Phase I/II Study of Treg/Tcon Addback to Partially Matched Related Donor Stem Cells With Myeloablative Conditioning and Post-transplant Cyclophosphamide for High Risk Hematologic Malignancies

Inclusion Criteria:

1. Age 0-70 years 2. Karnofsky or Lansky Performance status >70% 3. High risk hematologic
malignancy 4. Acute myeloid leukemia (AML) with one or more of the following criteria:
4a.Poor risk cytogenetics, including -5, 5q-, -7, 7q-, t(9;22); complex cytogenetics (>3
abnormalities); or normal cytogenetics with Flt3 ITD, in first or subsequent complete
remission (CR).

4b. Relapsed or primary refractory AML with <10% blasts in the peripheral blood.

4c. Subjects in CR1 who required two cycles of induction to achieve remission may be
included at the discretion of the treating physician.

4d. Standard risk or intermediate risk cytogenetics in second or subsequent CR (enrolled at
the discretion of the treating physician).

5. Acute lymphoblastic leukemia (ALL) with one of the following criteria: 5a. Second or
subsequent CR 5b. Any PR (no circulating blasts) 5c. High-risk ALL in first CR including
(Ph+, t(4:11), complex karyotype, hypodiploidy (<44 chromosomes), or positive MRD after
induction 6. Myelodysplasia, intermediate -2 (score 1.5-2.0) or high risk (score >2.5) by
the International Prognostic Score System.

7. Myeloproliferative Disorders (include CMML, AMM or Idiopathic Myelofibrosis, and JMML)
with excess blasts (>5%) 8. Chronic myeloid leukemia (CML) with one of the following
criteria: 8a. Second or subsequent chronic phase 8b. Accelerated phase 8c. blast crisis 9.
Non-Hodgkin's lymphoma (NHL) meeting one of the following criteria: 9a. Relapse after
autologous stem cell transplantation with evidence of responsive disease.

9b. Subject with chemosensitive relapse who have no option for autologous stem cell
transplantation due to blood or marrow involvement or failure to mobilize autologous stem
cells or are not considered eligible for autologous transplant by their treating physician.

9c. Hodgkin's Lymphoma: relapse after autologous HCT, chemo-refractory disease 9d. Multiple
myeloma: per NCCN guidelines. Updated annually at: www.nccn.org 10. No suitable
HLA-identical sibling donor. 11. No identified 8/8 (based upon A, B, C, DRB1 loci) allele
matched unrelated donor, or unable to wait sufficient time to procure a 8/8 allele matched
unrelated donor 12. Available HLA 3-5/6 matched genotypically haploidentical partially
matched related donor 13. Female subjects must be surgically sterile, postmenopausal
(minimum 1 year without menses), or agree to use approved form of contraception from the
time of signing the informed consent form through Day +100. Male subjects must also agree
to use an approved form of birth control for either themselves or their partner, as
appropriate, from the time of signing the informed consent form through Day +100.

14. Able to provide informed consent and have signed an approved consent form that conforms
to federal and institutional guidelines.

Exclusion Criteria:

1. Available HLA identical matched sibling donor (unless having failed a prior allogeneic
transplant from an HLA identical matched sibling)

2. Recipient HLA antibodies against donor HLA

3. Any of the following organ dysfunctions:

1. Cardiac- left ventricular ejection fraction <40%, symptomatic coronary artery
disease, or uncontrolled arrhythmias

2. Pulmonary- FEV1 or DLco<40% or need for use of supplemental oxygen

3. Renal- calculated or measured GFR <30 ml/min, dialysis requirement, or prior
renal transplant

4. Hepatic- bilirubin > 2.0, ALT> 2.5 X ULN, cirrhosis

4. Subjects with active or uncontrolled bacterial, viral, or fungal infections requiring
systemic therapy.

5. Subjects who have tested positive for HIV.

6. Pregnant women, nursing mothers or women of child-bearing potential who are unwilling
to use medically accepted methods of contraception.