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Recruiting
NCT07283679
Trial of ONC-PluReceptor NK Cells With Epcoritamab and Tafasitamab for Patients With Recurrent or Refractory B-cell Non-Hodgkin Lymphoma
Conditions: Recurrent B-Cell Non-Hodgkin Lymphoma, Refractory B-cell Non-Hodgkin Lymphoma
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE1, PHASE2
Enrollment: 30
Sponsor: M.D. Anderson Cancer Center
Location: The University of Texas M. D. Anderson Cancer Center Houston Texas
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.
Eligibility Criteria
Inclusion Criteria:
1. 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.
2. Tumor biopsy positive for CD19 or CD20 at \>/= 1% by immunohistochemistry or flow cytometry.
3. Age 18-80 years.
4. Karnofsky performance status \>/=60%.
5. Absolute neutrophil count \>/=500/mm3 and platelet count \>/=50,000/mm3.
6. 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 \[a where F=0.85 for females and F=1 for males\].
7. Adequate hepatic function (ALT and/or AST \/=2,000 IU/mL), or hepatitis C (detectable viral load by HCV RNA PCR)
7. Active infection requiring parenteral antibiotics.
8. HIV infection.
9. Treatment within prior 2 weeks with any anti-cancer agent, investigational or approved.
10. Active central nervous system (CNS) involvement (untreated parenchymal brain metastasis or positive cytology of cerebrospinal fluid).
11. Life expectancy \
Source: ClinicalTrials.gov (NCT07283679). StuddyBuddy aggregates publicly available trial information.