A Phase 1 Trial of CD33xCD3 BsAb in Pediatric Patients With Relapsed or Refractory Acute Myeloid Leukemia
NCT05077423 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 3
Last updated 2023-05-30
Summary
Pediatric patients (\<21 years at study entry) with relapsed or refractory acute myeloid leukemia (AML) will be treated with CD33\*CD3 a bispecific antibody to investigate the safety and tolerability of the drug.
Conditions
- AML, Childhood
Interventions
- DRUG
-
CD33*CD3 BsAb
CD33xCD3 is a bispecific monoclonal antibody, which specifically targets CD33 on the AML blasts and CD3 on the T cells
Sponsors & Collaborators
-
Children's Oncology Group
collaborator NETWORK -
Y-mAbs Therapeutics
lead INDUSTRY
Principal Investigators
-
Jessica Pollard, MD · Dana-Farber Cancer Institute
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 2 Years
- Max Age
- 21 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-05-25
- Primary Completion
- 2022-12-01
- Completion
- 2022-12-01
- FDA Drug
- Yes
Countries
- United States
Study Locations
More Related Trials
-
A Phase 1/2 Study of Bleximenib in Participants With Acute Leukemia (cAMeLot-1)
NCT04811560 ·Status: RECRUITING ·Phase: PHASE1/PHASE2
-
AC220 for Children With Relapsed/Refractory ALL or AML
NCT01411267 ·Status: COMPLETED ·Phase: PHASE1
-
Safety Study of CPX-351 in Children With Relapsed Leukemia or Lymphoma
NCT01943682 ·Status: COMPLETED ·Phase: PHASE1
-
A Study of TAS1553 in Subjects With Relapsed or Refractory Acute Myeloid Leukemia (AML) and Other Myeloid Neoplasms
NCT04637009 ·Status: TERMINATED ·Phase: PHASE1
-
Immunotoxin Therapy and Cytarabine in Treating Patients With Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia
NCT01408160 ·Status: TERMINATED ·Phase: PHASE1
-
PH 1 Study to Evaluate Safety and Tolerability of XmAb14045 in Patients With CD123-expressing Hematologic Malignancies
NCT02730312 ·Status: COMPLETED ·Phase: PHASE1
-
A Study of ASTX660 as a Single Agent and in Combination With ASTX727 in Subjects With Relapsed/Refractory Acute Myeloid Leukemia (AML)
NCT04155580 ·Status: TERMINATED ·Phase: PHASE1
-
CCI-779 in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Myelodysplastic Syndromes, or Chronic Myelogenous Leukemia in Blastic Phase
NCT00084916 ·Status: COMPLETED ·Phase: PHASE2
-
Isatuximab in Combination With Chemotherapy in Pediatric Patients With Relapsed/Refractory Acute Lymphoblastic Leukemia or Acute Myeloid Leukemia
NCT03860844 ·Status: TERMINATED ·Phase: PHASE2
-
Tazemetostat and Palbociclib With CPX-351for R/R AML
NCT05627232 ·Status: RECRUITING ·Phase: PHASE1
-
Study of AMG 330 in Combination With Pembrolizumab in Adult With Relapsed or Refractory Acute Myeloid Leukemia
NCT04478695 ·Status: TERMINATED ·Phase: PHASE1
-
A Single-arm, Open-label Study of Olverembatinib, CD3/CD19 Bispecific T-cell Engager, and Chidamide in Patients With Newly Diagnosed Ph+ALL
NCT06220487 ·Status: RECRUITING ·Phase: PHASE2
-
Dose Escalation Study of JNJ-63709178, a Humanized CD123 x CD3 DuoBody in Participants With Relapsed or Refractory Acute Myeloid Leukemia (AML)
NCT02715011 ·Status: COMPLETED ·Phase: PHASE1
-
A Study of Decitabine (DACOGEN) in Sequential Administration With Cytarabine in Children With Relapsed or Refractory Acute Myeloid Leukemia
NCT01853228 ·Status: TERMINATED ·Phase: PHASE1/PHASE2
-
Study of Efficacy and Safety of CTL019 in Pediatric ALL Patients
NCT02228096 ·Status: COMPLETED ·Phase: PHASE2
-
First-in-Human Dose Escalation Study of AFM28 in Patients With Relapsed/Refractory Acute Myeloid Leukemia
NCT05817058 ·Status: TERMINATED ·Phase: PHASE1
-
A Study of MGD024 in Patients With Relapsed or Refractory Hematologic Malignancies
NCT05362773 ·Status: RECRUITING ·Phase: PHASE1
-
A Study to Evaluate the Efficacy and Safety of Daratumumab in Pediatric and Young Adult Participants Greater Than or Equal to (>=)1 and Less Than or Equal to (<=) 30 Years of Age With Relapsed/Refractory Precursor B-cell or T-cell Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma
NCT03384654 ·Status: COMPLETED ·Phase: PHASE2
-
Tafasitamab (MOR00208) in Pediatric Patients With Relapsed or Refractory Acute B Lineage Leukemia
NCT05366218 ·Status: RECRUITING ·Phase: PHASE1/PHASE2
-
A Second Infusion (Early Reinfusion) of Tisagenlecleucel in Children and Young Adults With B-Cell Acute Lymphoblastic Leukemia(B-ALL)
NCT05460533 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
ELU001 in Pediatric Subjects Who Have Relapsed and/or Refractory CBFA2T3-GLIS2-positive AML
NCT05622591 ·Status: WITHDRAWN ·Phase: PHASE1
-
Blinatumomab & Pembrolizumab for Adults With Relapsed/Refractory B-cell ALL With High Marrow Lymphoblasts
NCT03160079 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
A Phase II Study of Dasatinib in Children and Adolescents With Newly Diagnosed Chronic Phase Chronic Myelogenous Leukemia (CML) or With Ph+ Leukemias Resistant or Intolerant to Imatinib
NCT00777036 ·Status: COMPLETED ·Phase: PHASE2
-
Pharmacokinetic and Safety Study of MRX-2843 in Adolescents and Adults With Relapsed/Refractory AML, ALL, or MPAL
NCT04872478 ·Status: RECRUITING ·Phase: PHASE1
-
Study of Efficacy and Safety of Reinfusion of Tisagenlecleucel in Pediatric and Young Adult Patients With Acute Lymphoblastic Leukemia (ALL)
NCT04225676 ·Status: TERMINATED ·Phase: PHASE2