Phase I clinical trial: authors generated T-cells specific for κ-light chain (CAR.κ) to selectively target κ+ lymphoma/leukemia cells.
T cells generated by activating autologous PBMC with immobilized OKT3 (n=5) or CD3/CD28 monoclonal antibodies (n=8).
Treatment well tolerated, without side effects.
Persistence of infused T cells assessed in blood by CAR.κ-specific Q-PCR assay and peaked 1 to 2 weeks post infusion, remaining detectable for 6 weeks to 9 months.
2/5 with relapsed NHL entered complete remission (after 2 and 3 infusions at dose level 1 and 3, respectively), 1/5 had a partial response and 2 progressed;
3/3 patients with MM have had stable disease for 2, 8 and 11 months, associated with up to 38% reduction in their paraprotein.
2/2 patients with CLL progressed before or shortly after the 6-week evaluation.