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Clinical Trials/NCT07283679
NCT07283679
Not yet recruiting
Phase 1

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

M.D. Anderson Cancer Center1 site in 1 country30 target enrollmentStarted: June 1, 2026Last updated:
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InterventionsONC-PluReceptor NK cells

Overview

Phase
Phase 1
Status
Not yet recruiting
Enrollment
30
Locations
1
Primary Endpoint
Safety and Adverse Events (AEs)
OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Overview

Brief Summary

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.

Detailed Description

Primary Objective:

To establish the safety and recommended phase II dose (RP2D) of umbilical cord blood (CB)- derived natural killer (NK) cells transduced with ONC-PluReceptor (CD3 complex/IL-15) in combination with epcoritamab and tafasitamab for patients with relapsed/refractory (R/R) CD19/CD20-positive B-cell non-Hodgkin lymphomas.

Secondary Objectives:

  1. To evaluate the overall response rate (ORR), complete response (CR) rate and partial response (PR) rate of patients treated at the RP2D.
  2. To evaluate the duration of response (DOR).
  3. To evaluate the progression-free survival (PFS) rate.
  4. To evaluate the overall survival (OS) time.
  5. To quantify the persistence of infused donor NK cells in the recipient.
  6. To conduct comprehensive immune reconstitution studies.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Patients with R/R DLBCL or FL with all of the following:
  • •Failure of \>/= 2 prior lines of therapy, or an autologous or allogeneic stem cell transplant.
  • •Prior failure of CAR-T or not eligible for CAR-T cells.
  • •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/mm
  • •Serum creatinine clearance (CrCl) \>/=30 ml/min, estimated using the Cockcroft-Gault equation:
  • •Estimated creatinine clearance = (140-age \[years\]) x weight (kg) (x Fa) / serum creatinine (mg/dL) x 72 \[a where F=0.85 for females and F=1 for males\].
  • •Adequate hepatic function (ALT and/or AST \</=3 x upper limit of normal (ULN); bilirubin and ALP \</=2 x ULN). Patients with cancer involvement of the liver and elevation of ALT, AST, bilirubin, and/or ALP \</= 5 x ULN are eligible, per PI discretion.

Exclusion Criteria

  • •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.
  • •Grade \>/= 3 non-hematologic toxicity from prior therapy that has not improved to grade \</=
  • •Active hepatitis B, either active carrier (HBsAg +) or viremic (HBV DNA.\>/=10,000 copies/mL, or \>/=2,000 IU/mL), or hepatitis C (detectable viral load by HCV RNA PCR)
  • •Active infection requiring parenteral antibiotics.
  • •HIV infection.
  • •Treatment within prior 2 weeks with any anti-cancer agent, investigational or approved.
  • •Active central nervous system (CNS) involvement (untreated parenchymal brain metastasis or positive cytology of cerebrospinal fluid).

Arms & Interventions

Cycle 2: Dose Escalation/ Dose Expansion Treatment with ONC-PluReceptor NK cells

Experimental

Intervention: ONC-PluReceptor NK cells (Drug)

ESC/EXP1_Cycle 1: Dose Escalation/ Dose Expansion Treatment with ONC-PluReceptor NK cells

Experimental

Intervention: ONC-PluReceptor NK cells (Drug)

Outcomes

Primary Outcomes

Safety and Adverse Events (AEs)

Time Frame: Through study completion; an average of 1 year.

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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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