IMGN632 for BPDCN

Recruiting at 27 trial locations

Overseen By ImmunoGen Clinical Trials

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: AbbVie

Must not be taking: Checkpoint inhibitors

Disqualifiers: CNS disease, Veno-occlusive disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 21-day cycles

179 Participants Needed

Trial Summary

What is the purpose of this trial?

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 activity of IMGN632 when administered as monotherapy to patients with CD123+ disease.

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.

How does the drug IMGN632 differ from other treatments for BPDCN?

IMGN632 is a novel drug for BPDCN (Blastic Plasmacytoid Dendritic Cell Neoplasm) that may offer a unique mechanism of action compared to existing treatments, although specific details about its uniqueness are not provided in the available research. ^{1 2 3 4 5}

Research Team

ABBVIE INC.

Principal Investigator

AbbVie

Eligibility Criteria

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

I have BPDCN and have undergone 1-3 treatments.

My AML has returned or didn't respond to initial mild treatments and tests positive for CD123.

I have BPDCN and haven't had any systemic therapy yet.

Exclusion Criteria

My doctor thinks standard treatments are right for me, so I'm not eligible for Cohorts 1-5.

I have BPDCN that has spread to my brain or spinal cord.

I haven't had cancer treatment in the last 14 days and have recovered from any side effects.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

IMGN632 is administered by IV on Day 1 of each cycle, with cycles repeating every 21 days

21-day cycles

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 24 months

Treatment Details

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.

Participant Groups

Group I: Escalation and Expansion Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

AbbVie

Lead Sponsor

Trials

1,079

Recruited

535,000+

Founded

2013

Headquarters

North Chicago, USA

Known For

Immunology treatments

Top Products

Humira (adalimumab), Skyrizi (risankizumab), Rinvoq (upadacitinib)

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

Trials

33

Recruited

4,000+

References

1. China pubmed.ncbi.nlm.nih.gov

Protection of immuno-compromised mice from lethal infection of Klebsiella pneumonia by rAAV2-BPI23-Fcgamma1 gene transfer. [2021]

2. England pubmed.ncbi.nlm.nih.gov

The roles of the glycosylphosphatidylinositol anchor on the production and immunogenicity of recombinant ookinete surface antigen Pbs21 of Plasmodium berghei when prepared in a baculovirus expression system. [2019]

3. England pubmed.ncbi.nlm.nih.gov

Infecting mice with recombinant Ad5-BPI₂₃-Fcγ1 virus protects against systemic Escherichia coli challenge. [2020]

4. India pubmed.ncbi.nlm.nih.gov

Construction of recombinant polypeptides based on beta antigen C (Bac) protein & their usage for protection against group B streptococcal infection. [2013]

5. Germany pubmed.ncbi.nlm.nih.gov

Functional mapping of the Fc gamma RII binding site on human IgG1 by synthetic peptides. [2018]