Health TrialsbyHealthPanel

Study of HuL001 in Relapsed/Refractory Multiple Myeloma Patients

ConditionMultiple Myeloma Refractory
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorHuniLife Biotechnology, Inc.

About this trial

The goal of this clinical trial is to learn if the antibody drug HuL001, combined with

Lenalidomide/Dexamethasone works to treat Multiple Myeloma patients. It will also learn about the safety and tolerability of the therapeutic combination. The objectives of this study are:

1. To evaluate the safety and tolerability of HuL001 (in combination with Len/Dex). 2. To evaluate the efficacy of HuL001 (in combination with Len/Dex).

Researchers will use the antibody drug HuL001, combined with Len/Dex, to see if this works for Multiple Myeloma therapy.

Participants will:

* Receive HuL001 antibody injections every 2 weeks * Take Lenalidomide for 21 consecutive days each month * Take Dexamethasone every 1 week * Visit the clinic on scheduled days for checkups and tests * Keep a diary of their symptoms and Myeloma responses.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Subjects aged 18 (inclusive) or older.

Confirmed diagnosis of RRMM according to the IMWG guidelines (International Myeloma Working Group updated criteria for the diagnosis of multiple myeloma, 2016).

Serum M-protein level ≥ 0.5 g/dL.

Urine M-protein level ≥ 200 mg/24 hours.

Disqualifiers

Suspected or known contraindication or intolerant reaction to lenalidomide and/or dexamethasone.

Suspected or known hypersensitivity (including allergy) to any of the components of the HuL001, lenalidomide, or dexamethasone.

Previous history of anaphylaxis and severe allergic reaction, generation of neutralizing antibodies, or hypersensitivity to albumin or a protein-based therapeutic, or any other mAb.

Planning to receive the HCT during the study period (approximately 6 months following the first dose of HuL001).

Trial design

Design model

Sequential

Treatments tested in this trial

  • HuL001

    Drug

    Anti-ENO1 monoclonal antibody

  • Lenalidomide/Dexamethasone

    Drug

    Lenalidomide in combination with dexamethasone is indicated for the treatment of adult patients with multiple myeloma (MM)

Treatment groups

21 Participants
are divided into 1 treatment group
Group A: HuL001 with Lenalidomide/DexamethasoneExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Myeloma responses, including sCR, CR, VGPR, PR, MR, SD, PD, clinical relapse, ORR, CBR, DoR, time to sCR, time to CR, time to VGPR, time to PR, time to MR, as assessed by the investigator according to the IMWG criteria.

Complete Response (CR): Negative immunofixation on serum and urine, disappearance of any soft tissue plasmacytomas, and ≤ 5% plasma cells in the bone marrow. Very Good Partial Response (VGPR): ≥ 90% reduction in serum M-protein plus urine M-protein level \<100 mg/24 hours (or ≥ 90% reduction in serum free light chain difference if serum/urine M-proteins are unmeasurable). Partial Response (PR): ≥ 50% reduction in serum M-protein and reduction in 24-hour urine M-protein by ≥ 90% (or to \<200 mg/24 hours). If M-protein is unmeasurable, a ≥ 50% reduction in the difference between involved and uninvolved serum free light chains or bone marrow plasma cells. Minimal Response (MR): 25% to 49% reduction in serum M-protein and reduction in 24-hour urine M-protein by 50% to 89%. Stable Disease (SD): Does not meet criteria for PR, VGPR, CR, or progressive disease (not changing significantly). Progressive Disease (PD): Increase of \>25% from lowest response value in M-protein, serum fr

Time frame
From enrollment to the end of treatment at 8 months

Secondary outcomes

1

Safety parameters, including occurrence, severity, and relationship of the TEAEs, as assessed by the NCI-CTCAE version 5.0 during the study period.

All AEs and toxicities are evaluated based on the National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI-CTCAE) Version 5.0. The 5 general grades are Grade 1: Mild, Grade 2: Moderate, Grade 3: Severe, Grade 4: Life-threatening or disabling, and Grade 5: Death (outcome of AE).

Time frame
From enrollment to the end of treatment at 8 months
2

Immunogenicity

Immunogenicity: Anti-HuL001 antibodies (ADA).

Time frame
From enrollment to the end of treatment at 8 months

Other outcomes

Sponsors and contacts

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

HuniLife Biotechnology, Inc.

Lead sponsor

Source ClinicalTrials.gov
Apply now