KRAS G12D-specific Immune Effector Cells Targeting KRAS G12D-positive Solid Tumors
NCT07924449, Not applicable, Not yet recruiting, Shenzhen Geno-Immune Medical Institute
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | KRAS G12D-specific Immune Effector Cells Targeting KRAS G12D-positive Solid Tumors | ClinicalTrials.gov |
| NCT number | NCT07924449 | ClinicalTrials.gov |
| Status | Not yet recruiting | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 30 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Shenzhen Geno-Immune Medical Institute | ClinicalTrials.gov |
| Conditions | Advanced Malignant Tumors With KRAS G12D Mutation | ClinicalTrials.gov |
| Interventions | KRAS G12D-EIEs | ClinicalTrials.gov |
| First posted | 2026-11-09 | ClinicalTrials.gov |
| Last updated | 2026-11-09 | ClinicalTrials.gov |
Registered outcomes 4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Percentage of adverse effects after KRAS G12D-EIE injection | up to one month | To assess the safety of autologous KRAS G12D-EIEs in vivo. The percentage of patients who have adverse effects will be evaluated by using the NCI CTCAE V4.0 criteria. | ClinicalTrials.gov |
| Secondary | Rate of successful KRAS G12D-EIE generation | up to one month | The percentage of successful KRAS G12D-EIE generation, which are derived from subjects and pass the safety test after standard culture procedures, viable for at least one preparation, will be evaluated. | ClinicalTrials.gov |
| Secondary | Ability of KRAS G12D-EIE cells to induce cancer-specific reactions | : after 1 month from KRAS G12D-EIE cell infusion until 24 months after infusion | ELISPOT measurement of target-specific T cells in blood sample | ClinicalTrials.gov |
| Secondary | Ability of KRAS G12D-EIE cells inducing tumor reduction | after 1 month from KRAS G12D-EIE cell infusion until 24 months after infusion | Objective response (complete response (CR) + partial response (PR)) will be assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria. CR is disappearance of all target lesions. Any pathological lesions (whether target or non-target) must have reduction in short axis to \<10 mm. Partial response is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.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.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)