NHLPhase 1/2NCT06119685
IDP-023 as a Single Agent and in Combination With Antibody Therapies in Patients With Advanced Hematologic Cancers
A Phase 1/2 study testing IDP-023, Rituximab and Daratumumab in people with NHL and Multiple Myeloma, run by Indapta Therapeutics, INC. at 12 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- NHL, Multiple Myeloma, Blood Cancer
- What is being tested?
- IDP-023, Rituximab and Daratumumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 12 sitesUnited States
- Study dates
- 25 Oct 2023to 31 Dec 2029
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
12 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Indapta Therapeutics, Inc. contact
12 sites in 1 country
United States12 sites, 9 recruiting
- Recruiting
Emory University Hospital
Atlanta, Georgia, 30322
- Recruiting
University Hospitals Cleveland
Cleveland, Ohio, 44106
UH Seidman Cancer Center Cancer Information Service Line, 844-885-9659
- Recruiting
NEXT Oncology Virginia
Fairfax, Virginia, 22031
Blake Patterson, 703-783-4505, bpatterson@nextoncology.com
- Recruiting
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
Christy Allen, 281-455-0250, callen6@mdanderson.org
- Withdrawn
Florida Cancer Specialists and Research Institute - Lake Mary Cancer Center
Lake Mary, Florida, 32746
- Recruiting
Valkyrie Clinical Trials
Los Angeles, California, 90670
Myo Zaw, 626-632-1963, myo.zaw@vctcare.com
- Recruiting
University of Minnesota
Minneapolis, Minnesota, 55455
Kayla Wagenmann, MN, RN, PHN, 612-624-2342, wage0074@umn.edu
- Recruiting
SCRI Oncology Partners
Nashville, Tennessee, 37203
Briana Smith, 615-329-7449, briana.smith@scri.com
- Withdrawn
NYP/Weill Cornell Medical Center
New York, New York, 10065
- Withdrawn
Providence Cancer Institute Franz Clinic
Portland, Oregon, 97213
- Recruiting
Rhode Island Hospital
Providence, Rhode Island, 02903
Stephen Donnelly, 401-444-4822, SDonnelly1@Lifespan.org
- Recruiting
Atrium Health Wake Forest Baptist
Winston-Salem, North Carolina, 27157
Catalina Gonzalez-Pinzon, 336-716-2957, cagonzal@wakehealth.edu
About this study
Official title: Phase 1/2 Study of IDP-023 as a Single Agent and in Combination With Antibody Therapies in Patients With Advanced Hematologic Cancers
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.
Read the detailed description
IDP-023 is an off-the-shelf, allogeneic cell product made of "natural killer" cells, also called NK cells. White blood cells are part of the immune system and NK cells are a type of white blood cell that are known to kill cancer cells.
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 relapsed and/or refractory advanced multiple myeloma (MM) or non-Hodgkin's lymphoma (NHL), respectively.
The study is divided into a phase 1 dose escalation phase and a phase 2 expansion phase.
Phase 1 (Escalation Phase): The primary objectives of Phase 1 are to define the safety of different IDP-023 containing regimens and to define the recommended regimen and Phase 2 doses (RP2D) of IDP-023.
Phase 2 (Expansion Phase): The objective of the Phase 2 expansion cohort is to evaluate the safety and efficacy of IDP-023 in advanced MM in combination with isatuximab or daratumumab and advanced NHL in combination with rituximab.
- Conditions
- NHL, Multiple Myeloma, Blood Cancer, Refractory Non-Hodgkin Lymphoma, Relapsed Non-Hodgkin Lymphoma, Refractory Multiple Myeloma
- Being tested
- IDP-023, Rituximab, Daratumumab, Interleukin-2, Cyclophosphamide
- Keywords
- Advanced Hematologic Cancers
- Medical subject headings
- Multiple Myeloma, Hematologic Neoplasms, Lymphoma, Non-Hodgkin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IDP-023Drug
NK cell therapy
RituximabDrug
Also called Rituxan
Anti-CD20 antibody therapy
DaratumumabDrug
Also called Darzalex
Anti-CD38 antibody therapy
Interleukin-2Drug
Also called Proleukin
Immune cytokine
CyclophosphamideDrug
Lymphodepleting chemotherapy
FludarabineDrug
Lymphodepleting chemotherapy
MesnaDrug
Chemoprotectant
IsatuximabDrug
Also called Sarclisa
Anti-CD38 antibody therapy
| Study group | Role | What they receive |
|---|---|---|
| Phase 1: Single Agent IDP-023 - Single Dose | Experimental | NHL or MM patient treated with a single dose of IDP-023 monotherapy Receives: Drug: IDP-023; Drug: Cyclophosphamide; Drug: Fludarabine; Drug: Mesna |
| Phase 1: Single Agent IDP-023 - Multiple Doses | Experimental | NHL and MM patients treated with multiple doses of IDP-023 monotherapy Receives: Drug: IDP-023; Drug: Cyclophosphamide; Drug: Fludarabine; Drug: Mesna |
| Phase 1: Single Agent IDP-023 - Multiple Doses with IL-2 | Experimental | NHL and MM patients treated with multiple doses of IDP-023 monotherapy Receives: Drug: IDP-023; Drug: Interleukin-2; Drug: Cyclophosphamide; Drug: Fludarabine; Drug: Mesna |
| Phase 2: Combination IDP-023 plus rituximab | Experimental | NHL patients treated with multiple doses of IDP-023 in combination with rituximab Receives: Drug: IDP-023; Drug: Rituximab; Drug: Interleukin-2; Drug: Cyclophosphamide; Drug: Fludarabine; Drug: Mesna |
| Phase 2: Combination IDP-023 plus daratumumab | Experimental | MM patients treated with multiple doses of IDP-023 in combination with daratumumab Receives: Drug: IDP-023; Drug: Daratumumab; Drug: Interleukin-2; Drug: Cyclophosphamide; Drug: Fludarabine; Drug: Mesna |
| Phase 2: Combination IDP-023 plus isatuximab | Experimental | MM patients treated with multiple doses of IDP-023 in combination with isatuximab Receives: Drug: IDP-023; Drug: Interleukin-2; Drug: Cyclophosphamide; Drug: Fludarabine; Drug: Mesna; Drug: Isatuximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events (AEs) and serious adverse events (SAEs) - (Phase 1)
Escalation Period
Measured: 1 year
Incidence of dose-limiting toxicities (DLTs) of IDP-023 Monotherapy - (Phase 1)
Escalation Period
Measured: up to 21 days
Nature of dose-limiting toxicities (DLTs) of IDP-023 Monotherapy - (Phase 1)
Escalation Period
Measured: up to 21 days
Incidence of dose-limiting toxicities (DLTs) of IDP-023 in combination with Isatuximab, Daratumumab or Rituximab - (Phase 1)
Escalation Period
Measured: up to 35 days
Nature of dose-limiting toxicities (DLTs) of IDP-023 in combination with Isatuximab, Daratumumab or Rituximab - (Phase 1)
Escalation Period
Measured: up to 35 days
Maximum tolerable dose (MTD) or a tolerated dose below MTD - (Phase 1)
Escalation Period
Measured: 1 year
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)
Expansion period
Measured: 2 years
For NHL: Anti-tumor activity by objective response rate (ORR) - (Phase 2)
Expansion period
Measured: 2 years
Secondary outcomes (5)
PK (Cmax) of IDP-023 - (Phase 1/2)
Escalation and expansion periods
Measured: 2 years
PK (AUC) of IDP-023 - (Phase 1/2)
Escalation and expansion periods
Measured: 2 years
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
Measured: 1 year
For NHL: Anti-tumor activity by objective response rate (ORR) - (Phase 1)
Escalation period
Measured: 1 year
Incidence of adverse events (AEs) and serious adverse events (SAEs) - (Phase 2)
Expansion period
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2023
- Study start25 Oct 2023
- Primary completion30 Dec 2025 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NHLStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Indapta Therapeutics, INC.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Indapta Therapeutics, Inc., Study director, Indapta Therapeutics, INC.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06119685
- Sponsor's protocol ID
- Indapta-Trial-1
- Status last verified
- Aug 2024
- First submitted
- 22 Oct 2023
- Last updated
- 3 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1/2 Study of IDP-023 as a Single Agent and in Combination With Antibody Therapies in Patients With Advanced Hematologic Cancers
- ClinicalTrials.gov ID
- NCT06119685
- Acronym / sponsor ID
- Indapta-Trial-1
- Conditions
- NHL, Multiple Myeloma, Blood Cancer, Refractory Non-Hodgkin Lymphoma, Relapsed Non-Hodgkin Lymphoma, Refractory Multiple Myeloma
- Keywords
- Advanced Hematologic Cancers
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- Indapta Therapeutics, INC.Industry (pharma, biotech, devices)
- Study start
- 25 Oct 2023 (actual)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 7 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
IDP-023 is an off-the-shelf, allogeneic cell product made of "natural killer" cells, also called NK cells. White blood cells are part of the immune system and NK cells are a type of white blood cell that are known to kill cancer cells.
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 relapsed and/or refractory advanced multiple myeloma (MM) or non-Hodgkin's lymphoma (NHL), respectively.
The study is divided into a phase 1 dose escalation phase and a phase 2 expansion phase.
Phase 1 (Escalation Phase): The primary objectives of Phase 1 are to define the safety of different IDP-023 containing regimens and to define the recommended regimen and Phase 2 doses (RP2D) of IDP-023.
Phase 2 (Expansion Phase): The objective of the Phase 2 expansion cohort is to evaluate the safety and efficacy of IDP-023 in advanced MM in combination with isatuximab or daratumumab and advanced NHL in combination with rituximab.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Phase 1: Single Agent IDP-023 - Single Dose | Experimental | Drug: IDP-023, Drug: Cyclophosphamide, Drug: Fludarabine, Drug: MesnaNHL or MM patient treated with a single dose of IDP-023 monotherapy |
| Phase 1: Single Agent IDP-023 - Multiple Doses | Experimental | Drug: IDP-023, Drug: Cyclophosphamide, Drug: Fludarabine, Drug: MesnaNHL and MM patients treated with multiple doses of IDP-023 monotherapy |
| Phase 1: Single Agent IDP-023 - Multiple Doses with IL-2 | Experimental | Drug: IDP-023, Drug: Interleukin-2, Drug: Cyclophosphamide, Drug: Fludarabine, Drug: MesnaNHL and MM patients treated with multiple doses of IDP-023 monotherapy |
| Phase 2: Combination IDP-023 plus rituximab | Experimental | Drug: IDP-023, Drug: Rituximab, Drug: Interleukin-2, Drug: Cyclophosphamide, Drug: Fludarabine, Drug: MesnaNHL patients treated with multiple doses of IDP-023 in combination with rituximab |
| Phase 2: Combination IDP-023 plus daratumumab | Experimental | Drug: IDP-023, Drug: Daratumumab, Drug: Interleukin-2, Drug: Cyclophosphamide, Drug: Fludarabine, Drug: MesnaMM patients treated with multiple doses of IDP-023 in combination with daratumumab |
| Phase 2: Combination IDP-023 plus isatuximab | Experimental | Drug: IDP-023, Drug: Interleukin-2, Drug: Cyclophosphamide, Drug: Fludarabine, Drug: Mesna, Drug: IsatuximabMM patients treated with multiple doses of IDP-023 in combination with isatuximab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IDP-023NK cell therapy | Drug | Phase 1: Single Agent IDP-023 - Multiple Doses, Phase 1: Single Agent IDP-023 - Multiple Doses with IL-2, Phase 1: Single Agent IDP-023 - Single Dose, Phase 2: Combination IDP-023 plus daratumumab, Phase 2: Combination IDP-023 plus isatuximab, Phase 2: Combination IDP-023 plus rituximab |
| RituximabAlso: RituxanAnti-CD20 antibody therapy | Drug | Phase 2: Combination IDP-023 plus rituximab |
| DaratumumabAlso: DarzalexAnti-CD38 antibody therapy | Drug | Phase 2: Combination IDP-023 plus daratumumab |
| Interleukin-2Also: ProleukinImmune cytokine | Drug | Phase 1: Single Agent IDP-023 - Multiple Doses with IL-2, Phase 2: Combination IDP-023 plus daratumumab, Phase 2: Combination IDP-023 plus isatuximab, Phase 2: Combination IDP-023 plus rituximab |
| CyclophosphamideLymphodepleting chemotherapy | Drug | Phase 1: Single Agent IDP-023 - Multiple Doses, Phase 1: Single Agent IDP-023 - Multiple Doses with IL-2, Phase 1: Single Agent IDP-023 - Single Dose, Phase 2: Combination IDP-023 plus daratumumab, Phase 2: Combination IDP-023 plus isatuximab, Phase 2: Combination IDP-023 plus rituximab |
| FludarabineLymphodepleting chemotherapy | Drug | Phase 1: Single Agent IDP-023 - Multiple Doses, Phase 1: Single Agent IDP-023 - Multiple Doses with IL-2, Phase 1: Single Agent IDP-023 - Single Dose, Phase 2: Combination IDP-023 plus daratumumab, Phase 2: Combination IDP-023 plus isatuximab, Phase 2: Combination IDP-023 plus rituximab |
| MesnaChemoprotectant | Drug | Phase 1: Single Agent IDP-023 - Multiple Doses, Phase 1: Single Agent IDP-023 - Multiple Doses with IL-2, Phase 1: Single Agent IDP-023 - Single Dose, Phase 2: Combination IDP-023 plus daratumumab, Phase 2: Combination IDP-023 plus isatuximab, Phase 2: Combination IDP-023 plus rituximab |
| IsatuximabAlso: SarclisaAnti-CD38 antibody therapy | Drug | Phase 2: Combination IDP-023 plus isatuximab |
Primary outcome
Incidence of adverse events (AEs) and serious adverse events (SAEs) - (Phase 1)
Time frame: 1 year
Escalation Period
Incidence of dose-limiting toxicities (DLTs) of IDP-023 Monotherapy - (Phase 1)
Time frame: up to 21 days
Escalation Period
Nature of dose-limiting toxicities (DLTs) of IDP-023 Monotherapy - (Phase 1)
Time frame: up to 21 days
Escalation Period
Incidence of dose-limiting toxicities (DLTs) of IDP-023 in combination with Isatuximab, Daratumumab or Rituximab - (Phase 1)
Time frame: up to 35 days
Escalation Period
Nature of dose-limiting toxicities (DLTs) of IDP-023 in combination with Isatuximab, Daratumumab or Rituximab - (Phase 1)
Time frame: up to 35 days
Escalation Period
Maximum tolerable dose (MTD) or a tolerated dose below MTD - (Phase 1)
Time frame: 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)
Time frame: 2 years
Expansion period
For NHL: Anti-tumor activity by objective response rate (ORR) - (Phase 2)
Time frame: 2 years
Expansion period
5 secondary outcomes
PK (Cmax) of IDP-023 - (Phase 1/2)
Time frame: 2 years
PK (AUC) of IDP-023 - (Phase 1/2)
Time frame: 2 years
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)
Time frame: 1 year
For NHL: Anti-tumor activity by objective response rate (ORR) - (Phase 1)
Time frame: 1 year
Incidence of adverse events (AEs) and serious adverse events (SAEs) - (Phase 2)
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Indapta Therapeutics, Inc. contact
Indapta Therapeutics, Inc. study director
Indapta Therapeutics, INC.
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing IDP-023, Rituximab and Daratumumab in people with NHL and Multiple Myeloma, run by Indapta Therapeutics, INC. at 12 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Indapta Therapeutics, Inc. (TRIALS@INDAPTA.COM), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of adverse events (AEs) and serious adverse events (SAEs) - (Phase 1) (time frame: 1 year). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2025.