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NCT Number: NCT06567366

CAR T-cell Therapy in Combination With Glofitamab for 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.

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Key information

Conditions

Large B-cell Lymphoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Shanghai Ruijin Hospital

Shanghai, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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).

Glofitamab

Drug

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).

Obinutuzumab

Drug

Obinutuzumab pre-treatment is given intravenously at a dose of 1g on Cycle 1 Day 1.

Primary outcomes

  1. 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

Secondary outcomes

  1. Objective Response Rate (ORR)

    Time frame: Up to 2 years

    ORR is defined as the percentage of participants achieving either CR or partial response (PR) per the Lugano Classification as determined by study investigators

  2. Duration of Response (DoR)

    Time frame: Up to 2 years

    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.

  3. Progression-Free Survival (PFS)

    Time frame: Up to 2 years

    PFS is defined as the time from leukapheresis to first documented progression or death from any cause.

  4. Overall Survival (OS)

    Time frame: Up to 2 years

    OS is defined as the time from leukapheresis to death from any cause.

  5. Percentage of Participants With Treatment Emergent Adverse Events (TEAEs)

    Time frame: Up to 2 years

    Assessed by CTCAE criteria v5 and ASTCT 2019 criteria for CRS/ICANS adverse events.

Study contacts

Contact information is provided by the study sponsor or research team.

Weili Zhao

CONTACT

[email protected]

008602164370045

Sponsors and collaborators

Lead sponsor

Ruijin Hospital

Other

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Aug 22, 2024
Registry last updated
Aug 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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