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New treatment option for Recurrent B-Cell Non-Hodgkin Lymphoma
Official title CD19-Directed CAR-T Cell Therapy for the Treatment of Relapsed/Refractory B Cell Malignancies
ClinicalTrials.gov ID: NCT04892277
What this study is testing
What is Autologous Anti-CD19 CAR-expressing T-lymphocytes IC19/1563?
Autologous Anti-CD19 CAR-expressing T-lymphocytes IC19/1563 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for recurrent b-cell non-hodgkin lymphoma.
Also referred to as Autologous CAR-T Cells IC19/1563, CD19-directed CAR-T Cells IC19/1563.
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 studies the effects of CD-19 directed chimeric antigen receptor (CAR)-T cell therapy for the treatment of patients with B cell malignancies that have come back (recurrent) or have not responded to treatment (refractory). CD-19 CAR-T cells use some of a patient's own immune cells, called T cells, to kill cancer.
- 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
- Age \>= 18 years
- Relapsed or refractory CD19+ B cell malignancies of the one of the following histopathology:
- Biopsy proven B-cell non-Hodgkin lymphoma (NHL) of any histopathology (including Richter Transformation of CLL); relapsed or refractory disease...
- Two or more prior lines of therapy, at least one anthracycline containing regimen, unless intolerable. Exception: Patients with Richter...
- Demonstration of progressive or stable disease by positron emission tomography/computed tomography (PET/CT) or CT criteria as the best response to...
You likely can't join if
- Any of the following because this study involves an investigational agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus...
- Pregnant persons
- Nursing persons
- Women of childbearing potential who are unwilling to employ highly effective contraception
- Sexually active males who are not willing to use contraception during the study and for \>= 12 months after IC19/1563 therapy
- Patients who are able to obtain market approved CD19 CAR T-cell therapies
See the full eligibility criteria
Who can join
- Age \>= 18 years
- Relapsed or refractory CD19+ B cell malignancies of the one of the following histopathology:
- Biopsy proven B-cell non-Hodgkin lymphoma (NHL) of any histopathology (including Richter Transformation of CLL); relapsed or refractory disease defined as:
- Two or more prior lines of therapy, at least one anthracycline containing regimen, unless intolerable. Exception: Patients with Richter transformation of CLL are eligible if they had \>= one prior treatment, including...
- Demonstration of progressive or stable disease by positron emission tomography/computed tomography (PET/CT) or CT criteria as the best response to the most recent chemotherapy regimen according to the revised Lugano...
- Measurable disease defined as measurable by CT portion of a PET/CT: To be considered measurable, the must be at least one lesion that has a single diameter of (\>1.5 cm Note: Lesions that have been previously irradiated...
- Biopsy proven SLL or flow cytometry proven CLL; relapsed disease defined as:
- \>= two prior lines of therapy, and/or \>= 6 months of second line prior BTK inhibition (e.g. venetoclax and ibrutinib). Exception: Patients in stable disease (SD) or partial response (PR) with a known ibrutinib...
- Demonstration of progressive or stable disease by PET/CT or CT criteria according to the International Workshop on Chronic Lymphocytic Leukemia (iwCLL2018) criteria
- Measurable disease by CT portion of a PET/CT where at least one lesion has a single diameter of \>1.5 cm or peripheral blood absolute blood lymphocyte count (ALC) of \> 5000. Note: Lesions that have been previously...
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1
- Hemoglobin \>= 8.0 g/dL (=\< 14 days prior to registration)
- Absolute neutrophil count (ANC) \>= 500/mm\^3 (=\< 14 days prior to registration)
- Platelet count \>= 30,000/mm\^3 (=\< 14 days prior to registration)
- Total bilirubin =\< 2.0 mg/dL (with the exception of people with Gilbert's syndrome. people with Gilbert's syndrome may be included if their total bilirubin is =\< 3.0 x upper limit of normal (ULN) and direct bilirubin...
- Alanine aminotransferase (ALT) and aspartate transaminase (AST) =\< 3 x ULN (=\< 14 days prior to registration)
- Prothrombin time (PT) / international normalized ratio (INR) and/or activated partial thromboplastin time (aPTT) =\< 1.5 x ULN OR if patient is receiving anticoagulant therapy and INR or aPTT is within target range of...
- Calculated creatinine clearance \>= 45 ml/min using the Cockcroft-Gault formula (=\< 14 days prior to registration)
- Cardiac ejection fraction \>= 50% and no evidence of clinically significant pericardial effusion as determined by an echocardiogram (ECHO) or multigated acquisition scan (MUGA) scan
- Baseline oxygen saturation \>= 92% on room air
- Negative serum pregnancy test done =\< 7 days prior to registration, for persons of childbearing potential only
- Women patients of child bearing potential, including women with tubal ligations, must commit to using use 2 highly effective forms of birth control (defined as the use of an intrauterine device, a barrier method with...
- Provide written informed consent
- Willingness to provide mandatory blood specimens for correlative research
- Willing to return to enrolling institution for follow-up (during the Active Monitoring Phase of the study)
What rules you out
- Any of the following because this study involves an investigational agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown:
- Pregnant persons
- Nursing persons
- Women of childbearing potential who are unwilling to employ highly effective contraception
- Sexually active males who are not willing to use contraception during the study and for \>= 12 months after IC19/1563 therapy
- Patients who are able to obtain market approved CD19 CAR T-cell therapies
- Live vaccine =\< 6 weeks prior to start of registration
- Autologous stem cell transplant =\< 6 weeks of registration
- History of allogenic stem cell transplant if was performed less than 100 days prior to registration, if patients have active graft-versus host disease (GVHD) or are if patients are on chronic immunosuppression. Patients...
- History of a seizure disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease with central nervous system (CNS) involvement
- Any form of primary immunodeficiency such as severe combined immunodeficiency disease
- Current need of systemic corticosteroid therapy, in doses over 20 mg /day of prednisone or equivalent forms of steroids
- History of severe immediate hypersensitivity reaction to CART19, stem cell infusion dimethyl sulfoxide (DMSO) or any of the CAR-T cryopreservation ingredients
- History of malignancy other than non-melanoma skin cancer, carcinoma in situ (e.g. cervix, bladder, breast) or early stage cancers (Stage I or II), unless disease free for \>= 2 years
- Clinically significant active infection (e.g. simple urinary tract infection [UTI], bacterial pharyngitis allowed) or currently receiving IV antibiotics or have received IV antibiotics =\< 7 days prior to registration...
- Known history of human immunodeficiency virus (HIV) infection or acute or chronic hepatitis B or hepatitis C infection. people with a history of hepatitis infection must have cleared their infection as determined by...
- History of any of the following cardiovascular conditions =\< 6 months:
- Class III or IV heart failure as defined by the New York Heart Association (NYHA)
- Cardiac angioplasty or stenting
- Myocardial infarction
- Unstable angina
- Or other clinically significant cardiac disease
- Any other acute or chronic medical or psychiatric condition that may increase the risk associated with study participation or investigational product administration or that, in the judgment of the investigator, would...
- Concurrent cancer therapy. The following are exceptions:
- Treatment with therapies may continue at time of registration; however, the washout period must be met prior to leukapheresis
- Treatment with any other investigational agent may continue at time of registration provided last date of treatment is =\< 14 days prior to leukapheresis.
The study team makes the final eligibility decision.
Where it's taking place
- Rochester, Minnesota, 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 Rochester, Minnesota, United States. 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.