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Cellular Therapies: Clinical Research Program

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Cellular Therapies: Clinical Studies Open For Enrollment

 

 

Allogeneic Stem Cell Transplant to Induce Mixed Donor Chimerism in Patients with Sickle Cell Disease & Thalassemia NYMC 556

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

Lauren_Harrison@nymc.edu

 

Cancer and Blood & Marrow Transplantation Wellness & Survivorship Research Registry

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

Lauren_Harrison@nymc.edu

 

Safety and Efficacy of Prophylactic Defibrotide Administration in Children, Adolescents and Young Adults with Sickle Cell Disease Following Myeloablative Conditioning (MAC) & Haploidentical Stem Cell Transplantation Utilizing CD34 Enrichment and T-Cell (CD3) Addback

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

Lauren_Harrison@nymc.edu

 

Pilot Study in the Treatment of Refractory Adenovirus (ADV) Infections with Related Donor ADV Specific Cytotoxic T-Cells (CTLs) in Children, Adolescents and Young Adult Recipients- NYMC 579

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

Lauren_Harrison@nymc.edu

 

A Pilot Study in the Treatment of Refractory Cytomegalovirus (CMV) Infections with Related Donor CMV Specific Cytotoxic T-Cells (CTLs) in Children, Adolescents and Young Adult Recipients- NYMC 580

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

Lauren_Harrison@nymc.edu

 

A Pilot Study in the Treatment of Refractory Epstein-Barr (EBV) Infections with Related Donor EBV Specific Cytotoxic T-Cells (CTLs) in Children, Adolescents and Young Adult Recipients- NYMC 581

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

Lauren_Harrison@nymc.edu

 

A phase II pilot trial to estimate survival after a non-total body irradiation (TBI) based conditioning regimen in patients diagnosed with B-acute lymphoblastic leukemia (ALL) who are pre-allogeneic hematopoietic cell transplantation (HCT) next-generation-sequence (NGS) minimal residual disease (MRD) negative

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

Lauren_Harrison@nymc.edu

 

Allogeneic Stem Cell Transplantation for Malignant and Non-malignant Hematologic Diseases Utilizing alpha/beta T cell and CD19+ B Cell Depletion: NYMC 588

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

Lauren_Harrison@nymc.edu

 

A Pilot Study in the Treatment of Refractory BK Infections with Related Donor BK Specific Cytotoxic T-cells (CTLs) in Children, Adolescents and Young Adult Recipients – NYMC 590

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

Lauren_Harrison@nymc.edu

 

A randomized trial of low versus moderate exposure busulfan for infants with severe combined immunodeficiency (SCID) receiving TCRαβ+/CD19+ depleted transplantation: A Phase II study by the Primary Immune Deficiency Treatment Consortium (PIDTC) and Pediatric Blood and Marrow Transplant Consortium (PBMTC)

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

Lauren_Harrison@nymc.edu

 

J12106 A Phase II Trial of Reduced Intensity Conditioning of Partially HLA-mismatched (HLA-haploidentical) Related Donor Bone Marrow Transplant for High-risk Solid Tumors

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

Lauren_Harrison@nymc.edu

 

ALXN1210-TMA-314 A Phase 3, Open-label, Single Arm, Multicenter Study of Ravulizumab in Addition to Best Supportive Care in Pediatric Participants (from 1 month to < 18 years of age) with Thrombotic Microangiopathy (TMA) after Hematopoietic Stem Cell Transplantation (HSCT)

Eligibility

  • Subject is no older than 17 years of age
  • Received Hematopoietic Stem Cell Transplant within the past 12 months
  • Diagnosis of Thrombotic Microangiopathy (TMA) that persists for at least 72 hours despite initial management

Enrollment Status: Enrolling

Study Information

ClinicalTrials.gov | NCT04557735

Principal Investigator

Mitchell Cairo, MD

Contact for Study Screening

Lauren_Harrison@nymc.edu

 

ALXN1210-TMA-313 A PHASE 3, OPEN-LABEL, RANDOMIZED, MULTICENTER STUDY OF RAVULIZUMAB IN ADULT AND ADOLESCENT PARTICIPANTS WHO HAVE THROMBOTIC MICROANGIOPATHY (TMA) AFTER HEMATOPOIETIC STEM CELL TRANSPLANT (HSCT)

Eligibility

  • Subject is at least 12 years of age
  • Received HSCT within the past 12 months
  • Diagnosis of TMA that persists for at least 72 hours despite initial management

Enrollment Status: Enrolling

Study Information

ClinicalTrials.gov | NCT04543591

Principal Investigator

Mitchell Cairo, MD

Contact for Study Screening

Lauren_Harrison@nymc.edu

 

A Phase II Pilot Study of Donor-Derived Ex-Vivo Expanded Natural Killer Cell Infusions in Children and Young Adults with High Risk Acute Myeloid Leukemia Receiving Myeloablative HLA-Haploidentical Hematopoietic Cell Transplant: A Multicenter Pediatric Transplantation and Cellular Therapy Consortium (PTCTC) Study (EXCEL Trial)

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

Lauren_Harrison@nymc.edu

 

A Pilot Study of SARS-CoV-2 Specific Cytotoxic T Lymphocytes (SARS-CoV-2-CTLs) for Treatment of Mild to Moderate Coronavirus Disease 2019 (COVID-19)

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

Lauren_Harrison@nymc.edu

 

A PHASE I MULTI-DOSE STUDY OF HUMAN PLACENTAL HEMATOPOIETIC STEM CELL DERIVED NATURAL KILLER CELLS (CYNK-001) WITH OR WITHOUT RECOMBINANT HUMAN INTERLEUKIN-2 (RHIL-2) IN ADULTS WITH PRIMARY OR SECONDARY ACUTE MYELOID LEUKEMIA (AML) IN MORPHOLOGIC COMPLETE REMISSION WITH MINIMAL RESIDUAL DISEASE (MRD) OR RELAPSED/REFRACTORY AML

Eligibility

  • Subject is at least 18 years of age
  • Primary or Secondary acute myeloid leukemia (AML)
  • Patients in first of second Morphological Complete Remission (CR), Morphological Complete Remission with incomplete hematologic recovery (CRi), or Morphologic Leukemia-free State (MLFS)
  • Relapsed AML are defined as having relapsed after achieving at least 1 CR, including relapse after allogeneic stem cell transplantation (at least two months after transplant)
  • Refractory AML, defined as not achieving CR, CRi, or MLFS after two or more cycles of induction therapy (primary refractory) or not achieving CR after treatment for relapsed AML
  • Secondary AML (MDS transformation): Secondary AML patients are eligible to participate if they have received a minimum of one prior line of treatment for AML
  • Treatment-related AML: Treatment-related AML patients are eligible to participate if they have received a minimum of one prior line of treatment for AML

Enrollment Status: Enrolling

Study Information

ClinicalTrials.gov | NCT04310592

Principal Investigator

Mitchell Cairo, MD

Contact for Study Screening

Lauren_Harrison@nymc.edu