Administration of Donor T Cells With the Caspase-9 Suicide Gene

Plain-language summary

This study examines infusing donor T cells engineered with a caspase-9 suicide gene in patients who lack a suitable conventional donor or whose disease is progressing rapidly. If the cells cause graft-versus-host disease, they can be eliminated with the drug AP1903. It is a Phase 1 study, active but not currently recruiting.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

Phase 1

Status

Active, not recruiting

Sponsor

Baylor College of Medicine

Intervention

iCaspase9-transduced T cells, AP1903

Start date

11/1/2011

Estimated completion

5/1/2029

Countries

United States

Related genes

Locations

• Houston, United States
• Houston, United States

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

Inclusion Criteria:

Inclusion Criteria at Time of Procurement:

1. Lack of a suitable conventional donor (i.e. 5/6 or 6/6 related, or 5/6 or 6/6 unrelated donor), or presence of a rapidly progressive disease not permitting time to identify an unrelated donor.
2. High risk disease in one of the following:

   * Myelodysplastic syndrome (MDS) in one of the following categories: RCMD with an IPSS-R of intermediate, poor, or very poor, RAEB-1, or RAEB-2
   * Acute myeloid leukemia (AML) after first relapse or primary refractory disease
   * Chronic myelogenous leukemia (CML) in Chronic Phase 2 or greater, Accelerated Phase or Blast Crisis
   * Acute lymphoblastic leukemia (ALL) after first relapse or primary refractory disease, or High-Grade Non Hodgkin lymphoma (NHL) Stage III or IV after first relapse or primary refractory disease
   * Hemophagocytic lymphohistiocytosis (HLH)
   * Familial hemophagocytic lymphohistiocytosis (FLH)
   * Viral-associated hemophagocytic syndrome (VAHS)
   * T or NK cell lymphoproliferative syndrome
   * X-linked lymphoproliferative disease (XLP)

Inclusion Criteria at Time of T Cell Infusion:

1. Engrafted with an absolute neutrophil count (ANC) \> 500 cells/µL
2. Greater than or equal to 50% donor chimerism in either peripheral blood or bone marrow, or relapse of their original disease
3. Life expectancy \> 30 days
4. Lansky/Karnofsky score greater than or equal to 60
5. Absence of severe renal disease (creatinine \> 2X upper limit of normal for age)
6. Absence of severe hepatic disease (direct bilirubin \> 3X upper limit of normal or SGOT \> 3X upper limit of normal)
7. Oxygen saturation \> 94% on room air
8. Patient/Guardian able to give informed consent
9. AP1903 available in sufficient quantities to allow for treatment of the patient

Exclusion Criteria:

Exclusion Criteria at Time of T Cell Infusion:

1. GvHD
2. Severe intercurrent infection
3. Pregnancy\*
4. Other investigational drugs in the prior 30 days

   * Pregnancy test only required for at-risk individuals, defined as female patients of childbearing potential who have received a reduced-intensity conditioning regimen.