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New treatment option for AIDS-Related Diffuse Large B-cell Lymphoma
Official title Immune Cell Therapy (CAR-T) for the Treatment of Patients With HIV and B-Cell Non-Hodgkin Lymphoma
ClinicalTrials.gov ID: NCT05077527
What this study is testing
What is Axicabtagene Ciloleucel?
Axicabtagene Ciloleucel is an investigational medicine, given as an once-weekly infusion into a vein, being studied as a potential treatment for aids-related diffuse large b-cell lymphoma.
Also referred to as KTE C19, KTE-C19.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This phase I trial evaluates the side effects and usefulness of axicabtagene clioleucel (a CAR-T therapy) and find out what effect, if any, it has on treating patients with HIV-associated aggressive B-cell non-Hodgkin lymphoma that has come back (relapsed) or not responded to treatment (refractory). T cells are infection fighting blood cells that can kill tumor cells.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Participant with age \>= 18 years at the time of consent. Because no dosing or adverse event data are currently available on the use of axicabtagene...
- Participant is able to understand and willing to sign a written informed consent document before any study procedures
- Participant must have R/R aggressive B-cell NHL of the following histologies:
- Diffuse large B-cell lymphoma (DLBCL, including transformed from indolent histology)
- High-grade B-cell lymphoma
You likely can't join if
- Participants felt to have a high prospect of clinically benefiting from autologous transplantation
- Participants with central nervous system (CNS)-only involvement by malignancy (note: participants with secondary CNS involvement are allowed on study
- Participants with a second prior or concurrent malignancy that, in the opinion of the investigator, has a natural history or treatment course that...
- Treatment with alemtuzumab within 6 months before anticipated leukapheresis, or treatment with fludarabine or cladribine within 3 months before...
- Participants with uncontrolled systemic fungal, bacterial, viral, or other infection despite appropriate antibiotics or other treatment at the time...
- Presence of acute or chronic graft-versus-host disease
See the full eligibility criteria
Who can join
- Participant with age \>= 18 years at the time of consent. Because no dosing or adverse event data are currently available on the use of axicabtagene ciloleucel in participants \< 18 years of age, children are excluded...
- Participant is able to understand and willing to sign a written informed consent document before any study procedures
- Participant must have R/R aggressive B-cell NHL of the following histologies:
- Diffuse large B-cell lymphoma (DLBCL, including transformed from indolent histology)
- High-grade B-cell lymphoma
- Primary mediastinal B-cell lymphoma
- Follicular lymphoma, grade 3B
- Participant must have been treated with an anthracycline and rituximab (or other CD20-targeted agent) and have R/R disease after at least 2 lines of therapy
- At least 2 weeks or 5 half-lives, whichever is shorter, must have elapsed since any prior systemic cancer therapy at the time the subject provides consent
- Evaluable disease as either:
- Positron emission tomography (PET)-positive disease according to the "Recommendations for Initial Evaluation, Staging, and Response Assessment of Hodgkin and Non-Hodgkin Lymphoma: The Lugano Classification", or
- Bone marrow involvement assessed by bone marrow biopsy
- Eastern Cooperative Oncology Group ECOG performance status =\ = 60%)
- Serum creatinine =\ 30 mL/min/1.73 m\^2 (within 4 weeks before enrollment)
- Alanine aminotransferase (ALT) =\< 5 x ULN and total bilirubin \< 2.0 mg/dL (or \< 3.0 mg/dL for people with Gilbert's syndrome or lymphomatous infiltration of the liver or if taking atazanavir or indinavir (within 4...
- Adequate pulmonary function, defined as =\ = 92% on room air (within 4 weeks before enrollment)
- Adequate cardiac function, defined as left ventricular ejection fraction (LVEF) \>= 40% as assessed by echocardiogram or multiple uptake gated acquisition (MUGA) scan performed within 1 month of determination of...
- Absolute neutrophil count: \>= 1,000/mm\^3 (within 4 weeks before enrollment)
- Platelets: \>= 75,000/mm\^3 (within 4 weeks before enrollment)
- Total bilirubin: =\< 1.5 x institutional upper limit of normal (ULN) (3.0 x ULN for patients with Gilbert syndrome) If, however, the elevated bilirubin is felt to be secondary to antiretroviral therapy, the total...
- Adequate vascular access for leukapheresis procedure and for administration of the cellular product (either peripheral line or leukapheresis catheter)
- Participants who have received previous CD19-targeted therapy must have CD19-positive lymphoma confirmed on a biopsy since completing the prior CD19-targeted therapy
- The effects of axicabtagene ciloleucel on the developing human fetus are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth...
- Men who have partners of childbearing potential must agree to use an effective barrier contraceptive method before study entry, for the duration of study participation, and for 1 year after the last dose of axicabtagene...
- Documentation of HIV-1 infection by means of any one of the following:
- Documentation of HIV diagnosis in the medical record by a licensed health care investigator;
- Documentation of receipt of antiretroviral therapy (ART) (at least two different medications that do not constitute a prescription for pre-exposure prophylaxis [PrEP]) by a licensed health care investigator...
- HIV-1 ribonucleic acid (RNA) detection by a licensed HIV-1 RNA assay demonstrating \>1000 RNA copies/mL;
- Any federally approved, licensed HIV screening antibody and/or HIV antibody/antigen combination assay confirmed by a second licensed HIV assay such as a HIV-1 Western blot confirmation or HIV rapid multispot antibody...
- HIV viral load below 50 copies/mL by FDA-approved assays within 4 weeks prior to registration
- A CD4 cell count must be obtained within 4 weeks before enrollment at any U.S. laboratory that has a clinical laboratory improvement amendments (CLIA) certification or its equivalent. Twenty participants will be studied...
- Participants who have hepatitis C (reactive anti-HCV antibody) and hepatitis B (HBsAg positive and/or anti-HBc-Total positive), may be enrolled, provided total bilirubin is =\< 1.5 x institutional upper limit of normal...
- Participants with hepatitis B core antibody positive must be on an antiviral agent to suppress hepatitis B throughout the study and be willing to continue therapy for at least one year after axicabtagene infusion
- Participants who are willing to continue ART during leukapheresis, manufacturing and infusion and post infusion of axicabtagene ciloleucel
What rules you out
- Participants felt to have a high prospect of clinically benefiting from autologous transplantation
- Participants with central nervous system (CNS)-only involvement by malignancy (note: participants with secondary CNS involvement are allowed on study
- Participants with a second prior or concurrent malignancy that, in the opinion of the investigator, has a natural history or treatment course that has the potential to interfere with the safety or how well it works...
- Treatment with alemtuzumab within 6 months before anticipated leukapheresis, or treatment with fludarabine or cladribine within 3 months before anticipated leukapheresis
- Participants with uncontrolled systemic fungal, bacterial, viral, or other infection despite appropriate antibiotics or other treatment at the time of enrollment
- Presence of acute or chronic graft-versus-host disease
- History of any one of the following cardiovascular conditions within the past 6 months: class III or IV heart failure as defined by the New York Heart Association, cardiac angioplasty or stenting, myocardial infarction...
- History or presence of clinically relevant CNS pathology such as epilepsy, seizure, paresis, aphasia, stroke, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, or psychosis
- Pregnant or nursing women. NOTE: Women of reproductive potential must have a negative serum pregnancy test performed within 48 hours before starting conditioning chemotherapy. Pregnant women are excluded from this study...
- Use of the following:
- Therapeutic doses of corticosteroids (defined as \> 20 mg/day prednisone or equivalent) within 7 days before leukapheresis or 72 hours before axicabtagene ciloleucel administration. Physiologic replacement, topical, and...
- Chemotherapy given after leukapheresis to maintain disease control must be stopped \>= 7 days before conditioning chemotherapy
- Cytotoxic chemotherapeutic agents that are not considered lymphotoxic (see below) within 1 week before leukapheresis. Oral chemotherapeutic agents, including lenalidomide and ibrutinib, are allowed if at least 3...
- Lymphotoxic chemotherapeutic agents (e.g., cyclophosphamide, ifosfamide, bendamustine) within 2 weeks before leukapheresis
- Experimental agents received within 4 weeks before leukapheresis unless no response or disease progression is documented while on the experimental therapy and at least 3 half-lives have elapsed before leukapheresis
- Immunosuppressive therapies within 4 weeks before leukapheresis and axicabtagene ciloleucel administration (e.g., calcineurin inhibitors, methotrexate, or other chemotherapeutics, mycophenolate, rapamycin, thalidomide...
- Donor lymphocyte infusions (DLI) within 6 weeks before axicabtagene ciloleucel administration
- Radiation within 1 week before leukapheresis. people must have progressive disease in irradiated lesions or have additional non-irradiated, PET-positive lesions to be eligible. However, palliative radiation to a single...
- Prior receipt of CAR T-cell therapy
- Participants with signs or symptoms indicative of active CNS involvement are excluded from the protocol, with the following exceptions: The following patients are included in the protocol:
- Participants with previously treated CNS involvement by lymphoma or leukemia, who and have no neurologic symptoms and no evidence of active lymphoma or leukemia in the CNS by total spine and brain gadolinium enhanced...
- Participants with active CNS involvement and stable neurologic symptoms for at least 3 weeks before leukapheresis and without neurologic progression prior to axi-cel infusion. These patients should have assessment by a...
- Inhaled or topical steroids and adrenal replacement doses =\ = 10 mg/day prednisone equivalents. A brief course of corticosteroids for prophylaxis (e.g., contrast dye allergy) or for treatment of non-autoimmune...
- The participant has not recovered to baseline or CTCAE =\< grade 1 from toxicity due to all prior therapies except =\< grade 2 alopecia, neuropathy, and other non-clinically significant adverse events (AEs), provided...
- Opportunistic infection within the last 3 months, with the exception of oropharyngeal candidiasis
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to axicabtagene ciloleucel or other agents used in study
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, or psychiatric illness with potential to limit compliance with study requirements
The study team makes the final eligibility decision.
Where it's taking place
- Duarte, California, United States
- Chicago, Illinois, United States
- New York, New York, United States
- The Bronx, New York, United States
- Columbus, Ohio, United States
- Philadelphia, Pennsylvania, United States
- Salt Lake City, Utah, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Duarte, California, United States; Chicago, Illinois, United States; New York, New York, United States; The Bronx, New York, United States; Columbus, Ohio, United States; Philadelphia, Pennsylvania, United States and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.