Tisagenlecleucel

Tisagenlecleucel Uses, Dosage, Side Effects, Food Interaction and all others data.

Tisagenlecleucel is a CD19-directed genetically modified autologous T cell immunotherapy, or a CAR-T cell therapy for B-cell acute lymphoblastic leukemia. It was granted approval by FDA in August 2017 under the market name Kymriah. Tisagenlecleucel is an immunocellular therapy that involves autologous T cells that are collected from each individual patient and genetically engineered to express a specific protein called a chimeric antigen receptor (CAR) that specifically target CD19 antigens. Modified T cells are infused back into the patient's body. These CD19-directed chimeric antigen receptors (CD19 CAR-T cells) direct the T cells to targt and kill leukiemia cells that express a specific antigen (CD19) on the cell surface.

In a multicenter clinical trial involving pediatric and young adult patients with relapsed or refractory B-cell precursor ALL, the overall remission rate within three months of treatment was 83 percent .

Tisagenlecleucel demonstrates efficacy in re-inducing remission in patients with refractory B-cell precursor acute lymphoblastic leukemia. The sole purpose of the therapy is to eliminateCD19-expressing malignant and normal cells with specificity and increased chance of remission.

Tisagenlecleucel
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Uses during Pregnancy
Uses during Breastfeeding
Accute Overdose
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Trade Name	Tisagenlecleucel
Availability	Prescription only
Generic	Tisagenlecleucel
Tisagenlecleucel Other Names	Adoptive immunotherapy agent CTL019, CAR.CD19-Redirected T cells, Tisagenlecleucel, Tisagenlecleucel-T
Related Drugs	prednisone, methotrexate, rituximab, Rituxan, doxorubicin, cyclophosphamide, Revlimid, imatinib, Gleevec, vincristine
Weight	+,
Type	Intravenous Suspension, Intravenous
Groups	Approved, Investigational
Therapeutic Class
Manufacturer
Available Country	United States
Last Updated:	September 19, 2023 at 7:00 am

Uses

Tisagenlecleucel is a CAR T cell therapy for relapsed or refractory large B-cell lymphoma and diffuse large B-cell lymphoma.

Indicated for the treatment of patients up to 25 years of age with B-cell precursor acute lymphoblastic leukemia (ALL) that is refractory or in second or later relapse.

Tisagenlecleucel is also used to associated treatment for these conditions: Refractory B-cell precursor acute lymphoblastic leukemia, Second or later relapsed B-cell precursor acute lymphoblastic leukemia

How Tisagenlecleucel works

Tisagenlecleucel is a CD19-directed genetically modified autologous T cell immunotherapy that involves genetically modified autologous T cells isolated from each individual patient. The reprogramming of the patient's T cells uses a lentiviral vector to encode an anti-CD19 chimeric antigen receptor (CAR). The CAR is comprised of a murine single-chain antibody fragment (scFv) specific for CD19, followed by a CD8 hinge and transmembrane region that is fused to the intracellular signaling domains from 4-1BB (CD137) and CD3 zeta . These intracellular costimulatory signaling domains increase the expansion, longer-term persistence and potency of CAR T cells : the CD3 zeta component is critical for initiating T-cell activation and antitumor activity, while 4-1BB enhances the expansion and persistence of tisagenlecleucel {FDA Label, A20379]. Upon binding to CD19-expressing cells, the CAR transmits a signal to promote T-cell expansion, activation, target cell elimination, and persistence of the tisagenlecleucel cells .

Toxicity

Genotoxicity assay, carcinogenicitiy assay, and studies assesssing the effect of drug on fertility have not been conducted for tisagenlecleucel. According to in vitro T cell expansion studies involving transduced T cells from healthy donors and patients, there is no evidence of transformation and immortality .

Food Interaction

No interactions found.

Tisagenlecleucel Disease Interaction

Major: hepatitis B reactivation, infections, inflammatory disorders, neurological toxicitiesModerate: vaccination

Volume of Distribution

The drug is found to be distributed in the blood as well as the bone marrow. Blood to bone marrow partitioning suggested that tisagenlecleucel distribution in bone marrow was 44% of that present in blood at Day 28 while at Months 3 and 6 tisagenlecleucel distributed at 67% and 69%, respectively, indicating high distribution to bone marrow .

Elimination Route

In pediatric and young adult relapsed/refractory B-cell acute lymphoblastic leukemia (ALL) patients receiving tisagenlecleucel infusion, the mean peak plasma concentration was approximately 34,700 copies/mcg with a median time of 9.91 days to reach this value (Tmax ) .