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Not actual patients.
TECELRA is a one-time treatment made from your patient's own T cells to destroy their synovial sarcoma cells1
The TECELRA treatment process in 6 steps
TESTING|~5 days per test, from when sample is received†
-
Two different biomarker tests are required to confirm patient eligibility
- A blood test to determine appropriate HLA‑A*02 subtypes
- A tumor tissue test to detect expression of the MAGE‑A4 antigen
- To receive TECELRA, patients must test positive for HLA‑A*02:01P, ‑A*02:02P, ‑A*02:03P, or ‑A*02:06P, and negative for HLA‑A*02:05P, and have a tumor that expresses the MAGE‑A4 antigen as determined by FDA-approved or cleared companion diagnostic devices
PRE-TREATMENT|Up to 8 hours
- T-cell collection takes place at an ATC
- Collected T cells are immediately processed and shipped fresh for manufacturing within 48 hours
PRE-TREATMENT|~6-week targeted turnaround time
- At US WorldMeds' manufacturing facility, patient T cells are engineered using a lentiviral vector to target MAGE‑A4
-
TECELRA TCR T cells are cryopreserved and returned to the ATC
- TECELRA is stored in vapor phase of liquid nitrogen (≤−130°C)
PRE-TREATMENT|1 week prior to TECELRA infusion
- TECELRA must be received at the ATC prior to starting the lymphodepleting chemotherapy regimen
-
Starting 1 week before TECELRA is infused, patients receive a
chemotherapy regimen of:
- Fludarabine 30 mg/m2/day IV for 4 days
- Cyclophosphamide 600 mg/m2/day IV for 3 days
- Short-acting or pegylated G-CSF may be administered at physician discretion
TREATMENT
Premedication1
~30-60 minutes prior to TECELRA infusion
- Patients are premedicated with an H1-antihistamine and acetaminophen§
Infusion1
Up to 60 minutes per infusion bag
- TECELRA is thawed prior to administration
-
TECELRA is administered in a single infusion at the ATC
- Immediate access to medications and resuscitative equipment to manage CRS and ICANS should be ensured. Patients must be euvolemic prior to initiating TECELRA
- Serious hypersensitivity reactions, including anaphylaxis, may occur due to dimethyl sulfoxide (DMSO) in TECELRA. Observe patients for hypersensitivity reactions during infusion
- Monitor patients for signs and symptoms of infection before and after TECELRA infusion and treat appropriately
POST-TREATMENT|At least 2 weeks
- For at least 7 days following treatment with TECELRA for signs and symptoms of CRS and ICANS at the healthcare facility where treatment was administered
- For at least 2 weeks following treatment with TECELRA for signs and symptoms of CRS or ICANS
- Patients must remain within proximity of a healthcare facility for at least 2 weeks following TECELRA infusion for the required monitoring
- At the first sign of CRS or ICANS, patients should be immediately evaluated for hospitalization and administered supportive care based on severity, and further management per clinical practice guidelines should be considered
ATC=Authorized Treatment Center; CRS=cytokine release syndrome;
G-CSF=granulocyte colony-stimulating factor; HLA=human leukocyte antigen;
ICANS=immune effector cell-associated neurotoxicity syndrome;
IV=intravenous; MAGE=melanoma-associated antigen; TCR=T-cell receptor.
†Based on independent laboratory experience.3
‡Note that bridging therapy, or additional disease control treatments, may
be initiated at this time. In the clinical trial, 40% of patients (n=55)
received bridging therapy between leukapheresis and initiation of
lymphodepletion. The most commonly used bridging therapy was
pazopanib (45%).1
§Avoid prophylactic systemic corticosteroids, as they may interfere with
the activity of TECELRA.1
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