Obstetrics & Gynecology Research & Clinical Trials | NYU Langone Health
NYU Langone Obstetrics & Gynecology Associates offers opportunities to participate in clinical trials and research studies.
Obstetrics Doctors | NYU Langone Health
View all NYU Langone doctors who specialize in obstetrics.
Obstructive Sleep Apnea | NYU Langone Health
NYU Langone doctors offer expert evaluation and management of obstructive sleep apnea and snoring.
Occupational Therapy | NYU Langone Health
Occupational therapists at NYU Langone’s Rusk Rehabilitation help adults reclaim their independence by helping them master everyday skills.
Occupational Therapy for Children | NYU Langone Health
At Hassenfeld Children’s Hospital at NYU Langone, occupational therapists from Rusk Rehabilitation help children with daily life activities.
Occupational Therapy for Hand Sprains & Strains | NYU Langone Health
Occupational therapists at NYU Langone help you rebuild strength and flexibility after a hand sprain or strain.
Oculoplastic Surgery | NYU Langone Health
NYU Langone oculoplastic surgeons offer evaluations and treatment for conditions affecting the eye.
Oculoplastic Surgery Doctors | NYU Langone Health
Find a doctor at the Oculoplastic Surgery at NYU Langone.
Older Adult Services at Family Health Centers at NYU Langone | NYU Langone Health
Older adult services are provided through Family Health Centers at NYU Langone’s Community-Based Programs.
Open-Label Multicenter Phase 1 Study to Assess the Safety of P-CD19CD20-ALLO1 in Subjects with Selected Relapsed/Refractory B cell Malignancies
This Phase 1, multi-center, open-label, dose escalation study will enroll and treat approximately 120 adult subjects with relapsed/refractory DLBCL NOS (including DLBCL arising from indolent lymphomas), HGBL, PMBCL, and tFL or follicular lymphoma Grade 3B.This study consists of 2 parts: dose escalation (Part 1) and expansion at a selected dose (= MTD or RDE) and LD regimen (Part 2).Only sites that are experienced in managing oncology subjects and stem-cell/bone marrow transplant and have the resources to manage the types of acute emergent events expected with CAR-T cell administration will be selected to participate in this study. A Safety Committee will meet regularly to review safety data throughout the study.Part 1 (Dose Escalation)During Part 1, dose levels shown in Table 1 will be evaluated using a 3+3 escalation design.Subjects and cohorts will be staggered as follows:• The dosing of the first 3 subjects in all cohorts in Arm S will be staggered by a minimum of 28 days.• There will be a minimum 28-day stagger period between dose escalation cohorts in Arm S.• Dosing in Arms LD 750 and LD 1000 will be = the maximum cleared P-CD19CD20-ALLO1 dose level in Arm S and may enroll concurrently.• The first 2 subjects in Arms LD 750 and LD 1000 at each P-CD19CD20-ALLO1 dose level will be staggered by a minimum of 14 days.The Safety Committee will review the data for each dose cohort to determine progression to the next dose cohort. The Safety Committee may recommend enrollment of additional subjects in a dose cohort of an Arm to further evaluate the outcomes observed at that dose level.The first 3 subjects in each cohort in Arm S must be admitted to the hospital for P-CD19CD20-ALLO1 administration for 7 days. Subjects should remain within 2 hours driving distance from the hospital through 28 days after administration of P-CD19CD20-ALLO1 to attend clinic visits.Dose Escalation GuidelinesThe 3+3 dose escalation will be conducted per Table 2, with the Safety Committee reviewing the data from each dose cohort to determine the outcome. Beginning with Cohort 1 of Arm S (LD regimen of cyclophosphamide (500 mg/m2) and fludarabine (30 mg/m2) and P-CD19CD20-ALLO1 dose of 0.75 × 106 cells/kg), at least 3 subjects will be dosed in the cohort. If no DLT through Day 28 is observed in the first 3 subjects, then dose escalation may proceed to Cohort 2 of Arm S (LD regimen of cyclophosphamide (500 mg/m2) and fludarabine (30 mg/m2) and P-CD19CD20-ALLO1 dose of 2 × 106 cells/kg). Concurrently, Arm LD 750 and Arm LD 1000 may begin enrolling at the cleared Cohort 1 P-CD19CD20-ALLO1 dose of 0.75 × 106 cells/kg.If a DLT is observed in 1 of the first 3 subjects in any Cohort of Arm S, then at least 3 additional subjects will be treated at this dose level. If no further DLT is observed, dose escalation may proceed. If DLTs are observed in 2 or more of 6 subjects, the MTD will be considered to be at the next lower dose level and further enrollment may take place at a lower dose level, or an intermediate dose level may be tested at the discretion of the Safety Committee. If 2 or more subjects experience DLTs in Cohort 1, the Safety Committee, after reviewing available data, may elect to dose 3 subjects in either Cohort minus 1 or Cohort minus 2 with the same 3+3 expansion rules. If 2 or more subjects experience DLTs in Cohort minus 1, the Safety Committee, based on the consideration of safety and efficacy data to assess risk vs. benefit, may elect to dose 3 subjects at a lower dose (Cohort minus 2) with the same 3+3 expansion rules or recommend study discontinuation.If a DLT is observed in 1 of the first 3 subjects in any Cohort of Arm LD 750 or Arm LD 1000, then at least 3 additional subjects will be treated at this dose level and LD regimen. If no further DLT is observed, dose escalation may proceed as P-CD19CD20-ALLO1 dose levels are cleared in Arm S. If DLTs are observed in 2 or more of 6 subjects, the MTD will be considered to be at the next lower P-CD19CD20-ALLO1 dose level and further enrollment may take place at a lower dose level, or an intermediate dose level may be tested at the discretion of the Safety Committee. If 2 or more subjects experience DLTs in Cohort 1, the Safety Committee, after reviewing available data, may elect to dose 3 subjects in either Cohort minus 1 or Cohort minus 2 with the same 3+3 expansion rules. If 2 or more subjects experience DLTs in Cohort minus 1, the Safety Committee, based on the consideration of safety and efficacy data to assess risk vs. benefit, may elect to dose 3 subjects at a lower dose (Cohort minus 2) with the same 3+3 expansion rules or recommend discontinuation of the study Arm.If Cohort 5 is completed in any Arm without identifying an MTD, the Safety Committee may elect to select recommended dose(s) for expansion (RDE) based on established safe doses in Part 1. The Safety Committee may also assess further dose escalation cohorts in increments of 5 to 10 × 106 P-CD19CD20-ALLO1 cells/kg beyond the Cohort 5 dose level. Dose escalation beyond Cohort 5 will proceed only following protocol amendment.Part 2 (Expansion)In Part 2, safety and efficacy data will be monitored at regular intervals throughout the study by the Sponsor medical monitor and Safety Committee to ensure subjects safety.Part 2 will include a population of subjects with B cell malignancies selected based on results from Part 1 and may include one or more of the histologic subtypes of Part 1. Criteria for tumor selection will be based on safety and emerging efficacy observed in Part 1.Subjects in Part 2 will receive P-CD19CD20-ALLO1 at selected dose(s) and LD chemotherapy regimen(s) from Part 1 that were deemed safe based on the safety data, and available PK data, as well as available response data, as determined by the Sponsor. Up to 2 dose levels may be identified from Part 1 for the Part 2 dose expansion. A dose level where no more than 1 of 6 subjects experienced DLTs in Part 1 may continue evaluation with additional subject enrollment for Part 2 if the review of safety, PK, and available response data warrants its expansion. This additional subject enrollment may proceed, while other subjects are undergoing the DLT evaluation period at higher dose levels in Part 1.The Safety Committee and the Sponsor will review all available safety, PK, and/or response data to evaluate the dose(s) in the expansion cohort for selection of the recommended Phase 2 dose (RP2D). An additional 10 subjects may be enrolled at the selected RP2D. In addition, based on discussion with the Safety Committee, other B cell malignancies, such as indolent lymphomas or chronic lymphocytic leukemia (CLL), may also be considered to be evaluated in a separate cohort at documented safe dose(s) from Part 1; up to 20 subjects may be enrolled.