Clinical trial NCT06567366: CAR T-cell Therapy in Combination With Glofitamab for Relapsed/Refractory Large B-Cell Lymphoma With High-Risk Prognostic Factors
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Large B-cell Lymphoma
Lead sponsor: Ruijin Hospital
Sponsor class: OTHER
First posted: 2024-08-22
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


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

Primary outcomes:
measure: Complete Response (CR) Rate
timeFrame: Up to 2 years
Secondary outcomes:
measure: Objective Response Rate (ORR)
timeFrame: Up to 2 years
measure: Duration of Response (DoR)
timeFrame: Up to 2 years
measure: Progression-Free Survival (PFS)
timeFrame: Up to 2 years
measure: Overall Survival (OS)
timeFrame: Up to 2 years
measure: Percentage of Participants With Treatment Emergent Adverse Events (TEAEs)
timeFrame: Up to 2 years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Ruijin Hospital
Study officials:
References: