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

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorM.D. Anderson Cancer Center

About 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Lymphoma or ALL in CR with no measurable sites of disease.

Major surgery <4 weeks prior to first dose of study drug.

Any other severe or uncontrolled disease or condition which mightincrease the risk associated with study participation.

Any other malignancy known to be active, with the exception of treated cervical intraepithelial neoplasia and non-melanoma skincancer.

Trial design

Design model

Single group

Treatments tested in this trial

  • Fludarabine

    Drug

    Given by IV

  • TGFBR2 KO CAR27/IL-15 NK cells

    Drug

    Given by IV

  • Cyclophosphamide

    Drug

    Given by IV

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Cycle 1: Treatment with Fludarabine and Cyclophosphamide + TGFBR2 KO CAR27/IL-15 NK CellsExperimental treatment 3 interventions
Group B: Cycle 2: Treatment with Fludarabine and Cyclophosphamide + TGFBR2 KO CAR27/IL-15 NK CellsExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Safety and Adverse Events (AEs)

Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0

Time frame
Through study completion; an average of 1 year

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.