Supercharged immune cells take on tough lymphoma after transplant
NCT ID NCT02051257
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-phase trial tests a new approach for patients with aggressive B-cell lymphoma that has come back after treatment. Researchers take a patient's own immune cells (T cells), modify them in the lab to better recognize and kill lymphoma cells, and give them back after a standard stem cell transplant. The goal is to find the highest safe dose and see if these enhanced cells can lower the chance of the cancer returning. About 51 people with high-risk lymphoma are participating.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
About 51 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Jun 2014
- Expected to finish
-
Mar 2027
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Research participants enrolled are patients with an indication to be considered for HSCT, who are diagnosed with intermediate or high grade B-cell non-Hodgkin lymphoma (NHL) (e.g. diffuse large B-cell lymphoma \[DLBCL\], mantle cell lymphoma \[MCL\], or transformed NHL), and that have either (1) recurrence/progression following prior therapy, or (2) verification of high-risk disease in first or subsequent remission * Karnofsky performance status (KPS) of \>= 70% at time of enrollment * 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 history of intermediate or high grade B-cell NHL (e.g., DLBCL, MCL, or transformed NHL) * Negative serum pregnancy test for women of child-bearing potential * Research participant has an indication to be considered for autologous stem cell transplantation * All subjects must have the ability to understand and the willingness to sign a written informed consent ELIGIBILITY CRITERIA AT TIME OF INFUSION OF GENETICALLY MODIFIED AUTOLOGOUS T CELLS: * Research participant has a released cryopreserved T cell product * Research participant did not have evidence of disease progression after salvage therapy and therefore underwent an autologous myeloablative transplantation with hematopoietic progenitor cell autologous (HPC\[A\]) rescue procedure * Not requiring supplemental oxygen or mechanical ventilation, oxygen saturation 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 mg/dL * Total bilirubin =\< 5.0 mg/dL * Research participant without clinically significant encephalopathy/new focal deficits * No clinical evidence of uncontrolled active infectious process Exclusion Criteria: * Research participants with any uncontrolled illness including ongoing or active infections; research participants with known active hepatitis B or C infection; research participants who are human immunodeficiency virus (HIV) positive based on testing performed within 4 weeks of enrollment; research participants with any signs or symptoms of active infection, positive blood cultures or radiological evidence of infections * Research participants receiving any other investigational agents, or concurrent biological, chemotherapy, or radiation therapy * Research participants with a history of allergic reactions attributed to compounds of similar chemical or biological composition to cetuximab * Research participants with known brain metastases (central nervous system \[CNS\] involvement either parenchymal or leptomeningeal involvement) * Research participants with presence of other active malignancy; however, research participants with history of prior malignancy treated with curative intent and in complete remission are eligible * Failure of research participant to understand the basic elements of the protocol and/or the risks/benefits of participating in this phase I study; a legal guardian may substitute for the research participant * History of allogeneic HSCT or prior autologous HSCT * Any standard contraindications to myeloablative HSCT per standard of care practices at COH * Dependence on corticosteroids * Defined as doses of corticosteroids of greater than or equal to 5 mg/day of prednisone or equivalent doses of other corticosteroids * Note: topical and inhaled corticosteroids in standard doses and physiologic replacement for subjects with adrenal insufficiency are allowed * Currently receiving another investigational agent * Active autoimmune disease requiring systemic immunosuppressive therapy * 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
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Recurrent diffuse large B-cell lymphoma are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
City of Hope Medical Center
Duarte, California, 91010, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a Multi-Drug combo outsmart resistant lymphoma?
- Could adjusting chemo doses boost CAR T-Cell success against tough lymphoma?
- Radiation boost may supercharge CAR T-Cell therapy against tough lymphoma
- Combination therapy aims to outsmart tough lymphoma
- New combo approach aims to boost CAR-T success in tough lymphoma
- New drug duo takes on tough lymphoma