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MB-105 in Patients With CD5 Positive T-cell Lymphoma

ConditionLymphoma, T-Cell
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMarch Biosciences Inc

About this trial

This is a single arm, two-stage, Phase 2, open-label, multicenter study of MB-105 in patients with CD5 Positive (CD5+) Relapsed / Refractory T-cell Lymphoma (r/r TCL). This study will apply a Simon two-stage optimal design.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Male or female ≥ 18 years of age.

Patients with r/r TCL per WHO 2022 criteria.

r/r CTCL that has failed ≥ 2 prior lines of standard of care (SoC) therapy.

r/r PTCL that has failed ≥ 1 prior lines of SoC therapy. Note: patients with CD30+ disease should have received brentuximab vedotin.

Disqualifiers

Sezary syndrome. For other tumor types, if there is a suspicion of significant circulating disease at time of leukapheresis, discuss eligibility with medical monitor prior to proceeding.

Contraindication to leukapheresis.

Prior treatment with any CD5-targeted therapy.

HIV infection.

Trial design

Design model

Single group

Treatments tested in this trial

  • Genetic: MB-105

    Biological/Vaccine

    MB-105 is a CAR T-cell therapy that consists of autologous T-cells that express a CD5 CAR.

Treatment groups

46 Participants
are divided into 1 treatment group
Group A: Single armOther 1 intervention

Trial outcomes

Primary outcomes

1

Adverse events (AEs) per Common Terminology Criteria for Adverse Events (CTCAE) version 5.0

Incidence, severity, causal relationship of AEs

Time frame
26 months
2

Objective response rate (ORR)

Best objective response rate (ORR) per independent central review as defined by rate of complete response (CR) and PR using the 2014 Lugano criteria and 2022 Global criteria.

Time frame
26 months

Secondary outcomes

1

Duration of response (DOR)

Duration of Response (DOR), defined as time from first observation of response to the time of disease progression or death, whichever comes first (per investigator and by central review).

Time frame
26 months
2

Progression-free survival (PFS)

Progression-free survival (PFS), defined as time from administration of MB-105 to the time of disease progression or death, whichever comes first (per investigator and by central review).

Time frame
26 months
3

Incidence of adverse events during the safety monitoring period for acute toxicities

* All AEs from leukapheresis up to Day 30. * Related AEs from MB-105 infusion to Day 90 (i.e. excluding only AEs that are clearly an expected event from underlying condition or non-study related treatment). * SAEs and all-cause mortality from MB-105 infusion to EOS at Month 24.

Time frame
26 months
4

Overall survival (OS)

Overall survival (OS), defined as time from administration of MB-105 to death.

Time frame
26 months

Other outcomes

Sponsors and contacts

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

March Biosciences Inc

Lead sponsor

Source ClinicalTrials.gov
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