Trial · NCT07210047
Study of HuL001 in Relapsed/Refractory Multiple Myeloma Patients
NCT07210047, Phase 1, Phase 2, Recruiting, HuniLife Biotechnology, Inc.
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study of HuL001 in Relapsed/Refractory Multiple Myeloma Patients. Trials, record NCT07210047. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07210047
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of HuL001 in Relapsed/Refractory Multiple Myeloma Patients
- NCT number
- NCT07210047
- Status
- Recruiting
- Phases
- Phase 1, Phase 2
- Enrollment
- 21 participants, estimated
- Lead sponsor
- HuniLife Biotechnology, Inc.
- Conditions
- Multiple Myeloma Refractory
- Interventions
- HuL001, Lenalidomide/Dexamethasone
- First posted
- 2025-10-07
- Last updated
- 2026-09-18
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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. | From enrollment to the end of treatment at 8 months | 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 |
| Secondary | Safety parameters, including occurrence, severity, and relationship of the TEAEs, as assessed by the NCI-CTCAE version 5.0 during the study period. | From enrollment to the end of treatment at 8 months | 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). |
| Secondary | Immunogenicity | From enrollment to the end of treatment at 8 months | Immunogenicity: Anti-HuL001 antibodies (ADA). |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07210047
GET https://conductscience.org/api/trials/v1/NCT07210047/registered