IDP-023 as a Single Agent and in Combination With Antibody Therapies in Patients With Advanced Hematologic Cancers

Condition(s) studied

Investigational drug(s) / intervention(s)

IDP-023: NK cell therapy

Rituximab: Anti-CD20 antibody therapy

Daratumumab: Anti-CD38 antibody therapy

Interleukin-2: Immune cytokine

Cyclophosphamide: Lymphodepleting chemotherapy

Fludarabine: Lymphodepleting chemotherapy

Mesna: Chemoprotectant

Isatuximab: Anti-CD38 antibody therapy

Study summary

This is an open label, Phase 1/2, first-in-human, multiple ascending dose, and dose-expansion study of IDP-023 administered as a single agent and in combination with or without interleukin-2 (IL-2), and with or without isatuximab, daratumumab or rituximab to evaluate the safety, tolerability and preliminary antitumor activity in patients with advanced hematologic cancers.

Eligibility

Primary outcome measure(s)

• Incidence of adverse events (AEs) and serious adverse events (SAEs) - (Phase 1) — 1 year
  Escalation Period
• Incidence of dose-limiting toxicities (DLTs) of IDP-023 Monotherapy - (Phase 1) — up to 21 days
  Escalation Period
• Nature of dose-limiting toxicities (DLTs) of IDP-023 Monotherapy - (Phase 1) — up to 21 days
  Escalation Period
• Incidence of dose-limiting toxicities (DLTs) of IDP-023 in combination with Isatuximab, Daratumumab or Rituximab - (Phase 1) — up to 35 days
  Escalation Period
• Nature of dose-limiting toxicities (DLTs) of IDP-023 in combination with Isatuximab, Daratumumab or Rituximab - (Phase 1) — up to 35 days
  Escalation Period
• Maximum tolerable dose (MTD) or a tolerated dose below MTD - (Phase 1) — 1 year
  Escalation Period
• For MM: Anti-tumor activity by objective response rate (ORR), complete response (CR), stringent complete response (sCR), very good partial response (VGPR), and partial response (PR) - (Phase 2) — 2 years
  Expansion period
• For NHL: Anti-tumor activity by objective response rate (ORR) - (Phase 2) — 2 years
  Expansion period

Trial sites (12)