- Allogeneic T Cells Expressing T Cell Receptor-KDEL and the Chimeric Antigen Receptor CAT19 for the Treatment of Advanced CD19+ Malignancies — Recruiting • Phase I • Oncology • NCT05391490.
- What is being tested: KCAT19 evaluates allogeneic T cells engineered with dual receptors (TCR-KDEL and CAR-targeting CD19) as a novel immunotherapy for advanced, treatment-resistant B cell malignancies in a Phase I safety and efficacy study.
- Patient eligibility overview: Adults aged 16-65 years with high-risk, relapsed/refractory CD19+ B cell malignancies who have exhausted standard treatment options; this represents a population with limited alternative therapeutic avenues.
- Quick orientation before opening the registry record.
- Checking recruitment status, phase and sponsor at a glance.
- Connecting this trial to nearby guidelines, Drug Science and education.
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.
- : 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
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.