Trial · NCT06986382
Phase 1b/2a Trial of Allogeneic HSCT From an HLA-partially Matched Related or Unrelated Donor After TCRab+ T-cell/CD19+ B-cell Depletion for Patients With Monogenic and/or Early-onset Medically Refractory Crohn Disease
NCT06986382, Phase 1, Phase 2, Not yet recruiting, Stanford University
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Phase 1b/2a Trial of Allogeneic HSCT From an HLA-partially Matched Related or Unrelated Donor After TCRab+ T-cell/CD19+ B-cell Depletion for Patients With Monogenic and/or Early-onset Medically Refractory Crohn Disease. Trials, record NCT06986382. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06986382
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
Phase 1b/2a Trial of Allogeneic HSCT From an HLA-partially Matched Related or Unrelated Donor After TCRab+ T-cell/CD19+ B-cell Depletion for Patients With Monogenic and/or Early-onset Medically Refractory Crohn Disease
- NCT number
- NCT06986382
- Status
- Not yet recruiting
- Phases
- Phase 1, Phase 2
- Enrollment
- 14 participants, estimated
- Lead sponsor
- Stanford University
- Conditions
- Crohn Disease
- Interventions
- CliniMACS® TCR α/β Reagent Kit and CliniMACS® CD19 System, Prednisone/Methylprenisolone, Palifermin, ATG, Clofarabine, Melphalan, Total Body Irradiation, Rituximab
- First posted
- 2025-05-23
- Last updated
- 2025-05-23
Source ClinicalTrials.gov
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of patients with myeloid engraftment | Day 42 post-HSCT | Cumulative incidence of donor myeloid engraftment by Day +42 post-HSCT. Myeloid engraftment is defined as ANC of \> 0.5 x 109/L for three consecutive laboratory values obtained on different days. Date of myeloid engraftment is the first date of the three lab values taken. |
| Primary | Number of patients with Grade III-IV acute graft vs host disease (GVHD) | Day 90 and 180 post-HSCT | Cumulative incidence of acute GvHD (graded as II-IV and III-IV using the Magic criteria) Cumulative incidence of acute GvHD (graded as II-IV and III-IV using the Magic criteria) Cumulative incidence of acute GvHD (graded as II-IV and III-IV using the Magic criteria) Cumulative incidence of acute GvHD (graded using the Magic criteria) |
| Primary | Number of patients in remission of Crohn disease (Calprotectin) | 2 years post-HSCT | Cumulative incidence of patient who achieve remission defined by fecal calprotectin values less than 250 mg/g |
| Primary | Number of patients in remission of Crohn disease (wPCDAI or CDAI) | 2 years post-HSCT | Cumulative incidence of remission demonstrated by weighted Pediatric Crohn's Disease Activity Index (wPCDAI) \<12.5 or Crohn's Disease Activity Index (CDAI) of \<150 if adult |
| Secondary | Number of patients who achieve normal immune function derived from donor cells | 1 year post-HSCT | Cumulative incidence of patients with age-appropriate normalization of peripheral blood lymphocyte numbers including T, NK and B cells |
| Secondary | Number of patients who achieve full donor chimerism | 1 year post-HSCT | Cumulative incidence of patient chimerism defined as \>95% of donor cells as assessed by peripheral blood (total, CD15+, CD3+, CD56+, CD19+, and CD34+) chimerism by short tandem repeat (STR) or next generation sequencing (NGS) analysis |
| Secondary | Number of patients with healthy immune cell function | 1 year post-HSCT | Cumulative incidence of patients who have mitogen and antigen specific T-cell proliferation or cytokine release in response to in vitro stimulation |
| Secondary | Number of patients who regain CD3 cells | Day 90 and 180 post-HSCT | CD3 cell count of \>200/ uL |
| Secondary | Number of patients who experience moderate and severe chronic GvHD | 1 year post-HSCT | Cumulative incidence of patients experiencing moderate or severe chronic GvHD by NIH Consensus Criteria for Organ scoring of cGVHD |
| Secondary | Number of patients who experience severe infections | 1 year post-HSCT | Cumulative incidence of patients experiencing Grade 3 or higher CTCAE infections after HSCT |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 registered outcomesOutcomes0
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.
Papers13
The papers the trial lists on ClinicalTrials.gov.
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/NCT06986382
GET https://conductscience.org/api/trials/v1/NCT06986382/registered