Trial of ONC-PluReceptor NK Cells With Epcoritamab and Tafasitamab for Patients With Recurrent or Refractory B-cell Non-Hodgkin Lymphoma

Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorM.D. Anderson Cancer Center

About this trial

The goal of this clinical research study is to learn if ONC-PluReceptor NK cell therapy (combined with the monoclonal antibody therapies epcoritamab and tafasitamab) can help to control relapsed or refractory B-cell Non-Hodgkin Lymphoma. The safety of this treatment will also be studied.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Tumor biopsy positive for CD19 or CD20 at >/= 1% by immunohistochemistry or flow cytometry.

Age 18-80 years.

Karnofsky performance status >/=60%.

Absolute neutrophil count >/=500/mm3 and platelet count >/=50,000/mm3.

Disqualifiers

Lymphoma in CR with no measurable sites of disease.

Major surgery <4 weeks prior to first dose of study drug.

Any other severe or uncontrolled disease or condition that might increase the risk associated with study participation.

Any other malignancy known to be active, with the exception of treated cervical intra-epithelial neoplasia and non-melanoma skin cancer.

Trial design

Design model

Single group

Treatments tested in this trial

  • ONC-PluReceptor NK cells

    Drug

    Given by injection

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: Cycle 2: Dose Escalation/ Dose Expansion Treatment with ONC-PluReceptor NK cellsExperimental treatment 1 intervention
Group B: ESC/EXP1_Cycle 1: Dose Escalation/ Dose Expansion Treatment with ONC-PluReceptor NK cellsExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Safety and Adverse Events (AEs)

Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0

Time frame
Through study completion; an average of 1 year.

Secondary outcomes

Other outcomes

Sponsors and contacts

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