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Treatment with Lymphodepletion followed by a dose of KCAT19 T cells.

Allogeneic, cord unit derived KCAT19 T cells

KCAT19 T cells

David Gear

Alex Day

KCAT19 is a single-centre, non-randomised, open-label Phase I clinical trial of an Advanced Therapy Investigational Medicinal Product (ATIMP) in adults (age 16-65 years) with high risk, relapsed/refractory (r/r) B cell malignancies.

The aims of this study are to make sure these KCAT19 T cells can be made in the lab, assess if these therapies are safe and also obtain some initial information that these CAR T cells work in patients with B-cell malignancies.

Following patent's informed consent and registration into the trial, allogeneic HLA-matched cord blood donor T cells will be couriered to the Centre for Cell, Gene \& Tissue Therapeutics (CCGTT) at the Royal Free Hospital (RFH) where the KCAT19 T cells will be manufactured. The first 3 patients treated on KCAT19 will be HLA matched 4-6/6 with a cord-blood donor and the remaining patients registered will be HLA matched 0-6/6 if confirmed by the IDMC.

KCAT19 T cells are classified as advanced therapy investigational medicinal products (ATIMPs) and manufacture will take approximately 15 days.

Briefly, the allogeneic cord-blood derived T cells are grown in the presence of a lentivirus which transfers specific genes into the T cells (part of the white blood cells). The genes enable the T cells to express a protein which can recognise a target protein (CD19) present on the surface of the malignant B-cells and attack them. The genetically modified cells are tested to ensure they comply with the specified quality release criteria and frozen at RFH. The ATIMPs are couriered to the trial site with a special shipper (maintaining temperature below -130C) to be administered to the patient when needed. During the ATIMP manufacturing period, patients may receive "holding" chemotherapy or immunotherapy as per institutional practice to maintain disease control. Prior to infusion of the KCAT19 T cells, patients will be admitted to hospital to have pre-conditioning therapy with 2 anticancer drugs: cyclophosphamide and fludarabine.

Patients will then receive the KCAT19 T cell infusion on day 0. The KCAT19 T cells are given as an intravenous infusion. Patients will be closely monitored at the participating trial site for a minimum of 14 days after the KCAT19 T cells infusion with regular observations and blood tests (detailed in the protocol) to assess for potential toxicities. Disease assessment will take place at; baseline, month 1, month 6 and month 12 post-KCAT19 T cell infusion.

Following discharge, patients will be followed up monthly for the first 6 months, then 6 weekly until 12 months post KCAT19 T infusion, followed by quarterly visits for a further year before annual visits until the end of the trial is declared (Year 3 - Year 10).

Single-centre, non-randomised, open-label Phase I clinical trial of an Advanced Therapy Investigational Medicinal Product (ATIMP)

Allogeneic T Cells Expressing T Cell Receptor-KDEL and the Chimeric Antigen Receptor CAT19 for the Treatment of Advanced CD19+ Malignancies

Feasibility of generation of T cell receptor-negative KCAT19 T cells as evaluated by the number of therapeutic products generated.

Toxicity following KCAT19 T cell administration as evaluated by the incidence of grade 3-5 toxicity causally related to the ATIMP

Proportion of responders and depth of response at 1 and 6 months post ATIMP infusion

Persistence and frequency of circulating KCAT19 T cells in peripheral blood as assessed by flow cytometry

Persistence and frequency of circulating KCAT19 T cells in peripheral blood as assessed by qPCR

Incidence and duration of hypogammaglobulinaemia and B cell aplasia

Event-Free Survival at 1 and 2 years after immunotherapy with KCAT19 T cells

Overall survival at 1 and 2 years after immunotherapy with KCAT19 T cells

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Allogeneic T Cells Expressing T Cell Receptor-KDEL and the Chimeric Antigen Receptor CAT19 for the Treatment of Advanced CD19+ Malignancies	NCT05391490	Blood Cancer	KCAT19 T cells	16 Years - 65 Years	University College, London
Allogeneic T Cells Expressing T Cell Receptor-KDEL and the Chimeric Antigen Receptor CAT19 for the Treatment of Advanced CD19+ Malignancies	NCT05391490	Blood Cancer	KCAT19 T cells	16 Years - 65 Years	University College, London

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