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A Safety and Pharmacokinetic Study of IGM-2323 in Subjects With Relapsed/Refractory Non-Hodgkin Lymphoma

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ClinicalTrials.gov Identifier: NCT04082936
Recruitment Status : Recruiting
First Posted : September 10, 2019
Last Update Posted : May 19, 2021
Sponsor:
Information provided by (Responsible Party):
IGM Biosciences, Inc.

Tracking Information
First Submitted Date  ICMJE September 4, 2019
First Posted Date  ICMJE September 10, 2019
Last Update Posted Date May 19, 2021
Actual Study Start Date  ICMJE September 30, 2019
Estimated Primary Completion Date September 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 5, 2019)
Overall Frequency of Adverse Events [ Time Frame: Baseline through approximately 30 days after last study treatment ]
Percentage of Adverse Events
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 5, 2019)
  • Objective Response Rate (ORR) [ Time Frame: Baseline up to 1 year ]
    Percentage of measurable disease in subjects who have achieved either complete response (CR) or partial response (PR)
  • Duration of Response (DOR) [ Time Frame: Baseline up to 4 years ]
    measured from time of initial response until documented tumor progression
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Safety and Pharmacokinetic Study of IGM-2323 in Subjects With Relapsed/Refractory Non-Hodgkin Lymphoma
Official Title  ICMJE A Phase 1 Open-label, Multicenter Study Evaluating the Safety and Pharmacokinetics of Escalating Doses of IGM-2323 in Subjects With Relapsed/Refractory Non-Hodgkin Lymphoma
Brief Summary

This is a Phase 1 study of IGM-2323 in adult subjects with relapsed or refractory B-cell Non-Hodgkin Lymphoma. This study will consist of a dose-escalation stage and a dose-expansion stage where subjects will be enrolled into indication-specific expansion cohorts. IGM-2323 will be administered intravenously (IV).

Additional CD20-positive NHL histologies (e.g. MZL and MCL), may be allowed with Medical Monitor approval during the Dose-Escalation Phase of the study.

Detailed Description

IGM-2323 is an engineered bispecific IgM antibody for the treatment of patients with CD20-positive cancers. It contains ten high affinity binding domains for CD20, and one binding domain for CD3. IGM-2323 is able to eliminate CD20-positive lymphoma cells by engaging T-cells and lymphoma cells, leading to T-cell dependent cellular cytotoxicity. Additionally, IGM-2323 is also able to eliminate lymphoma cells by recruiting complement to the surface of lymphoma cells, leading to complement dependent cytotoxicity.

In our preclinical studies, we observed activity against rituximab resistant cells carrying low levels of CD20. We have also observed much lower cytokine release with IGM-2323 relative to comparable IgG format bispecific T-cell engaging antibodies, which is expected to result in reduced risk of the serious adverse effects from cytokine release syndrome (CRS).

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Non-Hodgkin Lymphoma
  • Follicular Lymphoma
  • DLBCL
  • Mantle Cell Lymphoma
  • Marginal Zone Lymphoma
Intervention  ICMJE Drug: IGM-2323
Subjects with r/r B-cell NHL will receive IGM-2323 via IV infusion.
Study Arms  ICMJE
  • Experimental: Part 1: Dose-Escalation Phase
    Subjects will receive IGM-2323 via intravenous (IV) infusion on Days 1, 8, and 15, of 21-day cycles. Subjects will be treated with 4 cycles (3 weeks each). Subjects benefiting from therapy can receive up to 8 cycles or longer with good response. Dose escalation will be guided by the observed incidence of DLTs at each dose level.
    Intervention: Drug: IGM-2323
  • Experimental: Part 2: Dose-Expansion Phase
    Subjects will receive IGM-2323 via intravenous (IV) infusion at a RP2D dose and schedule to be determined after reviewing all available response and safety data.
    Intervention: Drug: IGM-2323
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 5, 2019)
160
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2021
Estimated Primary Completion Date September 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Key Inclusion Criteria:

  • > 18 years of age: ECOG PS 0 or 1
  • Relapsed or Refractory Follicular Lymphoma (FL), and Diffuse Large B-cell Lymphoma (DLBCL), Mantle cell Lymphoma (MCL), Marginal Zone Lymphoma (MZL) in dose escalation
  • Relapsed or refractory to at least two prior systemic treatment regimens (must include anti-CD20 chemo-immunotherapy regimen).
  • At least one bi-dimensionally measurable lesion (>1.5cm in it's longest dimension by computerized tomography (CT scan)
  • Good organ function
  • Not eligible for autologous stem cell transplant (DLBCL subjects), due to chemoresistant disease, medically unfit (organ function), or unwilling.

Key Exclusion Criteria:

  • Prior allogeneic transplant
  • ASCT within 100 days prior to the first IGM-2323 administration.
  • Prior treatment with CD3 engaging bispecific antibodies.
  • Lack of response to prior treatment with CAR-T therapy, subjects with less than 3 months from prior CAR-T therapy to first dose of IGM-2323, and prior CAR-T therapy only allowed with Medical Monitor approval.
  • Concurrent serious co-morbidities that could limit patients' full participation and compliance
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Iris Sison 510-329-9857 clinicaltrials@IGMbio.com
Listed Location Countries  ICMJE Australia,   Korea, Republic of,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04082936
Other Study ID Numbers  ICMJE IGM-2323-001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party IGM Biosciences, Inc.
Study Sponsor  ICMJE IGM Biosciences, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Wayne Godfrey, M.D. IGM Biosciences, Inc.
PRS Account IGM Biosciences, Inc.
Verification Date May 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP