CAR.70 / IL-15 / TGFBR2-Knockout Cord Blood NK Cells

Primary Objective: To establish the safety of TGFBR2 KO CAR27/IL-15 NK cells in patients with R/R lymphomas and B-ALL through the following primary endpoints * To determine the recommended phase 2 dose (RP2D) of this treatment. * To define the dose-limiting toxicity (DLT) of this treatment. Secondary Objectives: 1.

To observe and record anti-tumor activity through the following secondary endpoints: * Day+ 30 complete response (CR) rate. * Day +30 overall response rate (ORR). * Day 180 progression-free survival rate 2. To quantify the persistence of infused donor TGFBR2 KO CAR27/IL-15 NK cells in the recipient. 3. To conduct comprehensive immune reconstitution studies. 4. To obtain preliminary data on quality of life (QOL) and patient experience

This is a phase 1 basket trial of TGFBR2 KO CAR27/IL-15 NK cells after lymphodepleting chemotherapy for patients with R/R B-NHL, HL, T-NHL or B-ALL.

Registro actualizado en ClinicalTrials.gov →

• 18-75 years of age.
• B-NHL: Failure of >/= 1 salvage line and failure of or ineligibility for CAR-T.
• HL and T-NHL: Failure of >/= 1 salvage line or prior SCT.
• ALL: Active disease (>5% of blasts or positive MRD at a level of >0.1% measured by multiparameter flow cytometry) after ≥ 2 two lines of therapy. Patients with B-ALL must have either failed of or be ineligible for CAR-T cell therapy. Patients who have mutations for which there are FDA approved targeted therapies (i.e., BCR-ABL) must also have received at least one of such agents.
• Expression of CD70 in the pre-enrollment sample >/= 20% measured by immunohistochemistry or flow cytometry.

Criterios de inclusión tal como figuran en el registro, recortados. La lista completa, con las exclusiones, está en el registro actualizado.