CAR-NK Cells for Hodgkin's Lymphoma

Overseen By Yago Nieto, MD, PHD

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: M.D. Anderson Cancer Center

Must not be taking: Steroids, Immunosuppressants, Anticancer agents, others

Disqualifiers: HIV, Active hepatitis, Active infection, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 12

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

Yago Nieto, MD, PHD

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

Inclusion Criteria

I am between 18 and 75 years old.

I have at least one cancer lesion confirmed by a PET/CT scan.

I am able to care for myself and do light activities.

Exclusion Criteria

I still have severe side effects from previous treatment.

I have not had major surgery in the past 4 weeks.

I do not have active hepatitis B, hepatitis C, HIV, or a serious infection needing IV antibiotics.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Cycle 1

Participants receive lymphodepleting chemotherapy followed by infusion of TGFBR2 KO CAR27/IL-15 NK cells

6 days

Inpatient admission starting day -6

Treatment Cycle 2

Participants receive a second cycle of lymphodepleting chemotherapy followed by infusion of TGFBR2 KO CAR27/IL-15 NK cells

6 days

Inpatient admission starting day -6

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 1 year

What Are the Treatments Tested in This Trial?

Interventions

• TGFBR2 KO CAR27/IL-15 NK cells

How Is the Trial Designed?

Group I: Cycle 2: Treatment with Fludarabine and Cyclophosphamide + TGFBR2 KO CAR27/IL-15 NK Cells Experimental Treatment 3 Interventions

Each treatment cycle will consist of lymphodepleting chemotherapy, followed by infusion of the TGFBR2 KO CAR27/IL-15 NK cells. Participants will be admitted to the inpatient service on day -6.

Group II: Cycle 1: Treatment with Fludarabine and Cyclophosphamide + TGFBR2 KO CAR27/IL-15 NK Cells Experimental Treatment 3 Interventions

Each treatment cycle will consist of lymphodepleting chemotherapy, followed by infusion of the TGFBR2 KO CAR27/IL-15 NK cells. Participants will be admitted to the inpatient service on day -6.

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+