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Trial Title:
CAR T-cell Therapy in Combination With Glofitamab for Relapsed/Refractory Large B-Cell Lymphoma With High-Risk Prognostic Factors
NCT ID:
NCT06567366
Condition:
Large B-cell Lymphoma
Conditions: Official terms:
Lymphoma
Lymphoma, B-Cell
Obinutuzumab
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Biological
Intervention name:
CAR T-cell therapy
Description:
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).
Arm group label:
CAR T-cell therapy in combination with Glofitamab
Intervention type:
Drug
Intervention name:
Glofitamab
Description:
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).
Arm group label:
CAR T-cell therapy in combination with Glofitamab
Intervention type:
Drug
Intervention name:
Obinutuzumab
Description:
Obinutuzumab pre-treatment is given intravenously at a dose of 1g on Cycle 1 Day 1.
Arm group label:
CAR T-cell therapy in combination with Glofitamab
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.
Criteria for eligibility:
Criteria:
Key Inclusion Criteria:
- 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
Key Exclusion Criteria:
- 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
- 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Shanghai Ruijin Hospital
Address:
City:
Shanghai
Country:
China
Start date:
September 2024
Completion date:
September 2027
Lead sponsor:
Agency:
Ruijin Hospital
Agency class:
Other
Source:
Ruijin Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06567366
