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CAR.70/IL15-transduced CB-NK cells

CAR.70- Engineered IL15-transduced Cord Blood-derived NK Cells in Conjunction With Lymphodepleting Chemotherapy for the Management of Relapse/Refractory Hematological Malignances

  • RegistryNCT05092451
  • PhasePhase 1/2
  • StatusRecruiting
  • ConditionB-Cell Lymphoma
  • SponsorM.D. Anderson Cancer Center
How CAR.70/IL15-transduced CB-NK cells works1 min

The drug

What is being tested.

Primary Objective: To determine the safety, efficacy and optimal cell dose of CAR.70/IL15-transduced CB-NK cells in patients with relapsed/refractory hematological malignances. The efficacy and optimal dose will be identified for individual diseases. Secondary Objectives: * To quantify persistence of infused allogeneic donor CAR-transduced CB-derived NK cells in the recipient. * To conduct comprehensive immune reconstitution studies.

The study

How the trial runs.

The goal of this clinical research study is to learn about the safety of giving immune cells called natural killer (NK) cells with chemotherapy to patients with leukemia, lymphoma, or multiple myeloma. Immune system cells (such as NK cells) are made by the body to attack foreign or cancerous cells. Researchers think that NK cells you receive from a donor may react against cancer cells in your body, which may help to control the disease.

Live record on ClinicalTrials.gov →

Eligibility

Who the study is looking for.

  • Patients with hematological malignances with an expression of CD70 in the pre-enrollment tumor sample ≥ 10% measured by immunohistochemistry or flow cytometry.
  • Patients must meet diseases specific eligibility criteria (see below)
  • Patients at least 1 week from last cytotoxic chemotherapy at the time of starting lymphodepleting chemotherapy, except for Hydroxyurea which is allowed for peripheral blood count control in AML, CML, and MDS patients until the day prior to administration of lymphodepleting chemotherapy. Patients may continue tyrosine kinase inhibitors or other targeted therapies until up to three days prior to administration of lymphodepleting chemotherapy.
  • Localized radiotherapy to one or more disease sites is allowed prior the infusion provided that there are additional disease sites that are not irradiated to assess response
  • Karnofsky Performance Scale \> 50% for patients who are \>16 years old or Lansky score ≥50% for patients who are ≤16 years of age.
  • Adequate organ function:

Inclusion criteria as written on the registry, trimmed. The full list, with exclusions, is on the live record.

How these trials work: what Phase 1 actually is · common questions Not clinical evidence.

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