Actively Recruiting

Phase 1
Phase 2
Age: 12Years - 80Years
All Genders
NCT05092451

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

Led by M.D. Anderson Cancer Center · Updated on 2026-05-06

80

Participants Needed

1

Research Sites

199 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 12Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with hematological malignancies showing CD70 expression ≥ 10% in tumor samples
  • Meet disease-specific eligibility criteria
  • At least 1 week since last cytotoxic chemotherapy before starting lymphodepleting chemotherapy (except Hydroxyurea as allowed)
  • Localized radiotherapy allowed if other disease sites remain for response assessment
  • Karnofsky performance score > 50% if >16 years old or Lansky score ≥ 50% if ≤16 years old
  • Adequate organ function: renal, hepatic, cardiac, and pulmonary as specified
  • Able to provide written informed consent
  • Age between 12 and 80 years
  • Weight of at least 40 kg
  • Effective birth control for participants able to have children during study and 3 months after
  • Signed consent for long-term follow-up
  • Willing and able to provide informed consent or through a legally authorized representative
Not Eligible

You will not qualify if you...

  • Positive pregnancy test in females of childbearing potential or lactating females
  • Grade 3 or higher toxicity from previous treatment
  • Uncontrolled infections not responding to therapy
  • HIV with detectable viral load
  • Active neurological disorders
  • Autoimmune disease within past 12 months
  • Amyloidosis or POEMS syndrome
  • Active brain or meningeal involvement by cancer
  • Active acute or chronic graft-versus-host disease requiring therapy
  • Other active malignancies except certain treated skin or cervical conditions
  • Serious medical conditions deemed unsafe by investigator
  • Major surgery within 4 weeks before chemotherapy
  • Allogeneic stem cell transplant or donor lymphocyte infusion within 12 weeks before chemotherapy
  • Use of other investigational or anti-cancer agents
  • Systemic steroid therapy at time of NK cell infusion (except physiological doses)
  • Recent use of antithymocyte globulin, lymphocyte immune globulin, or alemtuzumab
  • Use of immunosuppressive therapy

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

M D Anderson Cancer Center

Houston, Texas, United States, 77030

Actively Recruiting

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Research Team

D

David Marin

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

3

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