NCT02153580

Cellular Immunotherapy Following Chemotherapy in Treating Patients With Recurrent Non-Hodgkin Lymphomas, Chronic Lymphocytic Leukemia, or B-Cell Prolymphocytic Leukemia

Active, enrolled Phase 1 Last updated 6 October 2025

What this trial tests

Phase 1 trial testing Autologous CD19CAR-CD28-CD3zeta-EGFRt-expressing Tn/mem-enriched T-lymphocytes in B-Cell Lymphoma, Unclassifiable, With Features Intermediate Between Diffuse Large B-Cell Lymphoma and Classic Hodgkin Lymphoma in 37 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

24 September 2014

Primary endpoint
2 September 2026

2 September 2026

Quick facts

Lead sponsor	City of Hope Medical Center
Phase	Phase 1
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	37
Start date	24 September 2014
Primary completion	2 September 2026
Estimated completion	2 September 2026
Sites	1 location across United States

Drugs / interventions tested

• Autologous CD19CAR-CD28-CD3zeta-EGFRt-expressing Tn/mem-enriched T-lymphocytes
• Bendamustine Hydrochloride — full drug profile →
• Cyclophosphamide (cyclophosphamide) — full drug profile →
• Etoposide (etoposide) — full drug profile →
• Fludarabine Phosphate (FLUDARABINE PHOSPHATE) — full drug profile →

Conditions studied

• B-Cell Lymphoma, Unclassifiable, With Features Intermediate Between Diffuse Large B-Cell Lymphoma and Classic Hodgkin Lymphoma — all drugs for B-Cell Lymphoma, Unclassifiable, With Features Intermediate Between Diffuse Large B-Cell Lymphoma and Classic Hodgkin Lymphoma →
• B-Cell Prolymphocytic Leukemia — all drugs for B-Cell Prolymphocytic Leukemia →
• High Grade B-Cell Lymphoma, Not Otherwise Specified — all drugs for High Grade B-Cell Lymphoma, Not Otherwise Specified →
• Post-Transplant Lymphoproliferative Disorder — all drugs for Post-Transplant Lymphoproliferative Disorder →

Sponsor

City of Hope Medical Center

Who can join

18 and older, any sex, with B-Cell Lymphoma, Unclassifiable, With Features Intermediate Between Diffuse Large B-Cell Lymphoma and Classic Hodgkin Lymphoma or B-Cell Prolymphocytic Leukemia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This phase I trial studies the side effects and best dose of cellular immunotherapy following chemotherapy in treating patients with non-Hodgkin lymphomas, chronic lymphocytic leukemia, or B-cell prolymphocytic leukemia that has come back. Placing a modified gene into white blood cells may help the body build an immune response to kill cancer cells.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Next generations of CAR-T cells - new therapeutic opportunities in hematology?
   Tomasik J, Jasiński M, Basak GW. · · 2022 · cited 98× · PMID 36389658 · DOI 10.3389/fimmu.2022.1034707
2. CD19-directed CAR T-cell therapy for treatment of primary CNS lymphoma.
   Siddiqi T, Wang X, Blanchard MS, Wagner JR, et al · · 2021 · cited 96× · PMID 34492703 · DOI 10.1182/bloodadvances.2020004106
3. The growing world of CAR T cell trials: a systematic review.
   Holzinger A, Barden M, Abken H. · · 2016 · cited 86× · PMID 27613725 · DOI 10.1007/s00262-016-1895-5
4. Absence of Replication-Competent Lentivirus in the Clinic: Analysis of Infused T Cell Products.
   Cornetta K, Duffy L, Turtle CJ, Jensen M, et al · · 2018 · cited 73× · PMID 28970045 · DOI 10.1016/j.ymthe.2017.09.008
5. Trial Watch: Adoptively transferred cells for anticancer immunotherapy.
   Fournier C, Martin F, Zitvogel L, Kroemer G, et al · · 2017 · cited 55× · PMID 29147628 · DOI 10.1080/2162402x.2017.1363139
6. Immune Dysfunctions and Immune-Based Therapeutic Interventions in Chronic Lymphocytic Leukemia.
   Griggio V, Perutelli F, Salvetti C, Boccellato E, et al · · 2020 · cited 54× · PMID 33312177 · DOI 10.3389/fimmu.2020.594556
7. CAR T-cell-associated neurotoxicity in central nervous system hematologic disease: Is it still a concern?
   Velasco R, Mussetti A, Villagrán-García M, Sureda A. · · 2023 · cited 39× · PMID 37090983 · DOI 10.3389/fneur.2023.1144414
8. A Deep Insight Into CAR-T Cell Therapy in Non-Hodgkin Lymphoma: Application, Opportunities, and Future Directions.
   Marofi F, Rahman HS, Achmad MH, Sergeevna KN, et al · · 2021 · cited 37× · PMID 34248965 · DOI 10.3389/fimmu.2021.681984