Loading
Taking immune cells, engineering or expanding them, and giving them back as a living drug.
Cell therapy covers treatments in which immune cells are taken from a patient or a donor, engineered or expanded, and given back as a living drug. CAR-T has transformed B-cell malignancies and myeloma, and solid tumours are the frontier, with TIL therapy such as lifileucel, TCR-T such as afamitresgene, CAR-T against CLDN18.2 and GPC3, armoured and logic-gated CARs, allogeneic and in vivo CAR-T delivered by targeted LNPs carrying CAR mRNA, and CAR-NK and CAR-macrophages. The section lists cell-therapy release and potency testing and is linked from CAR-T, in vivo CAR-T, TIL therapy, TCR-T, CAR-NK and CAR-macrophage, allogeneic cell therapy, CAR-T for glioma, stem cell transplantation, and the companies Autolus Therapeutics and US WorldMeds.
Cell therapies made from healthy donors in advance, so patients do not have to wait for their own cells to be engineered.
Instead of making CAR-T cells from each patient, take T cells from a healthy donor or from a stem cell line, edit them so the patient's body will not fight them, grow a huge batch and freeze it into hundreds of doses that sit on a shelf.
Making cell therapies from a healthy donor or stem-cell line in advance, so patients get an off-the-shelf product instead of waiting weeks.
Allogeneic stem cell transplantation replaces a patient's blood system with a donor's after conditioning chemotherapy, so donor immune cells hunt down leukaemia left behind. It remains the only cure for adverse-risk acute myeloid leukaemia, high-risk acute lymphoblastic leukaemia and Richter transformation, at the price of graft-versus-host disease.
Apheresis is collecting a patient's white blood cells through a machine over several hours. Every autologous CAR-T begins here, and the quality of these cells shapes the final product.
Upgraded CAR-T cells that also secrete immune boosters, resist exhaustion, or only fire when two signals are present.
Each CAR-T dose is a separate factory run for one patient: collect their T cells, activate them, add the CAR gene with a virus, grow them for a week or two, freeze, test and ship them back. The steps, the failure points and the waiting list are all here.
Autologous stem cell transplant collects the patient's own blood-forming stem cells, gives melphalan or another chemotherapy at a dose that would otherwise destroy the marrow, then returns the cells to rebuild it. It is standard consolidation in myeloma and for relapsed lymphoma, though CAR-T has displaced it in early-relapsing large B-cell lymphoma.
Putting the cancer-seeking receptor on natural killer cells or macrophages instead of T cells, which could be safer and off-the-shelf.
Instead of attacking the cancer cell, engineering T cells to strip away the scaffolding and the suppressive immune cells that protect it.
A patient's T cells are removed, given a synthetic receptor that recognises the cancer, multiplied, and put back as a living drug.
Engineered immune cells delivered directly into the brain or spinal fluid. Some children with diffuse midline glioma, a brainstem tumour with no curative treatment, have had striking, if temporary, responses.
Scheduling and tracking software that makes sure each patient's cells come back to that patient, on time.
The quality checks a CAR-T batch must pass before it can be given: sterile, correct identity, enough live CAR-positive cells, and no replicating virus.
Sealed, robot-run machines that turn a patient's blood cells into a CAR-T product with far fewer hands, clean rooms, and mistakes.
Freezing cells at minus 150 degrees and shipping them in liquid-nitrogen 'dry shippers' with tracking, so a living drug arrives alive and matched to the right patient.
Cell therapies built from a rare T-cell type that recognises stressed cancer cells without needing tissue matching, making them candidates for off-the-shelf products.
Instead of engineering T cells in a factory, an injection reprograms them inside the patient's body.
Cells or drugs that fire only when two conditions are true at once, so healthy tissue expressing just one of them is spared.
Infusions of natural killer cells from donors or cord blood, sometimes fitted with a CAR, offering an off-the-shelf alternative to CAR-T with less cytokine release.
Plasmid DNA and mRNA raw materials are the DNA templates and enzymes behind viral vectors and mRNA vaccines. They are invisible to patients but decisive for supply.
Making CAR-T cells at or near the hospital instead of shipping cells to a central factory and back.
Modern biologics plants grow cells in giant sterile plastic bags instead of steel tanks, throwing the bag away after each batch. It makes plants faster to build and switch, but it ties the whole industry to a few bag and filter makers.
Tandem transplant gives two back-to-back rounds of marrow-destroying chemotherapy, each rescued with the child's own stored stem cells, for high-risk neuroblastoma in North America. It kept more children relapse-free than one transplant in a randomised trial, but adds organ toxicity and hearing loss.
T cells engineered with a receptor that sees fragments of proteins inside the cancer cell, reaching targets CAR-T cannot.
Immune cells that have already found their way into the tumour are harvested, grown to billions, and returned.
Producing the engineered viruses that carry a CAR gene into T cells. Viral vector manufacturing is a long-standing bottleneck for cell and gene therapy.
Off-the-shelf T cells from healthy donors that recognise Epstein-Barr virus, used to treat virus-driven lymphomas after transplant; tabelecleucel was approved in Europe in 2022.
Axicabtagene ciloleucel as an option in relapsed follicular and marginal zone lymphoma. Compared with tisagenlecleucel in ELARA, the response rates are higher and the neurological toxicity substantially greater, which is the trade-off a patient and centre weigh.
The reason second-line CAR-T is offered with axicabtagene ciloleucel or lisocabtagene maraleucel rather than tisagenlecleucel. The trial is also the strongest evidence in the field that the interval between apheresis and infusion, and what is given during it, is part of the treatment rather than logistics around it.
Chemotherapy-free cellular therapy for follicular lymphoma that has stopped responding, with a toxicity profile mild enough that the treatment is deliverable outside the largest centres.
The evidence that made lisocabtagene maraleucel the CD19 CAR-T product most often chosen for older or frailer patients, because its severe cytokine release syndrome rate is a fraction of the other two products'.
One of the few maintenance strategies in lymphoma that improved overall survival rather than only progression-free survival, and the reason three years of rituximab became standard after autologous transplantation in mantle cell lymphoma.
It showed that a single academic centre outside the United States could run tumour-infiltrating lymphocyte therapy at scale and get durable remissions, and it quantified the attrition that intent-to-treat reporting exposes and single-arm treated-patient reporting hides.
Every approved CAR-T product descends from this design. It is the reason a T cell can be pointed at CD19 or BCMA at all, and the reason the question of what to point it at in solid tumours is a question about antigens rather than about the receptor.