Trial of ONC-PluReceptor NK Cells With Epcoritamab and Tafasitamab for Patients With Recurrent or Refractory B-cell Non-Hodgkin Lymphoma (NCT07283679)

🧪 Interventions in This Study

• ONC-PluReceptor NK cells (DRUG)

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

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 \</=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.
8. Adequate pulmonary function with FEV1, FVC and DLCO (corrected for hemoglobin and volume) \>/=50%.
9. Adequate cardiac function with left ventricular ejection fraction \>/=40%, and no uncontrolled arrhythmias or symptomatic cardiac disease.
10. If female of child-bearing potential, she must not be pregnant or breastfeeding and required to have a negative urine or serum pregnancy test prior to enrollment.
11. Female participants of non-childbearing potential must meet at least one of the following criteria: i. Postmenopausal (no menses in greater than or equal to 12 consecutive months). ii. History of hysterectomy or bilateral salpingo-oophorectomy. iii. Ovarian failure (Follicle Stimulating Hormone and Estradiol in menopausal range, who have received Whole Pelvic Radiation Therapy). o Subjects who are of childbearing potential, sexually active, and at risk of pregnancy must agree to use a highly effective method of contraception for the duration of the active treatment and at least 3 months post-completion of the study therapy. See Appendix B. Highly effective methods of contraception include the following: iv. Hormonal contraception (i.e., birth control pills, injection, implant, transdermal patch, vaginal ring), Intrauterine device (IUD), Tubal Ligation or hysterectomy, Subject/Partner post vasectomy, Implantable or injectable contraceptives, and condoms plus spermicide. Not engaging in sexual activity for the total duration of the trial and the drug washout period is an acceptable practice; however periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of birth control. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. o Men treated or enrolled in this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of study agent administration. Men who are able to have children must use effective birth control while in the study. If the male participant fathers a child or suspects that he has fathered a child while in the study, he must immediately notify his doctor.
12. Agree to sign the consent to the long-term follow-up protocol PA17-0843 to fulfill the institutional responsibilities to various regulatory agencies

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (1 Sites)

• The University of Texas M. D. Anderson Cancer Center — Houston, Texas

📞 Contact the Study Coordinator

Phone: (713) 794-1752

Email: ynieto@mdanderson.org

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

💰 Cost, Insurance & Patient Rights

• 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
• Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
• Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

More studies in Recurrent B-Cell Non-Hodgkin Lymphoma

• Testing the Combination of Nivolumab and ASTX727 for Relapsed or Refractory B-Cell Lymphoma — Birmingham, Alabama
• Epcoritamab and Lenalidomide in Treating Patients With Refractory or Relapsed Immunodeficiency-Related Large B-Cell Lymphoma — Chicago, Illinois
• A Phase I/II Study to Evaluate the Safety of Cellular Immunotherapy Using Autologous T Cells Engineered to Express a CD20-Specific Chimeric Antigen Receptor for Patients With Relapsed or Refractory B Cell Non-Hodgkin Lymphomas — Seattle, Washington
• Testing the Safety of the Anti-cancer Drugs Tazemetostat and Belinostat in Patients With Lymphomas That Have Resisted Treatment — Sacramento, California
• A Cognitive Training Intervention for Improving Cognitive and Neurological Outcomes in Patients Undergoing Treatment for Relapsed or Refractory Multiple Myeloma or B-cell Non-Hodgkin Lymphoma — Columbus, Ohio

Explore by condition: All Recurrent B-Cell Non-Hodgkin Lymphoma clinical trials

💡 How to Participate

1. Check the checklist above to see if you may qualify.
2. Contact the study coordinator using the phone/email above.
3. Ask about the visit schedule, what is covered at no cost, and any travel support.
4. Confirm with your own doctor before making a decision.