT is defined as the proportion of subjects achieving CR following CAR-T with or without ASCT.
Measured: From CAR-T±ASCT administration until 1 year post-treatment
Secondary outcomes (5)
overall response rate after CAR-T±ASCT
The overall response rate (ORR) after CAR-T±ASCT is defined as the proportion of subjects achieving CR or partial response (PR) following CAR-T with or without ASCT.
Measured: From CAR-T±ASCT administration until 1 year post-treatment
complete response rate before CAR-T±ASCT
The complete response rate before CAR-T±ASCT is defined as the proportion of subjects achieving CR on the last assessment before CAR-T ± ASCT.
Measured: From the initiation of glofitamab-based therapy until ≤14 days prior to the start of FC lymphodepleting therapy or myeloablative conditioning.
overall response rate before CAR-T±ASCT
The overall response rate (ORR) before CAR-T±ASCT is defined as the proportion of subjects achieving CR or PR on the last assessment before CAR-T ± ASCT.
Measured: From the initiation of glofitamab-based therapy until ≤14 days prior to the start of FC lymphodepleting therapy or myeloablative conditioning.
progression free survival-total (PFS-t）
PFS-t is measured from initiation of glofitamab-based therapy until disease progression, relapse, or death from any cause.
Measured: through 2 years after initiation of study treatment
progression free survival-CART (PFS-c）
PFS-c is measured from initiation of CAR-T±ASCT therapy until disease progression, relapse, or death from any cause.
Measured: through 2 years after initiation of study treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2025
- Study start9 May 2025
- Primary completion30 May 2027 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed or Refractory Aggressive B-cell 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dehui Zou, Principal investigator, Institute of Hematology & Blood Diseases Hospital, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06996132
- Sponsor's protocol ID
- IIT2025054
- Status last verified
- May 2025
- First submitted
- 20 May 2025
- Last updated
- 17 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Clinical Study of CD20×CD3 Bispecific Antibody-Based Salvage Therapy Followed by CAR-T With or Without ASCT in R/R Aggressive B-Cell Lymphoma
- ClinicalTrials.gov ID
- NCT06996132
- Acronym / sponsor ID
- IIT2025054
- Keywords
- Glofitamab, CAR T-cell therapy, autologous stem cell transplantation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Institute of Hematology & Blood Diseases Hospital, ChinaUniversity, hospital or other
- Study start
- 9 May 2025 (actual)
- Primary completion
- 30 May 2027 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 30 May 2025 (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.
This study consists of two sequential treatment phases. In the first phase, patients with r/r aggressive B-NHL receive two cycles of glofitamab ± investigator-selected agents. In the second phase, patients eligible for CAR-T monotherapy undergo FC lymphodepletion followed by CAR-T infusion (2-4×10⁶/kg), while those eligible for CAR-T+ASCT receive conditioning chemotherapy with PBSC reinfusion on day 0 and CAR-T administration (2-4×10⁶/kg) on day +3 (±1). Patients demonstrating Deauville 4-5 or ctDNA positivity at day 28 post-CAR-T infusion subsequently receive four cycles of glofitamab consolidation therapy.
Detailed description
The study comprises two sequential treatment phases. In the first phase, eligible patients with r/r aggressive B-NHL receive 2 cycles of glofitamab ± X regimen (where X includes but is not limited to chemotherapy, antibody-drug conjugates, or small-molecule targeted agents, selected at the investigator's discretion). Peripheral blood lymphocyte apheresis is performed prior to initial glofitamab administration unless clinically contraindicated, with hematopoietic stem cell mobilization and collection timed per investigator assessment to achieve minimum required yields of ≥3×10⁸/kg mononuclear cells and ≥2×10⁶/kg CD34+ cells.
Patients successfully completing phase 1 proceed to phase 2 treatment. In the CAR-T alone cohort, patients receive FC lymphodepleting therapy (days -5 to -3) followed by CAR-T cell infusion (2-4×10⁶/kg) on day 0. The CAR-T+ASCT cohort undergoes conditioning chemotherapy (regimen determined by investigator) with autologous PBSC reinfusion on day 0 and CAR-T cells (2-4×10⁶/kg) administered on day +3 (±1 day).
At day 28 post-CAR-T infusion, patients demonstrating PET-CT Deauville scores of 4-5 or ctDNA positivity initiate 4 cycles of glofitamab consolidation therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Glofitamab-based therapy followed by CAR-T ± ASCT | Experimental | Drug: Glofitamab, Drug: Chimeric Antigen Receptor T Cells (CAR-T)Subjects will receive two cycles of glofitamab-based therapy, followed by either CAR-T cell therapy alone or in combination with ASCT. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (24 listed)
- Patients with relapsed/refractory aggressive B-cell lymphoma, including the following subtypes: diffuse large B-cell lymphoma (DLBCL), high-grade B-cell lymphoma (HGBL), or transformed large B-cell lymphoma.
- Relapsed or refractory disease, meeting criteria for one of the following cohorts:
- Age ≥18 years and ≤65 years.
- Eastern Cooperative Oncology Group (ECOG) performance status ≤2.
- Hematologic parameters at screening must meet the following (unless due to bone marrow involvement):
Key exclusion criteria (13 listed)
- Confirmed primary central nervous system lymphoma;
- Prior autologous or allogeneic hematopoietic stem cell transplantation;
- Active HBV or HCV infection, defined as HBV-DNA or HCV-RNA levels above the upper limit of detection.
- Uncontrolled comorbidities include infectious diseases, cardiovascular/cerebrovascular disorders, coagulopathies, and connective tissue diseases.
- History of epilepsy or other central nervous system disorders;
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 |
|---|---|---|
| GlofitamabGlofitamab is administered as monotherapy or in combination with investigator-selected agents (including but not limited to chemotherapy, ADCs, BTK inhibitors, etc.) for 2 cycles. | Drug | Glofitamab-based therapy followed by CAR-T ± ASCT |
| Chimeric Antigen Receptor T Cells (CAR-T)After two cycles of glofitamab-based salvage therapy, single-target or dual-target CAR-T cells directed against CD19, CD20, and/or CD22 are infused following lymphodepleting (fludarabine + cyclophosphamide) or myeloablative conditioning, at a dose of 2-4 × 10⁶/kg. | Drug | Glofitamab-based therapy followed by CAR-T ± ASCT |
Primary outcome
complete response rate after CAR-T±ASCT
Time frame: From CAR-T±ASCT administration until 1 year post-treatment
The complete response (CR) rate after CAR-T±ASCT is defined as the proportion of subjects achieving CR following CAR-T with or without ASCT.
5 secondary outcomes
overall response rate after CAR-T±ASCT
Time frame: From CAR-T±ASCT administration until 1 year post-treatment
complete response rate before CAR-T±ASCT
Time frame: From the initiation of glofitamab-based therapy until ≤14 days prior to the start of FC lymphodepleting therapy or myeloablative conditioning.
overall response rate before CAR-T±ASCT
Time frame: From the initiation of glofitamab-based therapy until ≤14 days prior to the start of FC lymphodepleting therapy or myeloablative conditioning.
progression free survival-total (PFS-t）
Time frame: through 2 years after initiation of study treatment
progression free survival-CART (PFS-c）
Time frame: through 2 years after initiation of study 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 17 Jun 2025.
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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.
Dehui Zou principal investigator
Institute of Hematology & Blood Diseases Hospital, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Glofitamab and Chimeric Antigen Receptor T Cells (CAR-T) in people with Relapsed or Refractory Aggressive B-cell 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 24 inclusion and 13 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 17 Jun 2025. 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 phase mean?
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 WEI LIU (86-022-23608461, liuwei@ihcams.ac.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
complete response rate after CAR-T±ASCT (time frame: From CAR-T±ASCT administration until 1 year post-treatment). 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 17 Jun 2025.