All therapies
CD19-directed Developed & approved in China NMPA-approved 2025

CNCT19

Inaticabtagene autoleucel

A CD19-targeted CAR T-cell therapy for certain relapsed or refractory B-cell cancers — including large B-cell lymphoma and B-cell acute lymphoblastic leukemia. Made from your own immune cells, delivered at SinoUnited Health in Shanghai.

Also known as CNCT19 · inaticabtagene autoleucel · CD19-directed autologous CAR-T

See the full treatment journey
What it is

A therapy made from your own cells.

A plain-language look at what CNCT19 is and how it works — general to this class of therapy, not specific to any one patient's result.

Inaticabtagene autoleucel — CNCT19 for short — is a type of CAR T-cell therapy. Your own T-cells (part of your immune system) are collected, then re-engineered to recognize a protein called CD19 that sits on the surface of B-cells. Once returned to your body, these modified cells seek out and destroy the cancerous B-cells.

It is an autologous therapy, meaning it is made from your own cells rather than a donor's. CNCT19 is a CD19-directed CAR T-cell therapy developed in China and approved by China's National Medical Products Administration (NMPA). Its large B-cell lymphoma indication was approved on 28 November 2025, and it is also approved in relapsed or refractory B-cell acute lymphoblastic leukemia.

Approved indications

NMPA · verbatim label
  1. Adult Relapsed or Refractory B-cell Acute Lymphoblastic Leukemia (r/r B-ALL) CNCT19 is indicated for the treatment of adult patients with relapsed or refractory B-cell acute lymphoblastic leukemia (r/r B-ALL). This indication has received conditional approval. Additional data on efficacy and safety will be provided through post-launched studies.
  2. Adult Relapsed or Refractory Large B-cell Lymphoma (r/r LBCL) CNCT19 is indicated for the treatment of adult patients with relapsed or refractory large B-cell lymphoma (r/r LBCL) after two or more lines of systemic therapy, including:
    • Diffuse large B-cell lymphoma, not otherwise specified (DLBCL-NOS)
    • Large B-cell lymphoma transformed from follicular lymphoma (tFL)
    • Primary mediastinal large B-cell lymphoma (PMBCL)

Eligibility depends on your specific diagnosis — see the condition page.

How it works

How CNCT19 is given.

CNCT19 follows the same CAR T-cell pathway as other therapies of its class — offered at SinoUnited as an all-inclusive “2+21” package across two trips to Shanghai, with the manufacturing weeks spent at home.

Diagram of the CAR T-cell process: blood is drawn, T-cells are re-engineered in the lab to express a CAR protein, grown in number, infused into the patient, and the CAR T-cells bind to and destroy cancer cells.
The CAR T-cell process, in five steps — from cell collection to the engineered cells binding the target antigen.
Stage 01

Collection

Blood and eligibility tests, then your T-cells are collected by apheresis — both done on-site at SinoUnited Health.

Trip one · ~1 week, Shanghai
Stage 02

Manufacturing

Your cells are engineered to target CD19 and expanded while you return home and wait.

3–4 weeks · at home
Stage 03

Lymphodepletion

A short course of chemotherapy prepares your body to receive the engineered cells.

Trip two · Shanghai
Stage 04

Infusion & recovery

Your CNCT19 is returned in a single infusion, followed by close inpatient monitoring.

Trip two · ~3 weeks, Shanghai

The full pathway at SinoUnited spans approximately two months across two trips to Shanghai, with the manufacturing period spent at home. See the patient journey for the detail.

Who it's for

Where CNCT19 may be an option.

Eligibility is set honestly here as a general guide — the decision itself rests with a qualified physician who has reviewed your case.

  • Adults with relapsed or refractory large B-cell lymphoma, or patients with relapsed or refractory B-cell acute lymphoblastic leukemia — disease that has returned, or has not responded to previous treatment.
  • Typically considered after earlier lines of therapy; the exact prior-treatment requirement depends on your diagnosis and the approved indication.
  • A good level of general fitness (ECOG 0–1) is usually needed.

Eligibility depends on your specific diagnosis — see the condition page. This is a general guide only; whether CNCT19 is right for you is a decision made by a qualified physician after reviewing your individual case.

What it treats

For two B-cell cancers.

CNCT19 is directed at CD19, a protein expressed on the surface of B-cells — the lineage from which both of these cancers arise.

CD19-targeted · approved 28 Nov 2025

Large B-cell lymphoma

Cancer of
B-cells (a type of lymphocyte)
Incidence
Most common aggressive lymphoma
Considered at
Relapsed / refractory disease

Large B-cell lymphoma (LBCL) is an aggressive cancer of the B-cells. Diffuse large B-cell lymphoma (DLBCL) is its dominant subtype and the term most patients search for — the approval is written for LBCL, and DLBCL falls within it.

For disease that has relapsed or become refractory after earlier treatment, CD19-directed CAR T-cell therapy is an established option, targeting the CD19 protein carried on the surface of the cancerous B-cells.

DLBCL details
CD19-targeted

B-cell acute lymphoblastic leukemia

Cancer of
Immature B-cells, in the bone marrow
Incidence
Most common childhood leukemia; also in adults
Considered at
Relapsed / refractory disease

B-cell acute lymphoblastic leukemia (B-ALL) is a fast-growing cancer of immature B-cells in the bone marrow. It is treated with intensive chemotherapy, but can return or stop responding.

For relapsed or refractory disease, CD19-directed CAR T-cell therapy targets the CD19 protein expressed on the leukaemic B-cells.

B-ALL details
Safety & side effects

Managed with close monitoring.

Two blocks, kept deliberately separate: what is true of this class of therapy in general, and what SinoUnited provides.

General to CAR T-cell therapy

CRS and neurological effects

Like all CAR T-cell therapies, CNCT19 can cause side effects that need close monitoring. The two most discussed are cytokine release syndrome (CRS) — the immune system reacting as the therapy works — and neurological effects (ICANS). Most cases are manageable when caught early, which is why treatment is delivered as an inpatient stay with continuous monitoring.

At SinoUnited Health

Supervised, with intensive care on hand

SinoUnited Health provides infusion and recovery as a supervised inpatient stay in 100-level laminar-flow rooms, with on-site intensive care available if escalation is ever needed.

Tocilizumab, the standard treatment for severe cytokine release syndrome, is available on site.

5on-site ICUs
Why SinoUnited

A published hematologist.

SinoUnited's CAR-T program has Dr. Lily Zhou, M.D., Ph.D., Chief of Hematology — with a postdoctoral fellowship at UCSF and 25 publications indexed in PubMed, working within the Shanghai Ruijin Consortium of Blood Disease. CNCT19 is delivered as part of that program.

Any results, once published, describe the patients they concern — they are not, and must not be read as, a prediction of outcomes for any individual. Outcomes vary and are determined by individual circumstances.

Meet Dr. Zhou
Dr. Lily Zhou, Chief of Hematology at SinoUnited Health, in a white clinical coat.
Dr. Lily Zhou, M.D., Ph.D. Chief of Hematology
Cost

One all-inclusive package.

2 + 21days, across two stays

SinoUnited offers CAR-T as an all-inclusive “2+21” package — covering the collection stay and the three-week infusion stay. The full breakdown of what's included, and pricing, lives on the Costs page as a single source of truth.

Questions

Common questions.

Is CNCT19 available in my country?

It is delivered at SinoUnited Health in Shanghai. Both collection and infusion are done on-site — they cannot be carried out in your home country.

How long does the whole process take?

About two months across two trips to Shanghai, with the four-to-six-week manufacturing period spent at home in between.

What does it cost?

CAR-T is offered as one all-inclusive “2+21” package. The full cost breakdown is set out on the Costs page.

What are the side effects?

The most discussed are cytokine release syndrome (CRS) and neurological effects (ICANS), which is why treatment is delivered as a monitored inpatient stay. SinoUnited-specific detail will be added once confirmed by Dr. Zhou.

Can my hematologist at home stay involved?

Yes. SinoUnited coordinates follow-up with your local physicians, with three-monthly reviews recommended after treatment.

Eligibility

Not sure if CNCT19 is an option?

Start a remote assessment before you travel. It asks only for basic contact details and your diagnosis — your records are then reviewed by Dr. Zhou's hematology team.