A Study to Evaluate GEN3013 in Patients with Relapsed, Progressive or Refractory B-Cell Lymphoma

Overview

About this study

The purpose of the trial is to determine the maximum tolerated dose and the recommended phase 2 dose as well as to establish the safety profile of GEN3013 (DuoBody®-CD3xCD20) in patients with Relapsed, Progressive or Refractory B-Cell Lymphoma.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Main Inclusion Criteria Escalation Part

- Documented CD20+ mature B-cell neoplasm

1. Diffuse large B-cell lymphoma - de novo or transformed

2. High-grade B-cell lymphoma

3. Primary mediastinal large B-cell lymphoma

4. Follicular lymphoma

5. Mantle cell lymphoma

6. Small lymphocytic lymphoma

7. Marginal zone lymphoma (nodal, extranodal or mucosa associated)

- Relapsed, progressive and/or refractory disease following treatment with an anti-CD20
monoclonal antibody (e.g. rituximab) potentially in combination with chemotherapy
and/or relapsed after autologous stem cell rescue.

- ECOG performance status 0,1 or 2

- Patients must have measurable disease by CT, MRI or PET-CT scan

- Acceptable renal function

- Acceptable liver function

Main Inclusion Criteria Expansion Part

- Documented CD20 positive mature B cell neoplasm or CD20+ MCL

- Diffuse large B cell lymphoma, de novo or transformed (including double hit or triple
hit)

- Primary mediastinal large B cell lymphoma

- Follicular lymphoma grade 3B

- Histologic confirmed follicular lymphoma

- Marginal zone lymphomas

- Small lymphocytic lymphoma

- Mantle Cell Lymphoma (prior BTKi or intolerant to BTKi)

- At least 2 therapies including an anti CD20 monoclonal antibody containing
chemotherapy combination regimen

- Either failed prior autologous hematopoietic stem cell transplantation or ineligible
for autologous stem cell transplantation due to age or comorbidities

- At least 1 measurable site of disease based on CT, MRI or PET-CT scan with involvement
of 2 or more clearly demarcated lesions and or nodes

NOTE: Other protocol defined Inclusion criteria may apply.

Eligibility last updated 9/29/22. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Allison Rosenthal, D.O.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publications

Publications are currently not available
.

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