Clinical Trials Logo

Clinical Trial Summary

This is a Phase I/II, interventional, single-arm, open-label, treatment study designed to evaluate the safety and efficacy of Interleukin-7 and Interleukin-15 (IL-7/IL-15) manufactured chimeric antigen receptor (CAR)-20/19-T cells as well as the feasibility of a flexible manufacturing schema in adult patients with B cell malignancies that have failed prior therapies.


Clinical Trial Description

This is a Phase 1/Phase 2 study. The objectives are as follows: 1. Phase 1: Determine the safety of a fixed dose of 2.5x10^6 CAR-20/19-T cells/kg expanded with IL-7/IL-15 in relapsed refractory B-cell NHL with flexible 8/12-day manufacturing and a fixed 12-day manufacturing process along with an evaluation in chronic lymphocytic leukemia (CLL) and central nervous system (CNS) lymphoma. 2. Phase 1b: Four arms: Arm A: 8/12 flexible manufacturing arm. Determine safety, efficacy, and feasibility of flexible manufacturing. Arm B: Fixed 12-day manufacturing arm. Determine safety and efficacy of fixed CAR manufacturing. Arm C: 8/12 flexible manufacturing with mandated cryopreservation prior to infusion of LV20.19 CAR T-cells. Determine the impact of cryopreservation on safety or efficacy of LV20.19 CAR T-cells. Arm D: 8/12 flexible manufacturing expansion cohort in CLL. Determine safety and efficacy in CLL. Arm E: 8/12 flexible manufacturing cohort in central nervous system (CNS) lymphoma. 3. Phase 2 1. Determine the 3-month CR rate of CAR-20/19-T cells in MCL 2. Determine the feasibility of a flexible manufacturing process of CAR-20/19-T cells from patient apheresis products using the CliniMACS Prodigy Cell processing device ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04186520
Study type Interventional
Source Medical College of Wisconsin
Contact Medical College of Wisconsin Cancer Center Clinical Trials Offic
Phone 866-680-0505
Email cccto@mcw.edu
Status Recruiting
Phase Phase 1/Phase 2
Start date May 18, 2020
Completion date January 2025

See also
  Status Clinical Trial Phase
Enrolling by invitation NCT01804686 - A Long-term Extension Study of PCI-32765 (Ibrutinib) Phase 3
Completed NCT00001512 - Active Specific Immunotherapy for Follicular Lymphomas With Tumor-Derived Immunoglobulin Idiotype Antigen Vaccines Phase 1
Recruiting NCT03676504 - Treatment of Patients With Relapsed or Refractory CD19+ Lymphoid Disease With T Cells Expressing a Third-generation CAR Phase 1/Phase 2
Active, not recruiting NCT03245021 - Nivolumab Plus Rituximab in First-line Follicular Lymphoma gr 1-3A Phase 1
Active, not recruiting NCT03078855 - A Study to Evaluate the Effect of Vitamin D on PFS in Indolent Non-Hodgkin's Lymphoma Phase 3
Recruiting NCT05365659 - IKS03 in Patients With Advanced B Cell Non-Hodgkin Lymphomas Phase 1
Active, not recruiting NCT04082936 - A Study of Imvotamab Monotherapy and in Combination in Subjects With Relapsed/Refractory Non-Hodgkin Lymphoma Phase 1/Phase 2
Completed NCT02213263 - A Study Of PF-05280586 (Rituximab-Pfizer) Or MabThera® (Rituximab-EU) For The First-Line Treatment Of Patients With CD20-Positive, Low Tumor Burden, Follicular Lymphoma (REFLECTIONS B328-06) Phase 3
Completed NCT01691898 - A Study of Pinatuzumab Vedotin (DCDT2980S) Combined With Rituximab or Polatuzumab Vedotin (DCDS4501A) Combined With Rituximab or Obinutuzumab in Participants With Relapsed or Refractory B-Cell Non-Hodgkin's Lymphoma (NHL) Phase 1/Phase 2
Terminated NCT03585725 - A Pilot Investigator-Initiated Study of Ribavirin in Indolent Follicular Lymphoma and Mantle Cell Lymphoma Early Phase 1
Terminated NCT00772668 - Rituximab, Cyclophosphamide, Bortezomib, and Prednisone in Patients With Stage III/IV FL or MZL N/A
Recruiting NCT02892695 - PCAR-119 Bridge Immunotherapy Prior to Stem Cell Transplant in Treating Patients With CD19 Positive Leukemia and Lymphoma Phase 1/Phase 2
Terminated NCT02877082 - Tacrolimus, Bortezomib, & Thymoglobulin in Preventing Low Toxicity GVHD in Donor Blood Stem Cell Transplant Patients Phase 2
Terminated NCT02204982 - Study of Duvelisib in Combination With Rituximab vs Rituximab in Subjects With Previously Treated Follicular Lymphoma Phase 3
Terminated NCT00850499 - Phase 2 Study of VELCADE With Fludarabine in Comparison to Rituximab With Fludarabine in Follicular Lymphoma Patients Previously Treated With Rituximab Phase 2
Completed NCT02536664 - Non-Interventional Study to Examine Rituximab Treatment in Follicular Lymphoma Participants
Terminated NCT00475332 - Study to Treat Relapsed Follicular Non-Hodgkin's Lymphoma With Radiation and Bexxar Phase 2
Terminated NCT00136591 - A Phase 2 Study of Velcadeā„¢ in Subjects With Relapsed or Refractory Follicular B-Cell Lymphoma Phase 2
Not yet recruiting NCT06068881 - A Study to Assess Efficacy and Safety of Oral Tazemetostat in Adult Participants With Relapsed/Refractory Follicular Lymphoma That Does Not Have an "EZH2 Gain-of-function" Genetic Mutation Phase 2
Completed NCT04034056 - Untreated FolliculaR Lymphoma Treated With OBinituzumAb in a Non-interventional Study (URBAN)