Status:
NOT_YET_RECRUITING
Allogeneic T Cells Expressing T Cell Receptor-KDEL and the Chimeric Antigen Receptor CAT19 for the Treatment of Advanced CD19+ Malignancies
Lead Sponsor:
University College, London
Conditions:
Blood Cancer
Eligibility:
All Genders
16-65 years
Phase:
PHASE1
Brief 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/refra...
Detailed Description
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...
Eligibility Criteria
Inclusion
- Age 16-65 years
- 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.
- CD19+ disease
- Agreement to have a pregnancy test, use adequate contraception (if applicable)
- Written informed consent
Exclusion
- CD19 negative disease
- Active CNS involvement of disease
- Diagnosis of chronic lymphocytic leukaemia/ small lymphocytic lymphoma or Burkitt lymphoma
- Active hepatitis B, C or HIV infection
- Oxygen saturation ≤ 90% on air
- Bilirubin \>2 x upper limit of normal
- GFR \<30ml/min
- Women who are pregnant or breast feeding
- 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
- Karnofsky score \<60%
- Known allergy to albumin or DMSO
- Patients receiving corticosteroids at a dose of \>5 mg prednisolone per day (or equivalent) that cannot be discontinued
- Life expectancy \<3 months
- Cardiac dysrhythmias (excluding well-controlled AF or other supraventricular tachycardia) or significant cardiac disease and left ventricular ejection fraction \<40%
- 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
Key Trial Info
Start Date :
October 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2034
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT05391490
Start Date
October 1 2022
End Date
November 1 2034
Last Update
May 26 2022
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