CD19-Directed CAR-T Cell Therapy for the Treatment of Relapsed/Refractory B Cell Malignancies (NCT04892277)

🧪 Interventions in This Study

• Autologous Anti-CD19 CAR-expressing T-lymphocytes IC19/1563 (BIOLOGICAL)
• Bendamustine (DRUG)
• Cyclophosphamide (DRUG)
• Fludarabine (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. Age \>= 18 years
2. Relapsed or refractory CD19+ B cell malignancies of the one of the following histopathology:
3. Biopsy proven B-cell non-Hodgkin lymphoma (NHL) of any histopathology (including Richter Transformation of CLL); relapsed or refractory disease defined as:
4. Two or more prior lines of therapy, at least one anthracycline containing regimen, unless intolerable. Exception: Patients with Richter transformation of CLL are eligible if they had \>= one prior treatment, including prior BTK inhibition
5. Demonstration of progressive or stable disease by positron emission tomography/computed tomography (PET/CT) or CT criteria as the best response to the most recent chemotherapy regimen according to the revised Lugano Response Criteria for Malignant Lymphoma.
6. Measurable disease defined as measurable by CT portion of a PET/CT: To be considered measurable, the must be at least one lesion that has a single diameter of (\>1.5 cm Note: Lesions that have been previously irradiated will be considered measurable only if progression has been documented following completion of radiation therapy
7. Biopsy proven SLL or flow cytometry proven CLL; relapsed disease defined as:
8. \>= two prior lines of therapy, and/or \>= 6 months of second line prior BTK inhibition (e.g. venetoclax and ibrutinib). Exception: Patients in stable disease (SD) or partial response (PR) with a known ibrutinib resistance mutation (BTK or phospholipase Cgamma2) may be included even if on ibrutinib therapy for less than 6 months.
9. Demonstration of progressive or stable disease by PET/CT or CT criteria according to the International Workshop on Chronic Lymphocytic Leukemia (iwCLL2018) criteria
10. Measurable disease by CT portion of a PET/CT where at least one lesion has a single diameter of \>1.5 cm or peripheral blood absolute blood lymphocyte count (ALC) of \> 5000. Note: Lesions that have been previously irradiated will be considered measurable only if progression has been documented following completion of radiation therapy
11. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1
12. Hemoglobin \>= 8.0 g/dL (=\< 14 days prior to registration)

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

📍 All Participating Trial Locations (1 Sites)

• Mayo Clinic in Rochester — Rochester, Minnesota

📞 Contact the Study Coordinator

Phone: (855) 776-0015

Email: mayocliniccancerstudies@mayo.edu

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

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• 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.