NCT07444632

Phase1 Basket Trial Of CAR.70-Engineered IL15-Transduced With TGFBR2 Knock Out Cord Blood-Derived NK Cells For Relapsed/Refractory Lymphoid Malignancies

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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

Conditions

• Lymphoid
• Hodgkin Lymphoma

Interventions

Type	Name	Description
DRUG	Fludarabine	Given by IV
DRUG	TGFBR2 KO CAR27/IL-15 NK cells	Given by IV
DRUG	Cyclophosphamide	Given by IV

Timeline

• Start date: 2026-08-31
• Primary completion: 2030-09-30
• Completion: 2032-09-30
• First posted: 2026-03-03
• Last updated: 2026-03-27

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study