Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCSD
Dates
study started
estimated completion
Principal Investigator
by Carolyn Mulroney, MD (ucsd)
Photo of Carolyn Mulroney
Carolyn Mulroney

Description

Summary

CLBR001 + SWI019 is an combination investigational immunotherapy being evaluated as a potential treatment for patients diagnosed with B cell malignancies who are refractory or unresponsive to salvage therapy or who cannot be considered for or have progressed after autologous hematopoietic cell transplantation. This first-in-human study will assess the safety and tolerability of CLBR001 + SWI019 and is designed to determine the maximum tolerated dose (MTD) or optimal SWI019 dose (OSD). Patients will be administered a single infusion of CLBR001 cells followed by cycles of SWI019. The study will also assess the pharmacokinetics and pharmacodynamics of CLBR001 + SWI019.

Official Title

A Phase 1, Open-label, Dose Escalating Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Clinical Activity of the Combination of CLBR001 and SWI019 in Patients With Relapsed/Refractory B-cell Malignancies

Details

CLBR001 + SWI019 is a two-component therapy comprising an autologous chimeric antigen receptor T (CAR-T) cell product (CLBR001, the switchable CAR-T cell (sCAR-T)) and an anti-CD19 (cluster of differentiation antigen 19) antibody (SWI019, the switch, a biologic). In combination, SWI019 acts as an adapter molecule that controls the activity of the CLBR001 CAR-T cell product.

Keywords

Relapsed/Refractory B-cell Lymphomas Diffuse Large B Cell Lymphoma (DLBCL) Follicular Lymphoma (FL) Chronic Lymphocytic Leukemia (CLL) Marginal Zone Lymphoma (MZL) Mantle Cell Lymphoma Small Lymphocytic Lymphoma (SLL) Primary Mediastinal Large B Cell Lymphoma Transformed Follicular Lymphoma CAR-T Cell Therapy Switchable CAR-T Cell Autologous Cell Therapy CD19 Positive Disease CD19 CAR-T Cell Blood Cancer Hematological malignancy Neoplasms Lymphoma Lymphoma, Follicular Leukemia, Lymphocytic, Chronic, B-Cell Lymphoma, B-Cell Lymphoma, Mantle-Cell Lymphoma, Large B-Cell, Diffuse CLBR001 and SWI019 Dose Escalation

Eligibility

You can join if…

Open to people ages 18 years and up

  • Patients with relapsed / refractory previously treated B cell malignancies (according to the World Health Organization classification; 2017)
  • Chemotherapy-refractory disease
  • Patients must have received adequate prior therapy including at least two lines of prior therapies including anthracycline-containing chemotherapy, anti-CD20 (cluster of differentiation antigen 20) therapies and/or Brutton's tyrosine kinase (BTK) inhibitors
  • Patients treated with prior CD19 targeted molecules (e.g., Blincyto) must have confirmed CD19+ disease
  • Patients must be ineligible for allogeneic stem cell transplant (SCT)
  • Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 or 1
  • Estimated life expectancy of ≥ 12 weeks from the first day of SWI019 dose administered
  • Willing to undergo pre- and post-treatment core needle biopsy
  • Adequate hematological, renal, pulmonary, cardiac, and liver function
  • Resolved adverse events of any prior therapy to either baseline or CTCAE Grade ≤1
  • Women of childbearing potential, a negative pregnancy test and must agree to practice effective birth control
  • Men sexually active with female partners of child bearing potential must agree to practice effective contraception
  • Willing and able to comply with scheduled visits, treatment plan, laboratory tests and other procedures

You CAN'T join if...

  • Patients diagnosed with disease histologies including pediatric lymphomas/leukemias, Burkitt lymphoma, lymphoplasmacytic lymphomas, monoclonal gammopathy of undetermined significance (MGUS), T-cell histiocyte large B cell lymphoma
  • Pregnant or lactating women
  • Active bacterial, viral, and fungal infections
  • History of allogeneic stem cell transplantation
  • Treatment with any prior CD19 or CD20 CAR-T
  • Patients receiving live (attenuated) vaccines within 4 weeks of screening visit or need for live vaccine on study
  • Patients with known active central nervous system (CNS) disease. Patients with prior CNS disease that has been effectively treated may be eligible
  • History of Class III or IV New York Heart Association (NYHA) heart failure, myocardial infarction, unstable angina or other significant cardiac disease within 6 months of screening
  • Involvement of cardiac tissue by lymphoma
  • Uncontrolled autoimmune hemolytic anemia or idiopathic thrombocytopenic purpura (ITP)
  • HIV-1 and HIV-2 antibody positive patients

Locations

  • University of California at San Diego accepting new patients
    San Diego California 92093 United States
  • City of Hope National Medical Center accepting new patients
    Duarte California 91010 United States

Lead Scientist at UC Cancer

  • Carolyn Mulroney, MD (ucsd)
    Co-Investigator on several clinical trials in the Blood and Marrow Transplantation Division: BMTCTN 0402, IRB # 101006, A Phase III Randomized, Multicenter Trial comparing Sirolimus/Tacrolimus with Tacrolimus/Methotrexate as a Graft-Versus-Host Disease (GVHD) Prophylaxis After HLA- Matched, Related Peripheral Blood Stem Cell transplantation. B.A.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Calibr, a division of Scripps Research
ID
NCT04450069
Phase
Phase 1
Study Type
Interventional
Last Updated