CAR.CD19-CD28-zeta-2A-iCasp9-IL15-Transduced Cord Blood NK Cells, High-Dose Chemotherapy, and Stem Cell Transplant in Treating Participants With B-cell Lymphoma

Phase 1/2 Withdrawn M.D. Anderson Cancer Center National Cancer Institute (NCI) · collab

NaSingle-groupOpen-labelTreatment

Summary

This phase I/II trial studies the side effects and best dose of chimeric antigen receptor (CAR).CD19-CD28-zeta-2A-iCasp9-IL15-transduced cord blood NK cells when given together with high-dose chemotherapy and stem cell transplant and to see how well they work in treating participants with B-cell lymphoma. Cord blood-derived CAR-NK cells may react against the B-cell lymphoma cells in the body, which may help to control the disease. Giving chemotherapy before a stem cell transplant may help kill any cancer cells that are in the body and helps make room in the patient's bone marrow for new blood-forming cells (stem cells) to grow. The stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy.

Timeline

Start: 2019-10-03
Primary completion: 2019-10-03
Completion: 2019-10-03

Outcome

Outcome not reported

Stopped (Business): “Lack of Funding”

Publications

Ernst M, Oeser A, Besiroglu B, Caro-Valenzuela J, Abd El Aziz M, Monsef I, Borchmann P, Estcourt LJ, Skoetz N, Goldkuhle M. Chimeric antigen receptor (CAR) T-cell therapy for people with relapsed or refractory diffuse large B-cell lymphoma. Cochrane Database Syst Rev. 2021 Sep 13;9(9):CD013365. doi: 10.1002/14651858.CD013365.pub2.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Umbilical Cord Blood-derived Natural Killer Cells	Cell therapy	—	Intravenous
Background	Cytarabine	Small molecule	—	Intravenous
Background	Etoposide	Small molecule	—	Intravenous
Background	Melphalan	Small molecule	—	Intravenous
Background	Rituximab	Monoclonal antibody	—	Intravenous
Background	carmustine	Small molecule	—	Intravenous
Background	filgrastim	Protein / enzyme biologic	—	Subcutaneous