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Emapalumab Prevention of CAR-T Cell Associated Toxicities

ConditionsLarge B-cell LymphomaRelapsed Non-Hodgkin LymphomaRefractory Non-Hodgkin LymphomaDiffuse Large B Cell LymphomaPrimary Mediastinal Large B-cell LymphomaHigh-grade B-cell LymphomaFollicular Lymphoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMarcela V. Maus, M.D.,Ph.D.

About this trial

This research study involves assessing the impact of emapalumab as preventative management of CAR-T related cytokine release syndrome in participants with Non-Hodgkin's lymphoma (NHL).

The research study involves the following study interventions:

* Fludarabine and cyclophosphamide (Lymphodepleting Chemotherapy) * Axicabtagene Ciloleucel or Lisocabtagene Maraleucel * Emapalumab

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adult patients with large B-cell lymphoma that is refractory to first-line chemoimmunotherapy or that relapses within 12 months of first-line chemoimmunotherapy. Or adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primary mediastinal large B-cell lymphoma, high grade B-cell lymphoma, and DLBCL arising from follicular lymphoma.

At least 1 measurable lesion per Lugano at time of screening.

Age 18 or older

Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.

Disqualifiers

History of malignancy other than nonmelanoma skin cancer or carcinoma in situ (e.g. cervix, bladder, breast) or follicular lymphoma unless disease free for at least 3 years.

Autologous stem cell transplant within 6 weeks of planned CAR-T infusion.

History of allogeneic stem cell transplantation.

Presence of uncontrolled fungal, bacterial, viral, or other infection at time of screening.

Trial design

Design model

Single group

Treatments tested in this trial

  • Emapalumab

    Drug

    An interferon gamma (IFNγ) blocking antibody

  • Cyclophosphamide

    Drug

    Alkylating agent

  • Fludarabine Phosphate

    Drug

    Purine antagonist antimetabolite

  • Axicabtagene Ciloleucel

    Drug

    Autologous treatment

  • Dexamethasone

    Drug

    Corticosteroid

  • Lisocabtagene maraleucel

    Drug

    Autologous treatment

Treatment groups

28 Participants
are divided into 4 treatment groups
Group A: Cohort 1aExperimental treatment 4 interventions
Group B: Cohort 1bExperimental treatment 5 interventions
Group C: Cohort 2aExperimental treatment 4 interventions
Group D: Cohort 2bExperimental treatment 5 interventions

Trial outcomes

Primary outcomes

1

Incidence of grade 2+ CRS per ASTCT

Assessed using American Society for Transplantation and Cellular Therapy (ASTCT). All participants will be monitored and assessed for grade 2+ cytokine release syndrome (CRS) for 24 months after post treatment.

Time frame
Day -1 to 24 months post treatment

Secondary outcomes

1

Rate and severity of ICANS as per ASTCT

Assessed using American Society for Transplantation and Cellular Therapy (ASTCT). The rate and severity of immune cell associated neurotoxicity syndrome (ICANS) within the first 30 days of infusion.

Time frame
30 days
2

Objective response rate (ORR)

The incidence of either a complete response or a partial response by Lugano. All subjects that do not meet the criteria for an objective response by the analysis data cutoff date will be considered non-responders.

Time frame
Day -1 to 24 months post treatment

Other outcomes

1

Duration of response (DOR)

Among subject who experience an objective response the date of their first objective response to disease progression per Lugano or death regardless of cause. Subjects not meeting the criteria for progression or death by the analysis data cutoff date will be censored at their last evaluable disease assessment date and their response will be noted as ongoing.

Time frame
From First Objective Response until date of first documented disease progression or date of death from any cause, assessed up to 24 months post treatment
2

Progression-free Survival (PFS)

The time from the CAR-T infusion date to the date of disease progression per Lugano or death from any cause. Subjects not meeting the criteria for progression by the analysis data cutoff date will be censored at their last evaluable disease assessment date.

Time frame
From Day 0 until date of first documented disease progression or date of death from any cause, assessed up to 24 months post treatment
3

Overall survival (OS)

The time from CAR-T infusion to the date of death. Subjects who have not died by the analysis data cutoff date will be censored at their last contact date.

Time frame
From Day 0 until documented date of death from any cause, assessed up to 24 months post treatment

Sponsors and contacts

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

Marcela V. Maus, M.D.,Ph.D.

Lead sponsor

Massachusetts General Hospital

Sponsor institution

Swedish Orphan Biovitrum

Collaborator

Source ClinicalTrials.gov
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