Hematological Malignancies Clinical Trial
Official title:
A Phase 1, First-in-Human, Open-Label, Dose Escalation Study of Teclistamab, a Humanized BCMA x CD3 Bispecific Antibody in Subjects With Relapsed or Refractory Multiple Myeloma
The purpose of this study is to identify the recommended Phase 2 dose(s) (RP2Ds) and schedule assessed to be safe for Teclistamab and to characterize the safety and tolerability of Teclistamab at the RP2Ds.
The study will be conducted in 2 parts, separately for IV and SC administration: dose escalation (Part 1) and dose expansion (Part 2). It will evaluate safety, tolerability, pharmacokinetics and preliminary antitumor activity of Teclistamab administered to adult participants with relapsed or refractory multiple myeloma. The overall safety of the study drug will be assessed by physical examinations, Eastern Cooperative Oncology Group performance status, laboratory tests, vital signs, electrocardiograms, adverse event monitoring, and concomitant medication usage. Disease evaluations will include peripheral blood and bone marrow assessments at screening (performed within 28 days) and to confirm stringent complete response (sCR), complete response (CR), or relapse from CR. The end of study (study completion) is defined as 2 years after the last participant in Part 3 has received his or her initial dose of teclistamab. Study record NCT04557098 is Phase 2 part of this study and study record NCT03145181 is Phase 1 part of this study. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Terminated |
NCT03248479 -
Magrolimab Monotherapy or Magrolimab in Combination With Azacitidine in Participants With Hematological Malignancies
|
Phase 1 | |
| Recruiting |
NCT05454241 -
CD7 CAR-T for Patients With r/r CD7+ Hematologic Malignancies
|
Phase 2 | |
| Recruiting |
NCT06041815 -
Correlation Between Gut Microbiota and Clinical Response to CAR-T Treatment for Hematological Malignancies
|
||
| Active, not recruiting |
NCT05005442 -
A Study of Pembrolizumab/Vibostolimab (MK-7684A) in Relapsed/Refractory Hematological Malignancies (MK-7684A-004, KEYVIBE-004)
|
Phase 2 | |
| Recruiting |
NCT02300571 -
Observational Study of the Combination of Post-transplant High Dose Cyclophosphamide, Tacrolimus and Mycophenolate Mofetil for the Prevention of Acute Graft-versus-Host Disease in Patients Eligible to Allogeneic Hematopoietic Stem Cell Transplant
|
N/A | |
| Active, not recruiting |
NCT01428973 -
Minitransplants With HLA-matched Donors : Comparison Between 2 GVHD Prophylaxis Regimens
|
Phase 2 | |
| Completed |
NCT00379587 -
Rituximab for Prevention of Chronic GVHD
|
Phase 1/Phase 2 | |
| Completed |
NCT01162096 -
Reduced Intensity Haploidentical Transplant for Hematological Malignancies
|
Phase 1/Phase 2 | |
| Terminated |
NCT00506948 -
Thymoglobulin, Sirolimus and Mycophenolate Mofetil for Prevention of Acute Graft-Versus-Host Disease (GVHD)
|
Phase 2 | |
| Active, not recruiting |
NCT04557098 -
A Study of Teclistamab in Participants With Relapsed or Refractory Multiple Myeloma
|
Phase 2 | |
| Recruiting |
NCT04283097 -
Safety, Tolerability and Pharmacokinetics Study of KPG-818 in Hematological Malignancies Subjects
|
Phase 1 | |
| Completed |
NCT03067155 -
CMV Specific T Cell Therapy After Allogeneic Stem Cell Transplantation.
|
Phase 2 | |
| Completed |
NCT01725555 -
A Study to Assess the Effect of Food on the Bioavailability of the IGF-1R Inhibitor AXL1717 in Patients With Advanced Malignant Tumors
|
Phase 1 | |
| Completed |
NCT00438178 -
Safety and Efficacy of Obatoclax Mesylate (GX15-070MS) for the Treatment of Hematological Malignancies
|
Phase 1 | |
| Completed |
NCT03711604 -
Compassionate Use Study of Tenalisib (RP6530)
|
Phase 1/Phase 2 | |
| Withdrawn |
NCT01168882 -
Safety and Tolerability of RGB-286638 in Patients With Selected, Relapsed or Refractory Hematological Malignancies
|
Phase 1 | |
| Completed |
NCT01246206 -
Tacrolimus and Thymoglobulin, as GvHD Prophylaxis in Patients Undergoing Related Donor HCT
|
Phase 2 | |
| Completed |
NCT01172132 -
The Use of Intensive Care in Critically Ill Cancer Haematological Patients: "TRIAL-OH"
|
N/A | |
| Completed |
NCT00506402 -
A Phase 1 Study of MKC-1 in Patients With Refractory Hematologic Malignancies
|
Phase 1 | |
| Active, not recruiting |
NCT00163644 -
RCT to Investigate Whether an Exercise Programme Improves the Physical Performance and QOL After BMT
|
N/A |