Trial · NCT06450041
NANT 2021-01 Phase II STING (Sequential Temozolomide, Irinotecan, NK Cells and GD2 mAb) Trial
NCT06450041, Phase 2, Recruiting, New Approaches to Neuroblastoma Therapy Consortium
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. NANT 2021-01 Phase II STING (Sequential Temozolomide, Irinotecan, NK Cells and GD2 mAb) Trial. Trials, record NCT06450041. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06450041
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- NANT 2021-01 Phase II STING (Sequential Temozolomide, Irinotecan, NK Cells and GD2 mAb) Trial
- NCT number
- NCT06450041
- Status
- Recruiting
- Phases
- Phase 2
- Enrollment
- 62 participants, estimated
- Lead sponsor
- New Approaches to Neuroblastoma Therapy Consortium
- Conditions
- Neuroblastoma
- Interventions
- Universal Donor (UD) TGFβi NK Cells, Temozolomide, Irinotecan, Dinutuximab, GM-CSF
- First posted
- 2024-06-10
- Last updated
- 2026-07-20
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Best Overall Response Rate of Evaluable Patients | Baseline assessments from within 28 days before Day 1 on study and between days 12-24 of cycles 2, 4, and 6, and within two weeks after the last date of protocol therapy. Each cycle will be 21 days but may be extended to 28 days due to treatment delays. | The response evaluation is based on central review or site review (when central review is not available) of patient diagnostic assessments. Response is determined by the NANT response criteria v2.0 (https://doi.org/10.1002/pbc.26940). 1. Complete response 2. Partial response 3. Minor response 4. Stable response 5. Progressive disease 6. Early death from malignant disease 7. Early death from toxicity Evaluable response patients have received sufficient therapy (1) and have sufficient response evaluation data to assess best overall response (2) including patients in categories f and g 1. is defined as at least 75% of all therapeutic agents in course 1, or less than 75% in course 1 due to clinical signs of tumor progression or therapy related toxicity. 2. is defined as presence of a disease evaluation for each of the 3 disease parameters (bone, soft tissue, bone marrow) at one or more timepoints after enrollment. Best Overall Response Rate = (a+b+c)/ (a+b+c+d+e+f+g). |
| Secondary | Proportion of Evaluable Participants with Grade 3 or Greater Hematologic Toxicities or Any Hematologic Toxicities Attributed to this therapy. | All toxicities from enrollment through 30 days following end of protocol therapy, an average of 6 months | Describe the toxicity profiles for grade 3 or greater hematologic toxicities associated with the protocol therapy any hematologic toxicities attributed to NK cells. All patients who start treatment for this protocol are evaluable for toxicity reporting. |
| Secondary | Proportion of Evaluable of Participants with Grade 2 or Greater Non-Hematologic Toxicities or Any Non-Hematologic Toxicities Attributed to this therapy. | All toxicities from enrollment through 30 days following end of protocol therapy, an average of 6 months | Describe the toxicity profiles for grade 2 or greater non-hematologic toxicities associated with the protocol therapy any non-hematologic toxicities attributed to NK cells. All patients who start treatment for this protocol are evaluable for toxicity reporting |
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/NCT06450041
GET https://conductscience.org/api/trials/v1/NCT06450041/registered