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

Summary

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.

Eligibility

Inclusion Criteria:

1. Age 16-65 years
2. Relapsed or refractory B cell malignancy following at least 2 prior lines of therapy:

   B-ALL: relapsed or refractory B-ALL following standard therapy, requiring salvage, in whom alternative therapies are deemed inappropriate by their treating physician Or LBCL: relapsed/refractory DLBCL (incl. transformed FL but not Richter's transformation) or PMBCL following ≥2 prior lines of therapy which must include Rituximab, anthracycline and autologous CD19 CAR, (unless CD19 CAR cannot be manufactured) Or MCL: relapsed/ refractory disease following ≥2 lines of therapy which must include Rituximab, Bruton's tyrosine kinase inhibitor and autologous CD19CAR therapy (unless CD19 CAR cannot be manufactured) Or Indolent B-NHL (either Follicular Lymphoma, Marginal Zone Lymphoma or other low-grade lymphoma) which is relapsed / refractory following ≥2 prior lines of therapy which must include anti-CD20 therapy and chemotherapy with anthracycline or bendamustine.
3. CD19+ disease
4. Agreement to have a pregnancy test, use adequate contraception (if applicable)
5. Written informed consent

Exclusion Criteria:

1. CD19 negative disease
2. Active CNS involvement of disease
3. Diagnosis of chronic lymphocytic leukaemia/ small lymphocytic lymphoma or Burkitt lymphoma
4. Active hepatitis B, C or HIV infection
5. Oxygen saturation ≤ 90% on air
6. Bilirubin \>2 x upper limit of normal
7. GFR \<30ml/min
8. Women who are pregnant or breast feeding
9. Stem Cell Transplant patients only: active significant acute GvHD (overall Grade ≥ II, Modified Glucksberg criteria) or moderate/severe chronic GvHD (NIH consensus criteria) requiring immunosuppressive therapy and/or systemic steroids
10. Karnofsky score \<60%
11. Known allergy to albumin or DMSO
12. Patients receiving corticosteroids at a dose of \>5 mg prednisolone per day (or equivalent) that cannot be discontinued
13. Life expectancy \<3 months
14. Cardiac dysrhythmias (excluding well-controlled AF or other supraventricular tachycardia) or significant cardiac disease and left ventricular ejection fraction \<40%
15. Patients who can reasonably access autologous CD19 CAR treatment as part of standard of care or a clinical trial\*

    * These patients will be initially considered for autologous treatment in preference to enrolling on KCAT19

Conditions2

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