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NCT01815749Active, not recruitingPhase 1

Genetically Modified T-cell Infusion Following Peripheral Blood Stem Cell Transplant in Treating Patients With Recurrent or High-Risk Non-Hodgkin Lymphoma

Phase I Study of Cellular Immunotherapy Using Central Memory-Enriched T Cells Lentivirally Transduced to Express a CD19-Specific, CD28-Costimulatory Chimeric Receptor and a Truncated EGFR Following Peripheral Blood Stem Cell Transplantation for Patients With High-Risk Intermediate Grade B-Lineage Non-Hodgkin Lymphoma

Source: ClinicalTrials.gov · Last updated 25 Jun 2026

Brief summary (registry, in English)

This phase I trial studies the side effects and best dose of genetically modified T-cells following peripheral blood stem cell transplant in treating patients with recurrent or high-risk non-Hodgkin lymphoma. Giving chemotherapy before a stem cell transplant helps stop the growth of cancer cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Removing the T cells from the donor cells before transplant may stop this from happening. Giving an infusion of the donor's T cells (donor lymphocyte infusion) later may help the patient's immune system see any remaining cancer cells as not belonging in the patient's body and destroy them (called graft-versus-tumor effect)

Status (registry)
Active, not recruiting
Phase (registry)
Phase 1
Study type
Interventional
Enrollment
30 (estimated)
First submitted
19 Mar 2013
Start date
8 Oct 2013
Primary completion date
9 Jan 2018
Lead sponsor
City of Hope Medical Center
NCT number
NCT01815749

What you commit to

  • Study type: Interventional · Phase 1
  • Planned participants: 30
  • From 8 Oct 2013 to the primary completion date, 9 Jan 2018
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Research participants receiving any other investigational agents, or concurrent biological, chemotherapy or radiation therapy
  • History of allogeneic HSCT or prior autologous HSCT
  • Dependence on corticosteroids

Other illness

  • Research participants with any uncontrolled illness including ongoing or active infection; research participants with known active hepatitis B or C infection; research participants who are human immunodeficiency virus (HIV) seropositive based on testing performed within 4 weeks of enrollment; research participants with any signs of symptoms of active infection, positive blood cultures or radiological evidence of infections
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to cetuximab
  • Research participants with presence of other malignancy or history of prior malignancy within 5 years of study entry; although patients treated with curative intent within 5 year are eligible; this exclusion rule does not apply to non-melanoma skin tumors and in-situ cervical cancer
  • Failure of research participant to understand the basic elements of the protocol and/or the risks/benefits of participating in this phase I/II study; a legal guardian may substitute for the research participant
  • Active autoimmune disease requiring systemic immunosuppressive therapy

Other

  • Research participants with known brain metastases (central nervous system \[CNS\] involvement or parenchymal or leptomeningeal involvement)
  • Any standard contraindications to myeloablative HSCT per standard of care practices at COH
  • Research participants will be excluded, who in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study

Who the study is looking for

  • Research participants enrolled are patients with an indication to be considered for HSCT, who are diagnosed with intermediate grade B-cell NHL (e.g., DLBCL, MCL or transformed NHL), and that have either recurrence/progression following prior therapy, or verification of high-risk disease in first remission
  • Karnofsky performance status of \>= 70% and a life expectancy \>= 16 weeks at time of enrollment
  • Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control or abstinence) prior to study entry and for six months following duration of study participation; should a woman become pregnant or suspect that she is pregnant while participating on the trial, she should inform her treating physician immediately
  • City of Hope (COH) pathology review confirms that research participant's diagnostic material is consistent with the history of intermediate grade B-cell NHL (e.g., DLBCL, MCL or transformed NHL)
  • Negative serum pregnancy test for women of childbearing potential
  • Research participant has an indication to be considered for autologous stem cell transplantation
  • All patients must have the ability to understand and the willingness to sign a written informed consent
    • ELIGIBILITY TO UNDERGO AUTOLOGOUS MYELOABLATIVE TRANSPLANTATION WITH HEMATOPOETIC PROGENITOR CELL (HPC)A RESCUE
  • Research participant meets all standard clinical parameters for candidates of autologous transplant as described in the current COH Hematopoietic Cell Transplant Standard Operating Policies, Procedures and Protocols
  • Patient Evaluation \& Selection or Deferral for hematopoietic cell transplantation (HCT)
  • Research participant is scheduled to receive a standard chemotherapy-based conditioning regimen, such as cyclophosphamide, carmustine, etoposide (CBV) or carmustine, etoposide, cytarabine, melphalan (BEAM)
  • Research participant has a cryopreserved unselected HPCA product of at least 3 x 10\^6/kg CD34+ cells
  • Research participant does not have evidence of disease progression after salvage therapy
    • ELIGIBILITY CRITERIA AT TIME OF INFUSION OF GENETICALLY MODIFIED AUTOLOGOUS T CELLS
  • Research participant has a released cryopreserved T cell product
  • Research participant has undergone an autologous HPC(A) procedure
  • Not requiring supplemental oxygen or mechanical ventilation, oxygen saturation of 90% or higher on room air
  • Not requiring pressor support, not having symptomatic cardiac arrhythmias
  • Lack of acute renal failure/requirement for dialysis, as evidenced by creatinine \< 1.6 - Total bilirubin =\< 5.0
  • Research participant without clinically significant encephalopathy/new focal deficits
  • No clinical evidence of uncontrolled active infections process

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
City of Hope Medical Center
Coordinator of this site? Confirm its status
DuarteUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.