CAR T-cell Therapy in Combination With Glofitamab for Rel... | NCT06567366

NCT06567366

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

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No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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.	Biological: CAR T-cell therapy Drug: Glofitamab Drug: Obinutuzumab

Interventions

Name	Type	Description	Arm Group Labels	Other Names
CAR T-cell therapy	Biological	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).

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Complete Response (CR) Rate	CR rate is defined as the percentage of participants achieving CR per the Lugano Classification as determined by study investigators	Up to 2 years

Secondary Outcomes

Measure	Description	Time Frame
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	Up to 2 years
Duration of Response (DoR)

Eligibility Module

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