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CAR T-cell therapy

Tecartus (brexucabtagene autoleucel)

An approved treatment for Mantle Cell Lymphoma.

FDA Approved (2020)by Kite Pharma (Gilead)
Preclinical
Phase 1
Phase 2
Phase 3
Approved
2020

Drug facts

The same compound appears under different names depending on the context. Here is how to identify Brexucabtagene autoleucel wherever you encounter it, plus the key facts at a glance.

Generic name
Brexucabtagene autoleucel
Brand name
Tecartus
Drug class
CAR T-cell therapy
Manufacturer
Kite Pharma (Gilead)
How it's taken
One-time infusion into a vein

A one-time CAR T-cell infusion made from the patient's own T cells, approved for adults with relapsed or refractory mantle cell lymphoma and for adults with relapsed or refractory B-cell acute lymphoblastic leukemia. In its mantle cell lymphoma trial, 87% of evaluable patients responded and 62% had a complete remission.

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Where Brexucabtagene autoleucel fits

One of 2 CAR T-cell therapies approved for relapsed or refractory mantle cell lymphoma; Breyanzi is the other. They have not been compared in a trial, and their trials enrolled different groups.

How Brexucabtagene autoleucel works

T cells are collected from the patient's blood, engineered in a lab to carry a chimeric antigen receptor (CAR) that recognizes CD19, a protein on B cells and B-cell lymphomas, and infused back as a single dose. The CAR T cells find and kill CD19-positive lymphoma cells[1]. Before the infusion, patients get 3 days of cyclophosphamide and fludarabine chemotherapy to make room for the new cells.

Side effects and safety

What patients report
Boxed warning
Cytokine release syndrome, neurologic toxicities and secondary blood cancers, including T-cell malignancies.
Label warnings
  • Cytokine release syndrome. In 93% of mantle cell lymphoma patients, grade 3 or worse in 12%, starting a median of 4 days after infusion; treated with tocilizumab and steroids.
  • Neurologic toxicities. In 80%, grade 3 or worse in 33%, starting a median of 6 days after infusion, with or after CRS.
  • Prolonged low blood counts. Grade 3 or worse low counts can last several weeks after infusion.
  • HLH/MAS. Hemophagocytic lymphohistiocytosis or macrophage activation syndrome, a severe immune overreaction, can occur and is treated by the care team.
  • Allergic reactions. Allergic reactions can occur during the infusion, so the care team watches for them.
  • Low antibody levels. Antibody levels are monitored and replaced when needed.
  • Secondary cancers. T-cell malignancies have occurred after CD19- and BCMA-directed CAR T-cell therapies.
Most common in trials
CRSFeverEncephalopathy (confusion)Low blood pressureInfectionsFatigueFast heart rateChillsTremor
What gets monitored
  • Daily checks for at least 7 days after infusion
  • Stay near a healthcare facility for at least 2 weeks
  • No driving for at least 2 weeks
  • Blood counts and antibody levels
Report a suspected reaction to Kite at 1-844-454-KITE (5483), or FDA MedWatch at 1-800-FDA-1088, or to the FDA at 1-800-FDA-1088.
In context

Tecartus carries a boxed warning for cytokine release syndrome (CRS), neurologic toxicities and secondary blood cancers, including T-cell malignancies reported after CD19- and BCMA-directed CAR T-cell therapies[1]. In mantle cell lymphoma, CRS occurred in 93% of patients (grade 3 or worse in 12%), starting a median of 4 days after infusion, and neurologic events such as confusion, tremor and trouble speaking occurred in 80% (grade 3 or worse in 33%)[1].

Other warnings are serious infections, low blood counts lasting weeks, low antibody levels and allergic reactions[1].

This is not a complete list of side effects. Talk to your doctor or pharmacist about what to expect and when to seek medical attention.

Taking Brexucabtagene autoleucel

Tecartus is given once, as an infusion into a vein, after 3 days of cyclophosphamide and fludarabine. For mantle cell lymphoma the dose is 2 million CAR-positive T cells per kilogram, up to 200 million. The care team premedicates with acetaminophen and diphenhydramine, has tocilizumab on hand, checks the patient daily for at least 7 days, and the label advises staying near a healthcare facility and not driving for at least 2 weeks afterward[1]. In the trial, the time from cell collection to infusion was a median of 27 days.

Availability and cost

No generic available

Only available as the brand-name product.

Help paying for Tecartus

The maker of Tecartus publishes no copay card, but its support program can check your insurance and explain any help that exists. Drugmaker copay cards can't be used with Medicare, Medicaid or TRICARE, but charity funds often can. Of the 3 charity funds for Mantle Cell Lymphoma, 3 were open on October 26, 2026. Pick your insurance below to see which offers fit you.

Your insurance
From the drugmaker
Tecartus (Brexucabtagene autoleucel)
Some details not published
  • Travel help

    Support teams may help eligible patients and caregivers with treatment logistics such as transportation or lodging, subject to program criteria.

    The official page does not say who qualifies. Ask the program. · source
  • Insurance and case manager help

    Kite Konnect connects patients with certain financial assistance resources. Call 1-844-454-KITE (5483), Monday to Friday, 5 AM to 6 PM PT.

    The official page does not say who qualifies. Ask the program. · source

Good to know: The Kite Konnect home page does not describe a copay program or eligibility rules. Checked on November 2, 2026.

Checked on the drugmaker's official pages on November 2, 2026. Programs change; confirm with the program before you rely on it.

Charity funds for Mantle Cell Lymphoma

  • From a charity · Blood Cancer United (formerly The Leukemia & Lymphoma Society)
    Clinical Trials Co-Pay Fund (all blood cancers) fund
    Open

    Pays for: Insurance premiums and treatment-related copays, deductibles and coinsurance, up to $3,500 per year. Requires health insurance (any kind).

  • From a charity · Blood Cancer United (formerly The Leukemia & Lymphoma Society)
    Patient Aid Program fund
    Open

    Pays for: One-time $100 stipend for non-medical expenses (transportation, food, housing, utilities); no income or insurance requirement, up to $100 per year.

    The foundation says: “CURRENT FUND STATUS: Open. Fund is currently Open.”
  • From a charity · HealthWell Foundation
    Mantle Cell Lymphoma fund
    Open

    Pays for: Prescription copays; Medicare Part B premiums, up to $8,500 per year. Requires health insurance (any kind).

Status as each foundation showed it on October 26, 2026.

Every program and charity fund for Mantle Cell Lymphoma →

More ways to get help paying for treatment →

Insurance said no? Your Insurer Denied a Rare Disease Drug and Fewer Than 1 in 100 People Appeal, So Here Is the Playbook · 14 min read

Clinical trial results

ZUMA-2 (NCT02601313) gave a single infusion to adults with relapsed or refractory mantle cell lymphoma who had already had chemotherapy, an anti-CD20 antibody and a BTK inhibitor, a median of 3 earlier treatments. Among 60 evaluable patients, 87% responded and 62% had a complete remission; among all 74 people whose cells were collected, 80% responded[1]. The median duration of response had not been reached at a median follow-up of 8.6 months.

Development history

Tecartus was developed by Kite, a Gilead company. Its first approval, in 2020, was for relapsed or refractory mantle cell lymphoma, and adult B-cell acute lymphoblastic leukemia was added later[1]. The label notes that its REMS safety program was removed in June 2025, and it asks patients to stay near a healthcare facility for at least 2 weeks after infusion[1].

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Common questions about Brexucabtagene autoleucel

▸What is Brexucabtagene autoleucel (Tecartus)?

A one-time CAR T-cell infusion made from the patient's own T cells, approved for adults with relapsed or refractory mantle cell lymphoma and for adults with relapsed or refractory B-cell acute lymphoblastic leukemia. In its mantle cell lymphoma trial, 87% of evaluable patients responded and 62% had a complete remission.

▸How does Brexucabtagene autoleucel work?

T cells are collected from the patient's blood, engineered in a lab to carry a chimeric antigen receptor (CAR) that recognizes CD19, a protein on B cells and B-cell lymphomas, and infused back as a single dose. The CAR T cells find and kill CD19-positive lymphoma cells[1]. Before the infusion, patients get 3 days of cyclophosphamide and fludarabine chemotherapy to make room for the new cells.

▸What are the side effects of Brexucabtagene autoleucel?

Tecartus carries a boxed warning for cytokine release syndrome (CRS), neurologic toxicities and secondary blood cancers, including T-cell malignancies reported after CD19- and BCMA-directed CAR T-cell therapies[1]. In mantle cell lymphoma, CRS occurred in 93% of patients (grade 3 or worse in 12%), starting a median of 4 days after infusion, and neurologic events such as confusion, tremor and trouble speaking occurred in 80% (grade 3 or worse in 33%)[1]. Other warnings are serious infections, low blood counts lasting weeks, low antibody levels and allergic reactions[1].

▸How is Brexucabtagene autoleucel taken?

Tecartus is given once, as an infusion into a vein, after 3 days of cyclophosphamide and fludarabine. For mantle cell lymphoma the dose is 2 million CAR-positive T cells per kilogram, up to 200 million. The care team premedicates with acetaminophen and diphenhydramine, has tocilizumab on hand, checks the patient daily for at least 7 days, and the label advises staying near a healthcare facility and not driving for at least 2 weeks afterward[1]. In the trial, the time from cell collection to infusion was a median of 27 days.

▸Is Brexucabtagene autoleucel FDA approved?

Yes, Brexucabtagene autoleucel (Tecartus) is FDA approved (2020) for the treatment of Mantle Cell Lymphoma.

▸How long do you stay near the hospital after Tecartus?

At least 2 weeks. The label advises staying within reach of a healthcare facility and not driving for at least 2 weeks after the infusion[1].

First week: the care team checks for cytokine release syndrome and neurologic side effects at least daily for 7 days.

After that: watching for symptoms continues, and the label says to get care right away if they appear.

In the trial: patients stayed in the hospital until at least day 7.

Source: Tecartus prescribing information, June 2026.

Sources and references

Every factual claim on this page is drawn from the public sources listed below. Click any reference to open the original document.

  1. Kite Pharma via DailyMed · 2026-06-24. Tecartus (brexucabtagene autoleucel) suspension prescribing information. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a16108c2-7ca7-45af-965e-54bda4713022
  2. Kite Pharma. Kite Konnect patient support. https://www.kitekonnect.com/

This page is for informational purposes only and does not constitute medical advice. Drug information is sourced from public databases and peer-reviewed literature and may not reflect the most recent updates. Always discuss treatment options with your healthcare provider. Last reviewed: November 2026.

Follow Tecartus by email

We'll email you when Tecartus's FDA label changes, when the FDA acts on it, and when new trials for Mantle Cell Lymphoma open. Unsubscribe anytime.

You'll get, for Mantle Cell Lymphoma:
  • Trial Alerts, when a new trial opens or a trial changes
  • Disease Updates, FDA decisions and condition news, usually 1 or 2 emails a month
Turn either off anytime from the link in every email.
We never share your email. Unsubscribe anytime. Privacy policy · Check any health site