CAR T-cell Therapy in Combination With Glofitamab for Relapsed/Refractory Large B-Cell Lymphoma With High-Risk Prognostic Factors

Phase 2

Not yet recruiting

• Conditions: Large B-cell Lymphoma

• Registration Number: NCT06567366
• Lead Sponsor: Ruijin Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-8-20
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Not yet recruiting
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

Key Inclusion Criteria:<br><br> - Signed Informed Consent Form<br><br> - Histologically confirmed large B-cell lymphoma with CD19 and CD20 expression,<br> including diffuse large B-cell lymphoma (DLBCL) not otherwise specified (NOS);<br> primary mediastinal large B-cell lymphoma (PMBCL); high-grade B-cell lymphoma<br> (HGBL); and transformed follicular lymphoma<br><br> - Patients who have relapsed or are refractory to at least prior first-line therapy,<br> including anthracycline-containing chemotherapy regimens and anti-CD20 monoclonal<br> antibody therapy<br><br> - Patients must be willing to receive CAR-T and Glofitamab therapy and be deemed<br> suitable for CAR-T and Glofitamab treatment by the investigator<br><br> - Presence of at least one high-risk prognostic factor: (1) extranodal involvement;<br> (2) maximum tumor diameter > 4 cm; (3) TP53 mutation<br><br> - ECOG Performance Status of 0, 1, or 2<br><br> - Life expectancy =12 weeks<br><br> - Adequate hematologic function (unless due to underlying disease, such as extensive<br> bone marrow involvement, or secondary to lymphoma-related splenomegaly as determined<br> by the investigator, but transfusion of blood products is allowed) and adequate<br> liver, renal, pulmonary, and cardiac function<br><br>Key Exclusion Criteria:<br><br> - Hypersensitivity to any study drug or excipient<br><br> - History of allogeneic stem cell transplantation<br><br> - Patients with active viral hepatitis requiring treatment as determined by the<br> investigator: chronic hepatitis B virus carriers with HBV DNA = 500 IU/mL (2500<br> copies/mL) (HBV DNA testing only for patients who test positive for hepatitis B<br> surface antigen or core antibody); patients who test positive for HCV RNA (HCV<br> testing only for patients who test positive for HCV antibody)<br><br> - Presence of uncontrolled infection, cardio-cerebrovascular disease, coagulopathy, or<br> autoimmune disease, etc<br><br> - History of HIV infection<br><br> - Presence or concurrence of other malignancies within the past 2 years, with the<br> exception of cured cervical carcinoma in situ, non-melanoma skin cancer and<br> superficial bladder tumors<br><br> - Previous anti-CD19 CAR-T therapy is not allowed<br><br> - Pregnant or lactating women<br><br> - Other uncontrollable medical condition that may interfere the participation of the<br> study

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Complete Response (CR) Rate

Secondary Outcome Measures

Name	Time	Method
Objective Response Rate (ORR);Duration of Response (DoR);Progression-Free Survival (PFS);Overall Survival (OS);Percentage of Participants With Treatment Emergent Adverse Events (TEAEs)