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Closed (no longer recruiting)Last updated: 9 January 2024

This Phase I trial is evaluating the safety of a targeted therapy drug (IGM-2323) in people with relapsed or refractory Non-Hodgkin LymphomaA 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

Clinical summary

Summary

This is a non-randomised, open label study consisting 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). In the Dose Escalation phase, participants 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. In the Dose Expansion phase, participants 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.

Conditions

This trial is treating patients with Non-Hodgkin Lymhoma

Cancer

Blood Cancers Haematological

Age

People18+

Phase

I

More information

Trial Identifiers

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Trial sponsor

IGM Biosciences, Inc.

Scientific Title

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

Eligibility

Inclusion

  • > 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). FL/MZL may be enrolled with a least 2 prior systemic regimens which must include an anti-CD20, without the need for a prior chemotherapy 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.

Exclusion

  • Prior allogeneic transplant
  • ASCT within 100 days prior to the first imvotamab administration.
  • 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 imvotamab, and prior CAR-T therapy only allowed with Medical Monitor approval.
  • Concurrent serious co-morbidities that could limit patients full participation and compliance.
  • Prior CD-targeting bispecific antibodies.
  • Prior loncastuximab tesirine.

Inclusion

  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
  • Your cancer has not spread to other parts of the body.

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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