IMGN632 for BPDCN
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new treatment called IMGN632, an experimental drug for certain blood cancers, including blastic plasmacytoid dendritic cell neoplasm (BPDCN), acute myeloid leukemia (AML), and acute lymphoblastic leukemia (ALL). The main goal is to assess the safety and effectiveness of this treatment in patients whose cancer has returned or not responded to previous treatments. The trial is open to participants with relapsed or difficult-to-treat blood cancers that have a specific marker called CD123. Those who have had prior treatments and whose cancer fits these criteria might find this trial suitable. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new therapy.
Will I have to stop taking my current medications?
The trial protocol does not specify if you must stop taking your current medications. However, you must not have received any anti-cancer therapy, including chemotherapy, immunotherapy, or radiotherapy, within 14 days before starting the study. If you have taken a checkpoint inhibitor, you must wait 28 days before starting the study.
Is there any evidence suggesting that IMGN632 is likely to be safe for humans?
Research has shown that IMGN632 is generally safe. Studies have found that patients, including those with BPDCN, a rare blood cancer, usually tolerate it well. In earlier studies, patients experienced manageable side effects, and the drug performed effectively without causing serious problems. While some side effects are expected, they were neither surprising nor too severe for this type of treatment. Overall, IMGN632 appears to be a promising option, with safety data indicating it is manageable for patients.12345
Why do researchers think this study treatment might be promising?
IMGN632 is unique because it targets CD123, a protein commonly found on the surface of cancer cells in BPDCN (Blastic Plasmacytoid Dendritic Cell Neoplasm). This targeted approach could mean less harm to healthy cells compared to traditional chemotherapy, which often affects both cancerous and healthy cells. Additionally, IMGN632 is delivered intravenously, allowing it to circulate quickly and efficiently throughout the body, potentially leading to faster and more effective treatment outcomes. Researchers are excited about IMGN632 because it promises a more focused attack on cancer cells, which could result in improved response rates and fewer side effects for patients with BPDCN.
What evidence suggests that IMGN632 might be an effective treatment for BPDCN?
Research shows that IMGN632, the investigational treatment in this trial, may help treat blastic plasmacytoid dendritic cell neoplasm (BPDCN). In studies with patients whose BPDCN returned or did not respond to other treatments, IMGN632 demonstrated promising safety and effectiveness. The data highlights its ability to target CD123, a protein often found on cancer cells, aiding in fighting the disease. While results can vary, the treatment has been effective at various doses. Overall, these findings offer hope for those seeking new treatment options for BPDCN.34678
Who Is on the Research Team?
ABBVIE INC.
Principal Investigator
AbbVie
Are You a Good Fit for This Trial?
This trial is for patients with a rare blood cancer called BPDCN. It's open to those who have never had systemic treatment (Cohort 6) or have tried up to three treatments without success (Cohort 1). Participants must show CD123+ on their cancer cells and can't join if they've got CNS disease, severe swelling issues, liver veno-occlusive disease, or suitable standard care options available.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
IMGN632 is administered by IV on Day 1 of each cycle, with cycles repeating every 21 days
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- IMGN632
Trial Overview
The study tests IMGN632 as a solo treatment for BPDCN. Researchers want to find the highest dose patients can take without serious side effects (MTD), how safe it is, how the body processes it, if it causes immune reactions, and its effectiveness against leukemia.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Escalation: IMGN632 was administered by IV on 2 different schedules for participants with relapsed/refractory AML, ALL, or BPDCN. Expansion: IMGN632 was administered by IV: * Cohort 1: Relapsed or refractory BPDCN participants who have received 1-3 prior systemic therapies (incl. tagraxofusp-erzs and/or any other systemic therapy deemed appropriate for the treatment of BPDCN) * Cohort 2: Relapsed AML * Cohort 3: Relapsed or refractory ALL * Cohort 4: Other relapsed or refractory hematologic malignancies * Cohort 5: Relapsed or refractory AML at alternate dose or schedule * Cohort 6: Pivotal cohort for frontline BPDCN participants who have not received prior systemic therapy and participants with frontline BPDCN who have prior or concomitant hematologic malignancy (PCHM) and have not received prior systemic therapy.
Find a Clinic Near You
Who Is Running the Clinical Trial?
AbbVie
Lead Sponsor
Dr. Roopal Thakkar
AbbVie
Chief Medical Officer since 2023
MD from Wayne State University School of Medicine
Robert A. Michael
AbbVie
Chief Executive Officer
Bachelor's degree in Finance from the University of Illinois
ImmunoGen, Inc.
Lead Sponsor
Citations
ImmunoGen Presents Updated Findings from Phase 1/2 ...
These updated safety and efficacy findings for IMGN632 in patients with relapsed/refractory BPDCN are encouraging, and I look forward to ...
Clinical Profile of IMGN632, a Novel CD123-Targeting ...
In this phase 1 trial, the novel CD123-targeting ADC IMGN632 demonstrated a manageable safety profile and broad therapeutic window in high risk R/R AML and ...
Breakthrough in Blastic Plasmacytoid Dendritic Cell ...
The outcomes of this study, encompassing both safety and efficacy data, may potentially pave the way for exploring IMGN632 combinations in the context of ...
NCT03386513 | Study of IMGN632 in Patients With ...
This is an open-label, multi-center, Phase 1/2 study to determine the MTD and assess the safety, tolerability, PK, immunogenicity, and anti-leukemia ...
167 Clinical Profile of IMGN632, a Novel CD123-Targeting ...
Despite the recent approval of tagraxofusp-erzs (Pemmaraju NEJM 2019), outcomes remain poor in the setting of R/R BPDCN. IMGN632 is a CD123- ...
6.
ashpublications.org
ashpublications.org/blood/article/138/Supplement%201/4429/482269/A-Study-of-IMGN632-a-Novel-CD123-TargetingA Study of IMGN632, a Novel CD123-Targeting Antibody-Drug ...
Importantly IMGN632 has demonstrated favorable safety profile and has demonstrated evidence of promising efficacy in patients with BPDCN (ASH ...
S139: INTERIM ANALYSIS OF A REGISTRATION ...
Aims: To report an interim analysis of safety and anti-tumor activity data in frontline BPDCN pts and updated data on R/R BPDCN pts. Methods: In ...
Pivekimab sunirine (IMGN632), a novel CD123-targeting ...
Pivekimab sunirine (IMGN632) is a first-in-class antibody–drug conjugate comprising a high-affinity CD123 antibody, cleavable linker, and novel ...
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