Health Library · Safety & Quality

Is It Safe to Receive CAR-T Cell Therapy in Turkey?

Educational article · Updated 2026 · For patients, families and referring physicians

Many patients and families researching CAR-T cell therapy ask a direct question: Is it safe to receive this treatment in Turkey? The concern is understandable. Advanced cellular therapies are complex, and people often associate the highest quality with the United States or Western Europe.

The short answer is that safety depends far more on how the therapy is manufactured and delivered than on the country name alone. When CAR-T is produced under proper Good Manufacturing Practice (GMP) standards, based on a product that already has regulatory approval and clinical data, and is administered in a center experienced in cellular therapy, the safety framework can meet international expectations.

This article explains what actually determines safety, how technology transfer works, and what patients should look for when considering CAR-T in Türkiye.

What “safety” really means in CAR-T therapy

CAR-T is not a conventional drug that comes off a shelf. It is a living medicine made from a patient’s own cells. Safety therefore has several layers:

• Product quality — correct identity, viability, genetic engineering, potency and absence of contamination
• Manufacturing control — validated process, in-process monitoring and release testing
• Clinical management — experienced teams that can prevent, detect and treat cytokine release syndrome (CRS), neurologic events and infections
• Patient selection — appropriate eligibility criteria so that the expected benefit outweighs the risks

A treatment can be geographically “local” and still be high quality if these layers are in place. Conversely, even a famous brand can face problems if logistics, timing or center experience are poor.

The role of technology transfer

One important development in Türkiye is the use of technology transfer rather than starting a completely new product from early research stages.

In a technology-transfer model, a product that has already been developed, tested in clinical trials and approved by a recognized regulatory authority (in this case, the Korean Ministry of Food and Drug Safety for Anbal-cel) is brought into local GMP manufacturing. The manufacturing process, quality-control methods, analytical assays and operational know-how are transferred so that the local laboratory can reproduce the product under controlled conditions.

This is different from an early-stage domestic research program that is still collecting its first clinical data. An already-approved product carries a published clinical evidence base (efficacy and safety results) that can be examined by physicians and patients.

Quality systems: GMP is the key standard

Whether a CAR-T product is made in the United States, Europe, Korea or Türkiye, the internationally recognized benchmark for manufacturing quality is Good Manufacturing Practice (GMP) for advanced therapy medicinal products.

A proper GMP environment includes:

• Controlled cleanroom facilities
• Documented and validated manufacturing processes
• Trained personnel
• In-process controls and environmental monitoring
• Orthogonal release testing (identity, potency, genetic dose, sterility, mycoplasma, endotoxin, etc.)
• Traceability and quality management systems

When a local laboratory operates under these standards and follows a transferred, previously validated process, the geographic location of the cleanroom does not by itself determine quality. The process and the quality system do.

Clinical infrastructure matters as much as the product

Even a perfectly manufactured CAR-T product can cause serious side effects. Cytokine release syndrome, neurologic toxicity, prolonged low blood counts and infections are known risks of the therapy class.

Therefore, safety also depends on the treating hospital:

• Experience with cellular therapy and transplant-level supportive care
• Ability to monitor patients closely in the days and weeks after infusion
• Ready access to treatments for CRS (such as tocilizumab and corticosteroids) and to intensive care if needed
• Protocols for infection prevention and management
• Multidisciplinary coordination between hematology, intensive care, neurology and infectious disease teams

In the current technology-transfer pathway linked to Biruni Cell Therapy, clinical administration is organized at Biruni University Hospital in Istanbul, which is the institution with established access to this manufacturing route. Patients should always confirm the current operational status and the center’s experience directly with the hospital team.

What the published data tell us about safety

For the product at the center of the current technology-transfer effort (Anbal-cel), the main clinical safety data come from a Phase 1/2 study in relapsed/refractory large B-cell lymphoma, published in Blood in 2026.

In that study (79 patients in the safety set):

• Any-grade cytokine release syndrome occurred in 57% of patients; Grade 3 CRS in 8.9%; no Grade 4 or 5 CRS was reported
• Any-grade neurologic events occurred in 13.9%; Grade 3 or higher in 3.8%
• Serious infections occurred in 25.3% of patients
• High-grade cytopenias were common, as expected with this class of therapy

These figures are broadly consistent with the safety profile of other CD19 CAR-T products. They show that the therapy carries real risks that must be managed by experienced teams, but they do not indicate an unusual or unacceptable safety signal for the product itself.

Common misconceptions about “local” production

Several misconceptions often appear in patient discussions:

• “Local means lower quality.” Quality is determined by the process, the quality system and regulatory oversight, not by the passport of the cleanroom.
• “Only US or EU products are safe.” Several regions have approved CAR-T products under rigorous review. The origin of clinical data and the robustness of manufacturing matter more than the continent.
• “Technology transfer is just a cheaper copy.” A proper technology transfer includes process know-how, analytical methods, training and quality standards. The goal is controlled reproduction of a previously validated product.
• “If it is cheaper, it must be inferior.” Cost differences often reflect manufacturing location, logistics, labor and overhead, not necessarily a reduction in release specifications.

Practical questions patients should ask

Regardless of country, patients and referring physicians can protect safety by asking concrete questions:

• Is the product manufactured under GMP conditions?
• Is the process based on a product that already has regulatory approval and published clinical data?
• What release tests are performed before the cells are given to the patient?
• Which hospital will handle collection, infusion and monitoring?
• Does that hospital have experience managing CRS, neurologic toxicity and severe infections?
• What is the expected vein-to-vein time and how is product quality protected during that period?

Bottom line

Receiving CAR-T cell therapy in Turkey can be approached with the same standards of scrutiny that should apply anywhere in the world. Safety is not guaranteed by geography, and it is not automatically compromised by geography either.

When manufacturing follows GMP, when the product is based on an already-approved and clinically studied construct, and when treatment is delivered in a center prepared for cellular therapy toxicities, the fundamental safety framework is aligned with international practice.

Patients should still perform careful due diligence, review the clinical data of the specific product, and discuss eligibility and risks with an experienced hematology/oncology team.