A Study to Evaluate the Tolerability, Safety, and Efficacy of an Anti-CD19 CAR-T Product in Patie… (NCT06705530) | Clinical Trial Compass
CompletedPhase 1/2
A Study to Evaluate the Tolerability, Safety, and Efficacy of an Anti-CD19 CAR-T Product in Patients With B-cell Lymphoproliferative Disorders
Russia58 participantsStarted 2024-11-26
Plain-language summary
This study is testing a new type of treatment called anti-CD19 CAR-T cell therapy for adults with certain blood cancers that have returned or did not respond to previous treatments. CAR-T cells are a type of immune cell that is specially designed in a lab to target and destroy cancer cells with a marker called CD19. The main goals of this study are to find out if this treatment is safe, how well patients tolerate it, and how effective it is at controlling cancer.
The study will include 60 adults, ages 18-70, who meet specific criteria for participation. Patients will first receive a short course of chemotherapy to prepare their bodies for the CAR-T cells. The CAR-T cells will then be given in two doses through an IV. Patients will be monitored closely in the hospital for about a month to check for any side effects and see how their cancer responds. The researchers will also follow up with patients over time to learn more about how long the CAR-T cells stay active, how well they fight cancer, and the overall health of the patients after treatment.
Who can participate
Age range18 Years – 70 Years
SexALL
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Inclusion criteria
✓. b. In the case of Ph-positive ALL/LBL:
Exclusion criteria
✕. Tumor cell surface CD19 expression level \<20% for B-ALL by flow cytometry or no CD19 expression for lymphoma by immunohistochemical analysis.
✕. Acute/active hepatitis B, C, or acute HIV infection, COVID-19.
✕. Uncontrolled life-threatening infection (positive blood culture within 72 h prior to CAR-T product transfusion). Urinary tract infection is allowed. Patients receiving intravenous antibiotics prior to transfusion or in whom intravenous antibiotics have not been discontinued 7 days before inclusion in the study are not included. Prophylactic use of antibiotics, antiviral, and antifungal agents is allowed.
✕. CD3+ T-lymphocyte content in peripheral blood is less than 0.1\*10\^9 cells/L.
✕. Previous treatment with gene therapy products.
✕. Clinically significant CNS pathology (epilepsy, generalized convulsive disorder, paresis, aphasia, stroke, severe brain damage, dementia, Parkinson's disease, cerebellar disease, organic cerebral syndrome, psychosis) at present or in the anamnesis.
What they're measuring
1
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Timeframe: 28 days
2
Primary Efficacy Outcome: ORR
Timeframe: 28 days
Trial details
NCT IDNCT06705530
SponsorNational Research Center for Hematology, Russia
✕. NYHA class III or IV heart failure, coronary angioplasty or stenting, myocardial infarction, unstable angina, or any other significant cardiac pathology within the previous 6 months.
✕. Associated genetic syndromes (such as Nijmegen syndrome, Kostman syndrome, Schwachman syndrome, or any other known bone marrow failure syndrome).