Health TrialsbyHealthPanel

Glofitamab Combined With CAR-T Therapy in R/R DLBCL

ConditionDLBCL - Diffuse Large B Cell Lymphoma
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorRuijin Hospital

About this trial

This study is a single-center, open-label, prospective study aimed at evaluating the efficacy and safety of Glofitamab combined with CAR-T therapy in patients with high-risk relapsed/refractory large B-cell lymphoma.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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 DLBCL transformed from follicular lymphoma

Patients who have relapsed after at least one prior line of therapy or are refractory, including those who have received 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

Disqualifiers

History of allergic reactions to compounds with similar chemical or biological composition to axi==cel, relma==cel, glofitamab, obinutuzumab, or other drugs used in the study.

Active or uncontrolled infections requiring systemic therapy (including fungal, bacterial, viral, etc.)

History of allogeneic hematopoietic stem cell transplantation

History of organ transplantation

Trial design

Design model

Single group

Treatments tested in this trial

  • Glofitamab

    Drug

    Glofitamab IV infusion will be administered as per the schedule specified in the respective arm.

  • Obinutuzumab

    Drug

    Obinutuzumab IV infusion will be administered as per the schedule specified in the respective arm.

  • Axicabtagene Ciloleucel

    Drug

    Axicabtagene Ciloleucel IV infusion will be administered as per the schedule specified in the respective arm.

  • Relmacabtagene autoleucel (relma-cel)

    Drug

    Relmacabtagene autoleucel IV infusion will be administered as per the schedule specified in the respective arm.

Treatment groups

24 Participants
are divided into 1 treatment group
Group A: Glofit_CARTExperimental treatment 4 interventions

Trial outcomes

Primary outcomes

1

Complete Response Rate (CRR)

Assessed by Investigator per Lugano Response Criteria for Malignant Lymphoma

Time frame
Baseline up to the end of treatment (EOT) (approximately 4 months)

Secondary outcomes

1

Overall Response Rate (ORR)

Assessed by Investigator per Lugano Response Criteria for Malignant Lymphoma

Time frame
Baseline up to the EOT (approximately 4 months)
2

Duration of Response (DoR)

Time frame
From the date of the first occurrence of a documented CR or partial response (PR) to the date of progression, relapse, or death from any cause, whichever occurs first (up to approximately 42 months)
3

PFS

Assessed by Investigator per Lugano Response Criteria for Malignant Lymphoma

Time frame
From the start of treatment until the first occurrence of disease progression or relapse, or death from any cause, whichever occurs earlier (approximately 42 months)
4

Overall Survival (OS)

Time frame
From the start of treatment until the date of death from any cause (approximately 42 months)

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ruijin Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: