Phase II Study on NK Cell Therapy with or without DUK-CPG-001 for Patients After Stem Cell Transplant

Sponsor: Cristina Gasparetto

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT02452697

Provider View

This clinical trial is testing a new treatment using NK cell-enriched donor lymphocyte infusions, with or without an additional drug called DUK-CPG-001, to see if it can help patients who have had a stem cell transplant for blood cancers. The study aims to find out if this approach can improve survival without disease progression and assess any side effects.

Patient Parameters

Program Overview

The study is exploring whether NK cell-enriched donor lymphocyte infusions (DLIs), given alone or with a drug called DUK-CPG-001, can help patients who have undergone a type of stem cell transplant for blood cancers. The trial involves two groups: one with donors closely matched to the patient and another with less closely matched donors. The main goals are to see if this treatment can help patients live longer without their disease getting worse and to monitor any side effects.

Description

This study is testing a treatment involving NK cell-enriched donor lymphocyte infusions (DLIs) for patients who have had a stem cell transplant for blood cancers. The treatment is given either alone or with a drug called DUK-CPG-001. The study includes two groups based on how closely the donor's cells match the patient's cells. Patients will undergo various tests before starting the treatment, including blood tests and scans to assess their disease status. Donors will provide NK cells through a process called apheresis, and these cells will be processed and infused into the patient. The study will monitor the patient's disease status and immune function over time, with regular follow-ups to check for any side effects. Patients will also provide stool samples for microbiome analysis at different points during the study. The goal is to determine if this treatment can improve outcomes for patients after a stem cell transplant.

Eligibility Criteria

Inclusion Criteria

  • Patients with blood cancers who have had a specific type of stem cell transplant from a donor with a certain level of genetic match.
  • Must have a performance status score of 0, 1, or 2, indicating they are fully active or have some limitations but can still care for themselves.
  • Must have at least 2.5% donor cell engraftment from the transplant.
  • Must have less than grade 2 acute graft-versus-host disease (GVHD) at the time of the first NK cell infusion.
  • Must have an estimated survival of at least 8 weeks.
  • Must be 18 years or older.
  • Women of childbearing potential must have a negative pregnancy test before starting treatment and use contraception.
  • Men must agree to use birth control during the study and for 3 months after the infusion.

Exclusion Criteria

  • Pregnant or breastfeeding women.
  • Patients with major medical or psychiatric conditions that could affect their ability to tolerate the treatment.
  • Patients who are likely to have a better response to the transplant alone, such as those with certain genetic profiles or in early stages of their disease.
  • Donors must be a certain genetic match with the patient and able to provide informed consent.
  • Donors must not have medical conditions that make the apheresis process risky.
  • Female donors of childbearing potential must have a negative pregnancy test before donation.

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