Study on Using TCRγδ T Cells and Memory T Cells with Blinatumomab for Blood Cancer Patients After Previous Transplant

Sponsor: St. Jude Children's Research Hospital

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT02790515

Provider View

This clinical trial is exploring a new treatment approach for patients with blood cancers that have returned or not responded to previous transplants. The study aims to improve immune recovery, reduce side effects, and enhance survival rates by using a special type of cell transplant and the drug Blinatumomab.

Patient Parameters

Program Overview

The study is testing a new treatment method to help patients with blood cancers that have come back or not responded after a previous transplant. The goal is to improve the immune system's recovery, reduce the risk of relapse, and improve survival without severe side effects. The treatment involves using a special type of cell transplant from a partially matched family donor, along with a drug called Blinatumomab, to help fight the cancer.

Description

In this study, patients will receive blood-forming cells from a partially matched family member. These cells are specially processed to reduce the risk of complications. Before the transplant, patients will undergo a conditioning treatment with several medications to prepare their body. This includes drugs like rabbit ATG, cyclophosphamide, fludarabine, thiotepa, melphalan, and rituximab. Mesna is used to prevent side effects from cyclophosphamide, and tacrolimus is given to reduce the risk of graft-versus-host disease (GVHD). After the transplant, G-CSF is administered to help the new cells grow and strengthen the immune system.

The transplant involves two infusions of blood-forming cells on consecutive days. These cells travel to the bone marrow, where they are expected to grow and help the body produce new blood cells. Patients will be closely monitored for 100 days to ensure the new cells are growing properly. If needed, additional cells may be given.

Blood tests will continue for up to a year to check how well the donor cells are growing and their impact on the immune system's ability to fight infections.

Eligibility Criteria

Inclusion Criteria for Transplant Recipient:

  • Age less than or equal to 21 years.

  • Any of the following hematologic malignancies that has relapsed or remains refractory after prior allogeneic HCT (this includes any stage of disease - such as refractory due to induction failure, refractory in relapse, or in any CR - as long as the hematologic malignancy remained persistent or returned after a previous allogeneic HCT):

    • ALL, AML, Myeloid Sarcoma, CML, Juvenile myelomonocytic leukemia (JMML), myelodysplastic syndrome (MDS), non-Hodgkin lymphoma (NHL)

  • Has a suitable single haplotype matched (≥ 3 of 6) family member donor.

  • Does not have any other active malignancy other than the one for which this transplant is indicated.

  • If prior CNS leukemia, it must be treated and in CNS CR

  • Does not have current uncontrolled bacterial, fungal, or viral infection.

  • There is no minimum time from the previous transplant, but patients must meet the following criteria:

    • Left ventricular ejection fraction > 40%, or shortening fraction ≥ 25%.
    • Creatinine clearance (CrCl) or glomerular filtration rate (GFR) ≥ 50 ml/min/1.73m2.
    • Forced vital capacity (FVC) ≥ 40% of predicted value; or pulse oximetry ≥ 92% on room air if patient is unable to perform pulmonary function testing.
    • Karnofsky or Lansky (age-dependent) performance score ≥ 50 (See Appendix A).
    • Bilirubin ≤ 3 times the upper limit of normal for age.
    • Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤ 5 times the upper limit of normal for age.
    • Not pregnant. If female with child bearing potential, must be confirmed by negative serum or urine pregnancy test within 14 days prior to enrollment.
    • Not breast feeding

Inclusion Criteria for Haploidentical Donor:

  • At least single haplotype matched (≥ 3 of 6) family member

  • At least 18 years of age.

  • HIV negative.

  • Not pregnant as confirmed by negative serum or urine pregnancy test within 14 days prior to enrollment (if female).

  • Not breast feeding.

  • Regarding donation eligibility, is identified as either:

    • Completed the process of donor eligibility determination as outlined in 21 CFR 1271 and agency guidance; OR
    • Does not meet 21 CFR 1271 eligibility requirements, but has a declaration of urgent medical need completed by the principal investigator or physician sub-investigator per 21 CFR 1271.

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