Cellular Therapies: Clinical Research Program

Eligibility

• Subject is 30 years of age or younger
• Diagnosis of Homozygous Hemoglobin S Disease or Heterozygous Hemoglobin Sickle Cell (SC) or S 0/+ thalassemia, or Sickle/variant resulting in Chronic Hemolytic Anemia with hemoglobin (HgB) ≤10 mg/dL

Enrollment Status: Enrolling

Study Information

ClinicalTrials.gov | NCT00408447

Principal Investigator

Mitchell S. Cairo, MD

Contact for Study Screening

[email protected]

Eligibility

• Subject is one year old or older
• Malignant tumor diagnosed and/or treated at Westchester Medical Center and/or Maria Fareri Children’s Hospital
• Blood and marrow transplantation recipients transplanted at Westchester Medical Center and/or Maria Fareri Children’s Hospital
• More than one year from diagnosis and/or last treatment

Enrollment Status: Enrolling

Principal Investigator

Jessica Hochberg, MD

Contact for Study Screening

[email protected]

Eligibility

• Subject is between six months and 35 years of age
• Homozygous Hemoglobin S Disease, or Hemoglobin S B0/+ thalassemia, or Hemoglobin SC Disease, or Beta thalassemia intermedia/majora

Enrollment Status: Enrolling

Study Information

ClinicalTrials.gov | NCT02675959

Principal Investigator

Mitchell S. Cairo, MD

Contact for Study Screening

[email protected]

Eligibility

• Subject is 30 years of age or younger
• Adenovirus infections post allogeneic HSCT, with primary immunodeficiencies or post solid organ transplant with:
  • Increasing or persistent quantitative ADV RT-PCR DNA copies despite two weeks of appropriate anti-viral therapy and/or
  • Clinical symptoms attributed to adenovirus, including pneumonitis, hemorrhagic cystitis, colitis, hepatitis and/or
  • Medical intolerance to anti-viral therapies including:
    • Grade 2 renal insufficiency secondary to cidofovir
    • Related donor available with a T-cell response to the viral MACS® GMP PepTivator antigen(s) of adenovirus.
    • Third Party Related Allogeneic Donor: If original donor is not available or does not have a T-cell response: third party allogeneic donor (family donor > 3 HLA A, B, DR match to recipient) with a T-cell response at least to the viral MACS® GMP PepTivator antigen(s) of adenovirus.

Enrollment Status: Enrolling

Study Information

ClinicalTrials.gov | NCT03266627

Principal Investigator

Mitchell S. Cairo, MD

Contact for Study Screening

[email protected]

Eligibility

• Subject is 30 years of age or younger
• Refractory CMV infection post allogeneic HSCT, with primary immunodeficiencies or post solid organ transplant with either:
  • Increasing or persistent quantitative qRT-PCR DNA copies despite two weeks of appropriate anti-viral therapy and/or
  • Medical intolerance to anti-viral therapies including:
    • ANC less than 500/mm2 secondary to ganciclovir
    • 2 renal toxicity with foscarnet and/or
    • Known resistance to ganciclovir and/or foscarnet; Related donor available with a T-cell response to the CMV MACS® GMP PepTivator antigen(s)
    • Third Party Allogeneic Donor: If original donor is not available or does not have a T-cell response: third party related allogeneic donor (family donor > 3 HLA A, B, DR match to recipient) with IgG positive to CMV and/or a T-cell response to the CMV MACS® GMP PepTivator.

Enrollment Status: Enrolling

Study Information

ClinicalTrials.gov | NCT03266640

Principal Investigator

Mitchell S. Cairo, MD

Contact for Study Screening

[email protected]

Eligibility

• Subject is 30 years of age or younger
• Epstein-Barr virus infections post allogeneic HSCT, primary immunodeficiencies or post solid organ transplant with:
  • Increasing or persistent quantitative EBV RT-PCR DNA copies despite two weeks of appropriate anti-viral therapy and/or
  • Progressive clinical symptoms attributable to EBV, including biopsy proven colitis, lymphadenopathy, hepatomegaly, splenomegaly and/or
  • Medical intolerance to anti-viral therapies
  • Related donor available with a T-cell response to the EBV MACS® GMP PepTivator antigen(s) causing the therapy-refractory EBV infection
  • Third Party Related Allogeneic Donor: If original donor is not available or does not have a T-cell response: third party related allogeneic donor (family donor > 3 HLA A, B, DR match to recipient) with IgG positive to EBV and/or a T-cell response at least to the viral MACS® GMP PepTivator EBV Select (containing among other antigens, NA-1, LMP2A and BZLF-1).

Enrollment Status: Enrolling

Study Information

ClinicalTrials.gov | NCT03266653

Principal Investigator

Mitchell S. Cairo, MD

Contact for Study Screening

[email protected]

Eligibility

• Subject is between one year and 25 years of age
• Disease status: B-ALL in first (CR1) or second remission (CR2)
• No prior allogeneic hematopoietic stem cell transplant.
• Patients in CR1 or CR2 after blinatumomab treatment
• Patients in CR1 or CR2 after CAR-T cellular therapy

Enrollment Status: Enrolling

Study Information

ClinicalTrials.gov | NCT03509961

Principal Investigator

Jordan Brittni Milner, MD

Contact for Study Screening

[email protected]

Eligibility

• Subject is less than 30 years of age
• High-risk ALL in first remission, ALL in second remission or greater
• AML induction failure, AML with MRD or poor cytogenetics, AML in CR2 or greater; JMML
• Bone Marrow Failure syndromes
• Sickle Cell Disease, Beta-Thalassemia, Solid Tumors

Enrollment Status: Enrolling

Study Information

ClinicalTrials.gov | NCT04099966

Principal Investigator

Jordan Brittni Milner, MD

Contact for Study Screening

[email protected]

Eligibility

• Subject is between one month and 30 years of age
• Patients with refractory BK infection post allogeneic HSCT, post solid organ transplantation or with primary immunodeficiencies with either increasing urine and/or plasma BK RT-PCR DNA (by 1 log) after 7 days or persistent quantitative qRT-PCR DNA copies after 14 days despite two weeks of appropriate anti-viral therapy and/or
• Medical intolerance to anti-viral therapies including 2 renal toxicity with cidofovir or other greater than grade 2 toxicities secondary to cidofovir and/or known resistance to cidofovir

Enrollment Status: Enrolling

Study Information

ClinicalTrials.gov | NCT04197596

Principal Investigator

Mitchell Cairo, MD

Contact for Study Screening

[email protected]

Eligibility

• Subject is no more than two years of age
• Infants with SCID, either typical or leaky or Omenn syndrome

Enrollment Status: Enrolling

Study Information

ClinicalTrials.gov | NCT03619551

Principal Investigator

Jordan Brittni Milner, MD

Contact for Study Screening

[email protected]

Eligibility

• Subject is between one and 50 years of age
• Neuroblastoma or ganglioneuroblastoma either: Failure to achieve at least a PR after induction therapy with COG ANBL0532 or standard chemotherapy
• Refractory to induction chemotherapy with COG ANBL0532 or standard chemotherapy, or
• Patients with high risk disease
• Metastatic Ewing Sarcoma
• Osteosarcoma with metastatic disease beyond the lungs and/or with lung metastases not amenable to resection
• Desmoplastic small round cell tumor

Enrollment Status: Enrolling

Study Information

ClinicalTrials.gov | NCT01804634

Principal Investigator

Aliza Gardenswartz, MD

Contact for Study Screening

[email protected]

Eligibility

• Subject is no older than 25 years of age
• High-risk AML, as defined by one of the following:
  • AML in CR1 (defined as less than 5% blasts in BM by morphology and flow cytometry) having at least one of these high-risk features:
    • Mutations associated with high risk disease (Appendix A) Other high-risk features not explicitly stated in Appendix A can be considered after discussion/approval with the protocol chair/team
    • MRD-positive at the end of Induction I chemotherapy (defined as flow cytometry at least 0.1% blasts)
  • AML in at least CR2 (defined by less than 5% blasts in BM by morphology and flow cytometry)

Enrollment Status: Enrolling

Study Information

ClinicalTrials.gov | NCT04836390

Principal Investigator

Aliza Gardenswartz, MD

Contact for Study Screening

[email protected]

Eligibility

• Subject is between 18 – 65 years of age
• Proven infection with SARS-CoV-2, and
• Hospitalized at the time of enrollment, and
• HLA Matched Family Related donor with recent SARS-CoV-2 infection is at least 10 days out from symptom onset, and
• In Stage I or II of disease (mild or moderate) at the time of enrollment, and
• One of the following high-risk conditions:
  • Chronic lung disease not requiring oxygen at home prior to admission (including but not limited to COPD, cystic fibrosis, asthma and sickle cell disease)
  • Underlying heart disease (including hypertension)
  • Patients with an acute myocardial infarction within the last three months will require cardiology clearance prior to enrollment
  • Diabetes mellitus (type I or II)
  • Obesity (BMI at least 30)
  • Immunosuppressed

Enrollment Status: Enrolling

Study Information

ClinicalTrials.gov | NCT04896606

Principal Investigator

Mitchell Cairo, MD

Contact for Study Screening

[email protected]

Eligibility

• Subject is between 28 days and 17 years of age
• Evidence of high-risk haematopoietic stem cell thrombotic microangiopathy

Enrollment Status: Enrolling

Study Information

ClinicalTrials.gov | NCT05855083

Principal Investigator

Mitchell Cairo, MD

Contact for Study Screening

[email protected]