Approved treatment — US, Europe and Japan, for blood cancers including B-cell lymphoma, B-cell acute lymphoblastic leukemia and multiple myeloma
The CAR-T therapy process runs in six steps: consultation and tests, white blood cell collection by apheresis (3–6 hours), 3–6 weeks of cell manufacturing, a few days of lymphodepleting chemotherapy, a single intravenous infusion (10–30 minutes), and 1–2 weeks in hospital followed by about 2 weeks staying near the center. In June 2025 the US FDA shortened the required stay near the treatment center from four weeks to two and the driving restriction from eight weeks to two. In Japan, five CAR-T products for lymphoma, leukemia and multiple myeloma are approved and given under public health insurance.
What is CAR-T therapy: your own T cells fitted with a cancer-finding receptor
CAR-T (chimeric antigen receptor T cell) therapy collects a patient's own T cells, adds a gene in the laboratory so the cells carry a receptor (CAR) that recognizes a marker on cancer cells such as CD19 or BCMA, and returns them to the body. Once infused, the CAR-T cells multiply on their own and attack the cancer, so in most cases treatment is a single infusion.
Unlike chemotherapy given in repeated cycles, CAR-T has a long preparation period and needs close monitoring for several weeks after infusion. Planning the schedule and accommodation early makes the process much easier. For how it differs from NK cell therapy and TIL, see our comparison of immune cell therapies.
CAR-T therapy process: six steps at a glance
| Step | What happens | Time |
|---|---|---|
| 1. Consultation and tests | Eligibility review; heart, lung, infection and imaging tests | A few days after the first visit |
| 2. Apheresis | Blood is drawn through an arm vein or central line and only white cells (T cells) are collected | 3–6 hours, usually one day |
| 3. Manufacturing | CAR gene added and cells expanded at a manufacturing site; bridging therapy if needed | 3–6 weeks (UCLH: at least 4–6 weeks) |
| 4. Lymphodepletion | Mild chemotherapy so the CAR-T cells can settle in | A few days, starting about 1 week before infusion |
| 5. CAR-T infusion | Finished cells given once through a vein | 10–30 minutes |
| 6. Monitoring and recovery | Daily checks of fever, blood pressure and neurological signs in hospital, then staying near the center | 1–2 weeks in hospital; 2 weeks near the center after infusion (US) |
Sources: UCLH and Blood Cancer UK (UK), Washington University Cellular Immunotherapy Center (US) patient guides, US FDA labeling change of June 2025 (reported by RAPS). Actual schedules vary by product, hospital and patient.
Step by step
Step 1 Consultation and tests: checking that you are fit for treatment
A hematologist reviews the diagnosis, the number of previous treatments and the timing of relapse to decide whether CAR-T is suitable. Blood and urine tests, a heart ultrasound, lung function tests and CT or PET scans follow. Washington University notes that a bone marrow biopsy may also be done.
Step 2 Apheresis: collecting white blood cells
An apheresis machine draws blood, separates the white cells and returns the rest. Blood Cancer UK describes it as a few hours, and UCLH as around six hours including checks before and after. If arm veins are small, a central line may be placed first. Bring something to read or listen to.
Step 3 Manufacturing: keeping the disease under control while you wait
The collected cells are frozen and sent to a manufacturing site, where the CAR gene is added and the cells are expanded and tested before returning to the hospital. If the disease may grow quickly in the meantime, the team gives bridging therapy with chemotherapy or radiation. Washington University says collection takes place about 30 days before the planned infusion.
Step 4 Lymphodepleting chemotherapy: making room for the new cells
Once the cells are ready, drugs such as fludarabine and cyclophosphamide are given for a few days to lower existing lymphocyte counts, which helps the CAR-T cells expand. Blood Cancer UK says this is given about one week before infusion.
Step 5 Infusion: short, like a transfusion
The thawed CAR-T cells are infused into a vein. UCLH says 10–20 minutes and Washington University less than 30 minutes. The infusion is brief; the weeks that follow are what matter most.
Step 6 Monitoring and recovery: staying close after discharge
Patients usually stay in hospital for 1–2 weeks after infusion (at least 14 days at UCLH), with daily checks of temperature, blood pressure and neurological function such as handwriting and speech. Since the FDA labeling change in June 2025, US patients stay near the treatment center for two weeks after infusion and avoid driving for two weeks. Some hospitals set their own rules, such as UCLH's one-hour travel limit and carer presence for 28 days, so follow your center's instructions.
Phase 3 results in patients: longer survival
| Trial | Patients | Reported results |
|---|---|---|
| ZUMA-7 (axicabtagene ciloleucel, Yescarta) | 359 patients with large B-cell lymphoma that relapsed early after or did not respond to first-line treatment | Median follow-up 47.2 months; 4-year overall survival 54.6% vs 46.0% with standard care; hazard ratio for death 0.73 |
| CARTITUDE-4 (ciltacabtagene autoleucel, Carvykti) | 419 patients with lenalidomide-refractory multiple myeloma | Median follow-up 33.6 months; median progression-free survival not reached vs 11.8 months (HR 0.29); overall survival HR 0.55 |
ZUMA-7: The ASCO Post (presented in NEJM 2023). CARTITUDE-4: The ASCO Post (updated analysis in The Lancet Oncology). A hazard ratio of 0.73 means a 27% lower risk of death than standard care.
Both trials showed longer survival when CAR-T was used at an earlier stage, which supports its use as second-line treatment in the US and Europe. See also CAR-NK vs CAR-T.
Side effects and care: close watch in the first two weeks
The best-known reaction is cytokine release syndrome (CRS), with fever, chills and low blood pressure as the CAR-T cells become active; UCLH explains that it is treated with antibody therapy. Neurological effects (ICANS) such as slurred speech or confusion are treated with steroids and other measures, which is why neurological function is checked every day in hospital.
For some months after infusion, infection risk is higher and blood counts recover gradually. Hand washing, avoiding crowds and calling the hospital promptly for any fever are the main precautions. These reactions are managed with medicines prepared in advance and a monitoring system, and treatment is limited to centers that meet set requirements.
Getting CAR-T in Japan
- Approved products: A PMDA document (as of March 2026) lists five approved CAR-T products: Kymriah, Yescarta, Breyanzi, Abecma and Carvykti. Kymriah, Japan's first CAR-T, was approved in March 2019 for B-cell acute lymphoblastic leukemia and diffuse large B-cell lymphoma.
- Insurance and cost: CAR-T is covered by Japan's public health insurance. Kymriah was listed at 33.5 million yen in 2019, and patients pay according to insurance co-payment rules. International patients should ask the hospital separately about self-pay costs.
- Treatment centers: Each product has Optimal Use Promotion Guidelines, so only hospitals meeting the requirements give it. Check that the hospital is a designated center before your consultation.
- Length of stay: From collection to post-infusion monitoring can take two to three months, so plan accommodation and caregiver schedules in advance.
Preparation and questions for your doctor
- Which CAR-T product suits my diagnosis and previous treatments?
- How many weeks from collection to infusion, and will I need bridging therapy?
- How long will I be in hospital, and how long must I stay near the center after discharge?
- Whom do I contact at night if I develop fever or confusion?
- When and with which tests will the response be checked?
Frequently asked questions
How long does CAR-T treatment take in total?
Plan for about two to three months from consultation to post-infusion monitoring: 3–6 weeks of manufacturing, 1–2 weeks in hospital after infusion and 2 weeks staying nearby. Exact schedules depend on the product and hospital.
How long is the hospital stay after CAR-T?
Usually 1–2 weeks after infusion. UCLH says at least 14 days and Washington University one to two weeks. Patients who do not yet meet discharge criteria may stay longer.
How many CAR-T infusions are needed?
Most patients receive a single infusion, because the cells multiply in the body and remain to attack cancer cells over time.
Is CAR-T covered by insurance in Japan?
Yes. The five CAR-T products approved in Japan are covered by public health insurance and given at hospitals that meet the guideline requirements. International patients should confirm costs with the hospital's international office.
Sources
- University College London Hospitals (NHS) — CAR T-cell therapy, patient information
uclh.nhs.uk
Checked: 2026-11-01 - Blood Cancer UK — Having CAR T-cell therapy
bloodcancer.org.uk
Checked: 2026-11-01 - Washington University School of Medicine, Cellular Immunotherapy Center — What to expect
cellularimmunotherapy.wustl.edu
Checked: 2026-11-01 - RAPS — FDA eliminates REMS for approved CAR-T therapies (2025-06-30)
raps.org
Checked: 2026-11-01 - The ASCO Post — Overall survival with axicabtagene ciloleucel in large B-cell lymphoma: results from ZUMA-7
ascopost.com
Checked: 2026-11-01 - The ASCO Post — Updated analysis of CARTITUDE-4: cilta-cel in lenalidomide-refractory multiple myeloma
ascopost.com
Checked: 2026-11-01 - PMDA — Approval status and post-marketing surveillance of regenerative medicine products (March 2026, Japanese document)
pmda.go.jp
Checked: 2026-11-01 - The Pharma Letter — Japanese approval of Kymriah makes it the first CAR-T cell therapy authorized in Asia / Fierce Pharma — Kymriah coverage in Japan
thepharmaletter.com · fiercepharma.com
Checked: 2026-11-01
Written by the FTH editorial team. Sources checked 2026-11-01 · Medical review: not applicable
This article is general information based on public sources and does not replace diagnosis or treatment. Please discuss treatment decisions with your medical team.
