KCAT19 T cells for relapsed or refractory B cell cancers

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

KCAT19 is a Phase I, non-randomised, open-label trial conducted at a single centre. It uses allogeneic cord blood–derived T cells engineered to express CAR19 and TCR-KDEL to target CD19 on malignant B cells. Manufacturing takes about 15 days, after which the cells are shipped in a temperature-controlled system to the treatment site for administration. The study aims to establish safety and to gather initial data on anti-tumor activity in adults aged 16–65 with relapsed/refractory B cell malignancies who have had at least two prior therapies.

Why it matters

Who can join: the full rules

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

Where it's running

• University College London Hospital
  London, United Kingdom Recruiting

Study contacts

• Study coordinator: David Gear
• Email: ctc.kcat19@ucl.ac.uk
• Phone: 0207 670 5748

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.