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

ConditionsNHLMultiple MyelomaBlood CancerRefractory Non-Hodgkin LymphomaRelapsed Non-Hodgkin LymphomaRefractory Multiple MyelomaRelapsed Multiple Myeloma
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorIndapta Therapeutics, INC.

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

For MM patients: Documented diagnosis of MM requiring systemic therapy and relapsed and/or refractory (R/R) disease after ≥ 3 prior lines of therapy.

For NHL patients: R/R disease and failed ≥ 2 lines of systemic chemotherapy.

Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

Life expectancy of greater than 12 weeks per the Investigator.

Disqualifiers

Impaired cardiac function or history of clinical significant cardiac disease.

Human immunodeficiency virus (HIV) infection, active hepatitis B infection, or hepatitis C infection.

Active SARS-CoV-2 infection.

Has untreated central nervous system, epidural tumor metastasis, or brain metastasis.

Trial design

Design model

Parallel

Treatments tested in this trial

  • IDP-023

    Drug

    NK cell therapy

  • Rituximab

    Drug

    Anti-CD20 antibody therapy

  • Daratumumab

    Drug

    Anti-CD38 antibody therapy

  • Interleukin-2

    Drug

    Immune cytokine

  • Cyclophosphamide

    Drug

    Lymphodepleting chemotherapy

  • Fludarabine

    Drug

    Lymphodepleting chemotherapy

  • Mesna

    Drug

    Chemoprotectant

  • Isatuximab

    Drug

    Anti-CD38 antibody therapy

Treatment groups

128 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Group A: Phase 1: Single Agent IDP-023 - Single DoseExperimental treatment 4 interventions
Group B: Phase 1: Single Agent IDP-023 - Multiple DosesExperimental treatment 4 interventions
Group C: Phase 1: Single Agent IDP-023 - Multiple Doses with IL-2Experimental treatment 5 interventions
Group D: Phase 2: Combination IDP-023 plus rituximabExperimental treatment 6 interventions
Group E: Phase 2: Combination IDP-023 plus daratumumabExperimental treatment 6 interventions
Group F: Phase 2: Combination IDP-023 plus isatuximabExperimental treatment 6 interventions

Trial outcomes

Primary outcomes

1

Incidence of adverse events (AEs) and serious adverse events (SAEs) - (Phase 1)

Escalation Period

Time frame
1 year
2

Incidence of dose-limiting toxicities (DLTs) of IDP-023 Monotherapy - (Phase 1)

Escalation Period

Time frame
up to 21 days
3

Nature of dose-limiting toxicities (DLTs) of IDP-023 Monotherapy - (Phase 1)

Escalation Period

Time frame
up to 21 days
4

Incidence of dose-limiting toxicities (DLTs) of IDP-023 in combination with Isatuximab, Daratumumab or Rituximab - (Phase 1)

Escalation Period

Time frame
up to 35 days

Secondary outcomes

1

PK (Cmax) of IDP-023 - (Phase 1/2)

Escalation and expansion periods

Time frame
2 years
2

PK (AUC) of IDP-023 - (Phase 1/2)

Escalation and expansion periods

Time frame
2 years
3

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 1)

Escalation period

Time frame
1 year
4

For NHL: Anti-tumor activity by objective response rate (ORR) - (Phase 1)

Escalation period

Time frame
1 year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Indapta Therapeutics, INC.

Lead sponsor

Source ClinicalTrials.gov
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