Sonrotoclax Plus Zanubrutinib in Patients With Relapsed/Refractory Mantle Cell Lymphoma Planned for Standard of Care CAR-T Cell Therapy

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorCanadian Cancer Trials Group

About this trial

The purpose of this study is to evaluate the effects of adding two oral medications (sonrotoclax plus zanubrutinib) to standard of care chimeric antigen receptor (CAR-T) cell therapy in participants with mantle cell lymphoma.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Have histologically confirmed mantle cell lymphoma that is relapsed or refractory after at least one prior line of systemic therapy

Eligible for and planned to receive Health Canada approved CAR-T.

Have a formalin fixed paraffin embedded tumour tissue block available and must have provided informed consent for the release of the block.

Presence of radiologically documented disease.

Disqualifiers

• Participants on active anticancer therapy for other advanced or metastatic malignancies.

Concurrent treatment with other anti-cancer therapy

Serious illnesses or medical conditions which would not permit the participant to be managed according to the protocol.

Known hypersensitivity to the study drug(s) or their components.

Trial design

Design model

Single group

Treatments tested in this trial

  • Zanubrutinib

    Drug

    assigned at enrollment

  • Sonrotoclax

    Drug

    assigned at enrollment

  • CAR-T Cell Therapy

    Biological/Vaccine

    Standard of Care

Treatment groups

40 Participants
are divided into 1 treatment group
Group A: Zanubrutinib + SonrotoclaxExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Complete response post CAR-T

Time frame
3.5 years

Secondary outcomes

1

Objective Response Rate assessed by the Lugano Classification

Time frame
3.5 years
2

1 year Progression-Free Survival

Time frame
4 years
3

Overall Survival

Time frame
4 years
4

Number and Severity of Adverse Events

Time frame
3.5 years

Other outcomes

Sponsors and contacts

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

Canadian Cancer Trials Group

Lead sponsor

BeOne Medicines

Collaborator