Large B-cell LymphomaPhase 2NCT06567366
CAR T-cell Therapy in Combination With Glofitamab for Relapsed/Refractory Large B-Cell Lymphoma With High-Risk Prognostic Factors
A Phase 2 study testing CAR T-cell therapy, Glofitamab and Obinutuzumab in people with Large B-cell Lymphoma, run by Ruijin Hospital at 1 site in China.
Trial summary
The aim of this study is to evaluate the efficacy and safety of CAR T-cell therapy in combination with glofitamab for the treatment of relapsed/refractory large B-cell lymphoma with high-risk prognostic factors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Large B-cell Lymphoma
- What is being tested?
- CAR T-cell therapy, Glofitamab and Obinutuzumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteChina
- Study dates
- Sep 2024to Sep 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed Informed Consent Form
- Histologically confirmed large B-cell lymphoma with CD19 and CD20 expression, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified (NOS); primary mediastinal large B-cell lymphoma (PMBCL); high-grade B-cell lymphoma (HGBL); and transformed follicular lymphoma
- Patients who have relapsed or are refractory to at least prior first-line therapy, including anthracycline-containing chemotherapy regimens and anti-CD20 monoclonal antibody therapy
- Patients must be willing to receive CAR-T and Glofitamab therapy and be deemed suitable for CAR-T and Glofitamab treatment by the investigator
- Presence of at least one high-risk prognostic factor: (1) extranodal involvement; (2) maximum tumor diameter > 4 cm; (3) TP53 mutation
- ECOG Performance Status of 0, 1, or 2
- Life expectancy ≥12 weeks
- Adequate hematologic function (unless due to underlying disease, such as extensive bone marrow involvement, or secondary to lymphoma-related splenomegaly as determined by the investigator, but transfusion of blood products is allowed) and adequate liver, renal, pulmonary, and cardiac function
Who cannot join
- Hypersensitivity to any study drug or excipient
- History of allogeneic stem cell transplantation
- Patients with active viral hepatitis requiring treatment as determined by the investigator: chronic hepatitis B virus carriers with HBV DNA ≥ 500 IU/mL (2500 copies/mL) (HBV DNA testing only for patients who test positive for hepatitis B surface antigen or core antibody); patients who test positive for HCV RNA (HCV testing only for patients who test positive for HCV antibody)
- Presence of uncontrolled infection, cardio-cerebrovascular disease, coagulopathy, or autoimmune disease, etc
- History of HIV infection
- Presence or concurrence of other malignancies within the past 2 years, with the exception of cured cervical carcinoma in situ, non-melanoma skin cancer and superficial bladder tumors
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- Previous anti-CD19 CAR-T therapy is not allowed
- Pregnant or lactating women
- Other uncontrollable medical condition that may interfere the participation 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.
About this study
Official title: A Single-Center, Prospective Study Evaluating the Efficacy and Safety of CAR T-cell Therapy in Combination With Glofitamab in the Treatment of Relapsed/Refractory Large B-Cell Lymphoma With High-Risk Prognostic Factors
The aim of this study is to evaluate the efficacy and safety of CAR T-cell therapy in combination with glofitamab for the treatment of relapsed/refractory large B-cell lymphoma with high-risk prognostic factors.
- Conditions
- Large B-cell Lymphoma
- Being tested
- CAR T-cell therapy, Glofitamab, Obinutuzumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAR T-cell therapyBiological
Participants will receive CAR T-cell therapy via infusion on Day 0 (given as per treatment guidelines). Prior to CAR T-cell Therapy, participants will begin receiving lymphodepleting chemotherapy on Days -5 through -3 (given as per treatment guidelines).
GlofitamabDrug
Glofitamab is given intravenously at a dose of 2.5mg over 4 hours on Cycle 1 Day 8.
Glofitamab is given intravenously at a dose of 10mg over 2 hours on Cycle 1 Day 15.
Glofitamab is given intravenously at a dose of 30mg over 2 hours on Day 1 of Cycles 2-6 (as relevant).
ObinutuzumabDrug
Obinutuzumab pre-treatment is given intravenously at a dose of 1g on Cycle 1 Day 1.
| Study group | Role | What they receive |
|---|---|---|
| CAR T-cell therapy in combination with Glofitamab | Experimental | After undergoing leukapheresis, participants will receive treatment in the following procedure.
Bridging Phase:
All participants will receive two cycles of Glofitamab treatment. On Day 1 of Cycle 1, patients will receive 1000 mg of Obinutuzumab as pretreatment.
CAR-T Treatment Phase:
Participants will receive lymphodepletion therapy with the FLU/CY regimen on Day -5 through Day -3. Participants will receive the CAR T-cell infusion on Day 0.
Consolidation Phase:
Treatment based on the response assessment at Day 28 after CAR T-cell infusion: participants who attained complete response (CR) at Day 28 will not receive additional Glofitamab treatment, while those attained partial response (PR), stable disease (SD), or progressive disease (PD) will receive additional four cycles of Glofitamab. Receives: Biological: CAR T-cell therapy; Drug: Glofitamab; Drug: Obinutuzumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete Response (CR) Rate
CR rate is defined as the percentage of participants achieving CR per the Lugano Classification as determined by study investigators
Measured: Up to 2 years
Secondary outcomes (5)
Objective Response Rate (ORR)
ORR is defined as the percentage of participants achieving either CR or partial response (PR) per the Lugano Classification as determined by study investigators
Measured: Up to 2 years
Duration of Response (DoR)
DoR is defined only for participants who experience an objective response and is the time from the first objective response to disease progression or death from any cause.
Measured: Up to 2 years
Progression-Free Survival (PFS)
PFS is defined as the time from leukapheresis to first documented progression or death from any cause.
Measured: Up to 2 years
Overall Survival (OS)
OS is defined as the time from leukapheresis to death from any cause.
Measured: Up to 2 years
Percentage of Participants With Treatment Emergent Adverse Events (TEAEs)
Assessed by CTCAE criteria v5 and ASTCT 2019 criteria for CRS/ICANS adverse events.
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2024
- Study startSep 2024 (estimated)
- Primary completionSep 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Large B-cell LymphomaStudies of the same condition, open and under way.
- More trials run by Ruijin HospitalThe 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
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhao Weili, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06567366
- Sponsor's protocol ID
- Glofit-CART
- Status last verified
- Aug 2024
- First submitted
- 20 Aug 2024
- Last updated
- 22 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Center, Prospective Study Evaluating the Efficacy and Safety of CAR T-cell Therapy in Combination With Glofitamab in the Treatment of Relapsed/Refractory Large B-Cell Lymphoma With High-Risk Prognostic Factors
- ClinicalTrials.gov ID
- NCT06567366
- Acronym / sponsor ID
- Glofit-CART
- Conditions
- Large B-cell Lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- Sep 2024 (estimated)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 22 Aug 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 is to evaluate the efficacy and safety of CAR T-cell therapy in combination with glofitamab for the treatment of relapsed/refractory large B-cell lymphoma with high-risk prognostic factors.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CAR T-cell therapy in combination with Glofitamab | Experimental | Biological: CAR T-cell therapy, Drug: Glofitamab, Drug: ObinutuzumabAfter undergoing leukapheresis, participants will receive treatment in the following procedure. Bridging Phase: All participants will receive two cycles of Glofitamab treatment. On Day 1 of Cycle 1, patients will receive 1000 mg of Obinutuzumab as pretreatment. CAR-T Treatment Phase: Participants will receive lymphodepletion therapy with the FLU/CY regimen on Day -5 through Day -3. Participants will receive the CAR T-cell infusion on Day 0. Consolidation Phase: Treatment based on the response assessment at Day 28 after CAR T-cell infusion: participants who attained complete response (CR) at Day 28 will not receive additional Glofitamab treatment, while those attained partial response (PR), stable disease (SD), or progressive disease (PD) will receive additional four cycles of Glofitamab. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Signed Informed Consent Form
- Histologically confirmed large B-cell lymphoma with CD19 and CD20 expression, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified (NOS); primary mediastinal large B-cell lymphoma (PMBCL); high-grade B-cell lymphoma (HGBL); and transformed follicular lymphoma
- Patients who have relapsed or are refractory to at least prior first-line therapy, including anthracycline-containing chemotherapy regimens and anti-CD20 monoclonal antibody therapy
- Patients must be willing to receive CAR-T and Glofitamab therapy and be deemed suitable for CAR-T and Glofitamab treatment by the investigator
- Presence of at least one high-risk prognostic factor: (1) extranodal involvement; (2) maximum tumor diameter > 4 cm; (3) TP53 mutation
Key exclusion criteria (9 listed)
- Hypersensitivity to any study drug or excipient
- History of allogeneic stem cell transplantation
- Patients with active viral hepatitis requiring treatment as determined by the investigator: chronic hepatitis B virus carriers with HBV DNA ≥ 500 IU/mL (2500 copies/mL) (HBV DNA testing only for patients who test positive for hepatitis B surface antigen or core antibody); patients who test positive for HCV RNA (HCV testing only for patients who test positive for HCV antibody)
- Presence of uncontrolled infection, cardio-cerebrovascular disease, coagulopathy, or autoimmune disease, etc
- History of HIV infection
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 |
|---|---|---|
| CAR T-cell therapyParticipants will receive CAR T-cell therapy via infusion on Day 0 (given as per treatment guidelines). Prior to CAR T-cell Therapy, participants will begin receiving lymphodepleting chemotherapy on Days -5 through -3 (given as per treatment guidelines). | Biological | CAR T-cell therapy in combination with Glofitamab |
| GlofitamabGlofitamab is given intravenously at a dose of 2.5mg over 4 hours on Cycle 1 Day 8. Glofitamab is given intravenously at a dose of 10mg over 2 hours on Cycle 1 Day 15. Glofitamab is given intravenously at a dose of 30mg over 2 hours on Day 1 of Cycles 2-6 (as relevant). | Drug | CAR T-cell therapy in combination with Glofitamab |
| ObinutuzumabObinutuzumab pre-treatment is given intravenously at a dose of 1g on Cycle 1 Day 1. | Drug | CAR T-cell therapy in combination with Glofitamab |
Primary outcome
Complete Response (CR) Rate
Time frame: Up to 2 years
CR rate is defined as the percentage of participants achieving CR per the Lugano Classification as determined by study investigators
5 secondary outcomes
Objective Response Rate (ORR)
Time frame: Up to 2 years
Duration of Response (DoR)
Time frame: Up to 2 years
Progression-Free Survival (PFS)
Time frame: Up to 2 years
Overall Survival (OS)
Time frame: Up to 2 years
Percentage of Participants With Treatment Emergent Adverse Events (TEAEs)
Time frame: Up to 2 years
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 22 Aug 2024.
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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.
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 CAR T-cell therapy, Glofitamab and Obinutuzumab in people with Large B-cell Lymphoma, run by Ruijin 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 8 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: opening soon, as of the sponsor's last update on 22 Aug 2024. 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 Weili Zhao (008602164370045, zwl_trial@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete Response (CR) Rate (time frame: Up to 2 years). 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 22 Aug 2024.