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Loncastuximab Tesirine and Mosunetuzumab for the Treatment of Relapsed or Refractory Diffuse Large B-Cell Lymphoma

ConditionsRecurrent Diffuse Large B-Cell LymphomaRecurrent Grade 3b Follicular LymphomaRecurrent High Grade B-Cell LymphomaRecurrent Primary Mediastinal (Thymic) Large B-Cell LymphomaRecurrent Transformed Chronic Lymphocytic LeukemiaRecurrent Transformed Indolent B-Cell Non-Hodgkin Lymphoma to Diffuse Large B-Cell LymphomaRefractory Diffuse Large B-Cell LymphomaRefractory Grade 3b Follicular LymphomaRefractory High Grade B-Cell LymphomaRefractory Primary Mediastinal (Thymic) Large B-Cell LymphomaRefractory Transformed Chronic Lymphocytic LeukemiaRefractory Transformed Indolent B-Cell Non-Hodgkin Lymphoma to Diffuse Large B-Cell Lymphoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorCity of Hope Medical Center

About this trial

This phase II trial studies the safety and how well of loncastuximab tesirine when given together with mosunetuzumab works in treating patients with diffuse large B-cell lymphoma that has come back (relapsed) or does not respond to treatment (refractory). Loncastuximab tesirine is a monoclonal antibody, loncastuximab, linked to a toxic agent called tesirine. Loncastuximab attaches to anti-CD19 cancer cells in a targeted way and delivers tesirine to kill them. Mosunetuzumab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Giving loncastuximab tesirine with mosunetuzumab may help treat patients with relapsed or refractory diffuse large B-cell lymphoma.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Documented informed consent of the participant and/or legally authorized representative.

Assent, when appropriate, will be obtained per institutional guidelines.

Be willing to provide tissue from a fresh core or excisional biopsy (performed as standard of care) of a tumor lesion prior to starting study therapy or from diagnostic tumor biopsies.

If unavailable, exceptions may be granted with study principal investigator (PI) approval.

Disqualifiers

Prior treatment with loncastuximab tesirine.

Prior treatment with mosunetuzumab or other CD20-directed bispecific antibodies.

Prior allogeneic stem cell transplantation.

Prior use of any monoclonal antibody, radioimmunoconjugate or ADC within 2 weeks prior to Day 1 of protocol therapy.

Trial design

Design model

Single group

Treatments tested in this trial

  • Biopsy

    Procedure/Surgery

    Undergo biopsy

  • Biospecimen Collection

    Procedure/Surgery

    Undergo collection of blood samples

  • Computed Tomography

    Procedure/Surgery

    Undergo PET/CT

  • Loncastuximab Tesirine

    Biological/Vaccine

    Given IV

  • Mosunetuzumab

    Biological/Vaccine

    Given IV

  • Positron Emission Tomography

    Procedure/Surgery

    Undergo PET/CT

Treatment groups

36 Participants
are divided into 1 treatment group
Group A: Treatment (oncastuximab tesirine, mosunetuzumab)Experimental treatment 6 interventions

Trial outcomes

Primary outcomes

1

Unacceptable toxicity (Safety Lead-in)

Defined as any toxicity occurring during the first cycle of treatment for patients enrolled on DL 1, or during the first two cycles of treatment for patients enrolled on DL -1, within at most one out of six patients treated. Will be conducted per the rolling six design.

Time frame
Up to 30 days post-last dose of protocol therapy
2

Overall response rate (ORR) (Phase 2)

Defined as the proportion of response-evaluable participants that achieve a best response of either CR or PR. Will use a Simon's 2-stage Minimax design, occur within at most 26 responders. Will be estimated along with the 95% exact binomial confidence interval.

Time frame
Up to 2 years post-last dose

Secondary outcomes

1

Incidence of adverse events

Will be graded by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 and cytokine-release syndrome (CRS) will be graded according to the American Society for Transplantation and Cellular Therapy (ASTCT) CRS Consensus Grading Criteria.

Time frame
Up to 30 days post-last dose of protocol therapy
2

Complete response rate (CR) rate

Defined as the proportion of response-evaluable participants that achieve a best response of CR. Will be estimated along with the 95% exact binomial confidence interval.

Time frame
Up to 2 years post-last dose
3

Duration of response (DOR)

Will be estimated using the product-limit method of Kaplan and Meier along with the Greenwood estimator of standard error; 95% confidence interval will be constructed based on log-log transformation.

Time frame
Up to 2 years post-last dose
4

Progression-free survival (PFS)

Will be estimated using the product-limit method of Kaplan and Meier along with the Greenwood estimator of standard error; 95% confidence interval will be constructed based on log-log transformation.

Time frame
From start of protocol treatment to time of disease relapse/progression or death due to any cause, whichever occurs earlier, assessed up to 2 years post-last dose

Other outcomes

Sponsors and contacts

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

City of Hope Medical Center

Lead sponsor

National Cancer Institute (NCI)

Collaborator

Source ClinicalTrials.gov
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