Actively Recruiting

Phase 1
Phase 2
Age: 18Years +
All Genders
NCT05110742

Phase I/II Study of CD5 CAR Engineered IL15-Transduced Cord Blood-Derived NK Cells in Conjunction With Lymphodepleting Chemotherapy for the Management of Relapsed/Refractory Hematological Malignances

Led by M.D. Anderson Cancer Center · Updated on 2026-02-02

64

Participants Needed

1

Research Sites

192 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

To determine the safety, efficacy and optimal cell dose of CAR 5/IL15-transduced CB-NK cells in patients with relapsed/refractory T-cell malignances, mantle cell lymphoma, and chronic lymphocytic leukemia. The efficacy and optimal dose will be identified for individual diseases.

CONDITIONS

Official Title

Phase I/II Study of CD5 CAR Engineered IL15-Transduced Cord Blood-Derived NK Cells in Conjunction With Lymphodepleting Chemotherapy for the Management of Relapsed/Refractory Hematological Malignances

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with hematological malignancies showing CD5 expression ≥ 30% in tumor samples by immunohistochemistry or flow cytometry
  • Meet disease-specific eligibility criteria
  • At least 1 week since last cytotoxic chemotherapy before starting lymphodepleting chemotherapy
  • Localized radiotherapy allowed before infusion if additional non-irradiated disease sites exist
  • Karnofsky Performance Scale score over 50%
  • Adequate organ function: renal, hepatic, cardiac, and pulmonary as defined in protocol
  • Able to provide written informed consent
  • Age between 18 and 80 years
  • Weight 40 kg or more
  • English and non-English speaking patients eligible
  • Participants able to have children must use effective birth control during and up to 3 months post-study
  • Signed consent to long-term follow-up protocol
  • Disease-specific criteria for T-cell lymphomas, chronic lymphocytic leukemia, and mantle cell lymphoma as detailed
Not Eligible

You will not qualify if you...

  • Positive pregnancy test in females of child-bearing potential or lactating females
  • Clinically significant Grade 3 or higher toxicity from prior treatment
  • Uncontrolled infections not responding to therapy
  • Active hepatitis B or C infection
  • HIV with detectable viral load
  • Active neurological disorders
  • Active autoimmune disease within 12 months
  • Active brain or meningeal involvement by cancer
  • Active graft-versus-host disease requiring therapy
  • Other active malignancies except treated cervical intra-epithelial neoplasia and non-melanoma skin cancer
  • Serious medical conditions endangering patient per investigator
  • Major surgery within 4 weeks before first study drug dose
  • Allogeneic stem cell transplant or donor lymphocyte infusion within 12 weeks before first study drug dose
  • Concurrent use of other investigational or anti-cancer agents
  • Systemic steroids at time of NK cell infusion (except physiological doses) or recent T-cell targeting therapies
  • Use of immunosuppressive therapy
  • Diminished mental capacity preventing enrollment

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

C

Chitra Hosing

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

2

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