Trial Search Results

Phase I/II MAHCT w/ TCell Depleted Graft w/ Simultaneous Infusion Conventional and Regulatory T Cell

For patients with hematologic malignancies undergoing allogeneic myeloablative (MA) HCT with a T cell depleted graft, the infusion of naturally occurring regulatory T cells with conventional T cells (T cell addback) in pre-defined doses and ratios will reduce the incidence of acute graft vs host disease while augmenting the graft vs leukemia effect and improving immune reconstitution.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Everett Meyer

Collaborator: National Institutes of Health (NIH)


  • Biological: Conventional T cells (Tcon) and Regulatory T cells (Treg)


Phase 1/Phase 2


Recipient Inclusion Criteria

   1. Patients with the following diseases that are histopathologically confirmed are

      - Acute leukemia, primary refractory or beyond CR1, or minimal residual disease
      (MRD) positivity.

      - High risk acute myeloid leukemia in CR1 with any of the following features:

      - Complex karyotype(≥3 clonal chromosomal abnormalities)

      - Any of the following high risk chromosomal abnormalities:

         - Monosomal karyotype (-5, 5q-, -7, 7q-)

         - t(11q23), t(9;11), inv(3), t(3;3) t(6;9) t(9;22)

         - Normal karyotype with FLT3-ITD mutation

      - Chronic myelogenous leukemia (accelerated, blast or second chronic phase)

      - Myelodysplastic syndromes

      - Myeloproliferative syndromes

      - Non-Hodgkin lymphoma with poor risk features not suitable for autologous HCT

   2. Age ≥18 yo and ≤ 60 yo for patients in Cohort 1 only. At the start of Cohort 2A and
   beyond, eligibility will be expanded to allow pediatric patients age ≥ 13 yo.

   3. Cardiac ejection fraction ≥ 45%

   4. Lung diffusion capacity ≥ 50%

   5. Calculated creatinine clearance ≥ 50 cc/min

   6. SGPT and SGOT ≤ 2.5 x ULN, unless elevated secondary to disease. Total bilirubin ≤ 2 x
   ULN (patients with Gilbert's syndrome may be included at the discretion of the PI or
   where hemolysis has been excluded

   7. Availability of an 6/6 HLA matched sibling defined by Class I (HLA -A and B) serologic
   typing (or higher resolution) and Class II (HLA-DRB1) molecular typing.

   8. Karnofsky performance status ≥70%

   9. No prior myeloablative therapy or hematopoietic cell transplantation

Recipient Exclusion Criteria

   1. Seropositive for any of the following: HIV ab, hepatitis B sAg , hepatitis C IgG Ab
   positive, without definitive therapy for hepatitis C; or hepatitis C PCR positivity;
   or hepatitis C IgM positivity

   2. Uncontrolled bacterial, viral or fungal infection defined as currently taking
   antimicrobial therapy and progression of clinical symptoms.

   3. Uncontrolled CNS disease involvement

   4. The recipient is pregnant or a lactating female.

   5. Psychosocial circumstances that preclude the patient being able to go through
   transplant or participate responsibly in follow up care

Donor Inclusion Criteria

   1. Age ≥13 yo and ≤ 75 years

   2. Karnofsky performance status of ≥ 70% defined by institutional standards

   3. Seronegative for HIV 1 RNA PCR; HIV 1 and HIV 2 ab (antibody); HTLV 1 and HTLV 2 ab;
   PCR+ or sAg (surface antigen) hepatitis B ; or PCR+ or sAg for hepatitis C; negative
   for the Treponema palladum antibody Syphillis screen; and negative for HIV 1 and
   hepatitis C by nucleic acid testing (NAT) within 30 days of apheresis collection. In
   the case that T palladum antibody tests are positive, donors must:

      - Be evaluated and show no evidence of syphilis infection of any stage by physical
      exam and history

      - Have completed effective antibiotic therapy to treat syphilis

      - Have a documented negative non treponemal test (such as RPR) or in the case of a
      positive non treponemal test must be evaluated by an infectious disease expert to
      evaluate for alternative causes of test positivity and confirm no evidence of
      active syphilitic disease

   4. Must be 6/6 matched sibling donor as determined by HLA typing

   5. Female donors of child-bearing potential must have a negative serum or urine beta-HCG
   test within three weeks of mobilization

   6. Capable of undergoing leukapheresis, have adequate venous access, and be willing to
   undergo insertion of a central catheter should leukapheresis via peripheral vein be

   7. The donor or legal guardian greater than 18 years of age, capable of signing an
   IRB-approved consent form.

Donor Exclusion Criteria

   1. Evidence of active infection or viral hepatitis

   2. HIV positive

   3. Lactating female

Ages Eligible for Study

13 Years - 60 Years

Genders Eligible for Study


Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Physician Referrals
Not Recruiting