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

Launched by UNIVERSITY COLLEGE, LONDON · May 20, 2022

Keywords

ClinConnect Summary

This clinical trial, called KCAT19, is testing a new treatment for adults aged 16 to 65 who have advanced blood cancers, specifically certain types of B cell malignancies that have not responded to previous treatments. The goal is to see if a special type of immune cell therapy—using T cells that have been engineered to recognize cancer cells—can help patients whose cancers have returned or have not improved after at least two different therapies. The trial is not yet recruiting participants, but it aims to include individuals with specific types of cancer that express a protein called CD19.

To be eligible for the trial, participants must be between 16 and 65 years old and have a specific type of B cell cancer that has not responded to prior treatments. They must also be able to provide written consent and, if applicable, agree to use contraception during the study. Participants will undergo tests and assessments to ensure their health is stable enough for the treatment, and they can expect close monitoring throughout the trial. This study is important for exploring new options for patients with limited treatment choices and could help advance the understanding of therapies for blood cancers.

Gender

ALL

Eligibility criteria

• 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