Photo image of an adult female walking with her father along a path through a field of wildflowers, followed by an engineered mechanical yellow and magenta butterfly

The TECELRA treatment process is engineered to change how you treat advanced SyS

Not actual patients.

A single infusion of TECELRA is administered in a process that is similar to other cell therapies1

TECELRA is a one-time treatment that requires pre-treatment and post-treatment steps1

Pre-treatment, treatment, and post-treatment steps
1 Testing 2 Leukapheresis 3 Manufacturing 4 Lymphodepletion 5 Infusion 6 Monitoring
Image of an engineered mechanical yellow and magenta butterfly
TESTING
Illustrated icon of a test tube and microscope slide plate step1

Testing for Biomarkers1-3

(~5 days per test, from the time 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 the MAGE‑A4 antigen
  • To receive TECELRA, adult 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
Image of an engineered mechanical yellow and magenta butterfly
PRE-TREATMENT

Leukapheresis1,3,4,‡

(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
Illustrated icon of an apheresis machine surrounded by illustrated blood cells step2
Illustrated icon of a T cell and arrows pointing to an enhanced T cell step3

Manufacturing1

(~6-week targeted turnaround time)
  • At Adaptimmune's 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)

Lymphodepleting chemotherapy1

(1 week prior to TECELRA infusion)
  • TECELRA must be received at the healthcare facility prior to starting the lymphodepleting chemotherapy regimen
  • Starting 1 week before TECELRA is infused, patients receive a chemotherapy regimen of:
    • Fludarabine for 4 days
    • Cyclophosphamide§ for 3 days
Illustrated icon of a chemotherapy IV bag step4
Image of an engineered mechanical yellow and magenta butterfly
TREATMENT
Illustrated icon of a human silhouette attached to an IV bag with TECELRA symbol in yellow and magenta step5

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
Image of an engineered mechanical yellow and magenta butterfly
POST-TREATMENT

monitoring1

(at least 4 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 4 weeks following treatment with TECELRA for signs and symptoms of CRS and ICANS
  • Patients must remain within proximity of a healthcare facility for at least 4 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
Illustrated icon of magnifying glass step6
Image of an engineered mechanical yellow and magenta butterfly
Find an ATC
near you
ATC=Authorized Treatment Center; CRS=cytokine release syndrome; HLA=human leukocyte antigen; ICANS=immune effector cell-associated neurotoxicity syndrome; MAGE=melanoma-associated antigen; SyS=synovial sarcoma; 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, 36% of patients (n=16) received bridging therapy between leukapheresis and the initiation of lymphodepletion. The most common bridging therapy used in 69% of patients was pazopanib.1
§ With an optional dose of mesna to prevent hemorrhagic cystitis.5
|| Avoid prophylactic systemic corticosteriods, as they may interfere with the activity of TECELRA.1
More info about TECELRA
Illustrated icon of a test tube, microscope slide plate, and checklist Learn about biomarker testing for eligibility Illustrated icon of a magnifying glass looking at a graph See the response rates from the clinical trial Illustrated icon of a safety shield Review safety from the clinical trial