Introduction:

CD19 CART cell therapy has emerged as an effective treatment option for many patient with Relapsed/Refractory None Hodgkin lymphoma. In the Gulf region we at Abu Dhabi Stem cell Centre (ADSCC) where first to establish our in house manufactured CD19 CART and treat patients with R/R NHL not only eliminating the need to travel abroad but also reducing cost, offer treatment to patient unable to travel and giving therapy in a reasonable time frame.

We presented our initial Data last year and here we present the 1 yr median follow up for our first 5 cases and persistence data and updates on our 12-patient treated with locally manufactured CD19 CART cell product in United Arab Emirates (UAE)

Method

Leukapheresis was performed using the Spectra Optia® system to collect cells containing 2.0 × 10⁹ CD3+ T cells via peripheral venous access. From this, approximately 100 × 10⁶ CD3+ T cells were isolated and genetically modified in a GMP-compliant lab using the CliniMACS Prodigy® system with a CD19-specific CAR lentiviral vector. Quality control throughout the process included sterility testing, flow cytometry for cell analysis, and vector copy number assessment. After lymphodepletion with Fludarabine (25 mg/m² for 3 days) and Cyclophosphamide (1000 mg/m² for 1 day), a single infusion of 3.0 × 10⁶ CD19 CAR-T cells per kg was given. CAR-T cell levels in the blood were monitored over time using flow cytometry to assess expansion and persistence. Treatment response was evaluated on day 28 using Lugano 2014 criteria, and side effects such as CRS and ICANS were graded according to 2018 ASTCT guidelines.

Results

To date 12 ( 8 males and 4 Females) received treatment (December 2023 – March 2025) 5 patients have median follow up of 1 yr. Average age 54 (40-70). Median International prognostic factor at diagnosis 3 (IPI 1-4), 11 patients were diagnosed with R/R DLBCL 1of them was transformed follicular lymphoma and 1 patient was R/R mantel cell lymphoma. Median number of therapies received was 2 ( 2-4 ) and 3 out of the 12 has prior ASCT. 3 patients require CVC for collection rest peripheral blood. median CAR-T production time was 11 (8-12) days with median transduction efficiency of 39.3% ( 36.7-53.9). 10 patients received fresh product. Median infusion time was 12 days vein to vein ( 11-13). Of the 12 patients all had CRS grade 1, no CRS (Cytokines Release syndrome) grade 2 or more and no ICANS (Immune effector cell associated neurotoxicity) observed. Only 3 patients required 1-unit PRBC during neutropenic phase and no platelet transfusion required. Median hospital stay during neutropenic phase was 14 ( 11-18).

At day 30+ 9 achieved CMR, 2 PR and 1 local progressive disease treated with radiotherapy. 11 patients are currently in CMR. OS 1 yr is 100% for the 5 patients. 1 patients has progressive disease receiving therapy.

CAR-T cell persistence in peripheral blood typically follows a biphasic kinetic pattern. The process begins with a proliferation phase, during which CAR-T cells expand with an average level of 14.81% ± 12.25. This expansion reaches its peak between days 10 and 14 post-infusion, with a mean peak level of 55.43% ± 12.52 CAR-T cells. Following this peak, a contraction phase occurs, during which CAR-T cell numbers decline to an average of 17.99% ± 14.31. Subsequently, CAR-T cells may enter a dormant or memory-like phase, characterized by low-level persistence, with an average frequency of 2.12% ± 0.30

Conclusions

Our locally produced CD19 CAR-T cell therapy for relapsed or refractory high-grade B-cell lymphoma demonstrates durable safety and efficacy. The platform supports rapid vein-to-vein delivery, and we report, region-first CAR-T cell persistence data and kinetics. Our findings support the promise of locally manufactured CAR-T platforms that offer timely access, strong safety profiles, and encouraging early signals of long-term benefit.

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2025
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