Ignite Creation Date:
2025-12-25 @ 2:11 AM
Ignite Modification Date:
2025-12-26 @ 12:39 AM
Study NCT ID:
NCT06393660
Status:
AVAILABLE
Last Update Posted:
2025-10-14
First Post:
2024-04-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Treatment Use of the CliniMACS® CD34 TCR Alpha/Beta for Allogenic Transplant (Expanded Access Use)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'EXPANDED_ACCESS'}, 'statusModule': {'overallStatus': 'AVAILABLE', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'lastUpdateSubmitDate': '2025-10-11', 'studyFirstSubmitDate': '2024-04-09', 'studyFirstSubmitQcDate': '2024-04-26', 'lastUpdatePostDateStruct': {'date': '2025-10-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-05-01', 'type': 'ACTUAL'}}, 'conditionsModule': {'keywords': ['TCR Alpha/Beta', 'CliniMACS'], 'conditions': ['Transplant-Related Disorder', 'GVH - Graft Versus Host Reaction']}, 'descriptionModule': {'briefSummary': 'The protocol is designed to provide access to patients to the Clinimacs® CD34 TCRαβ system to prepare cells for an unlabeled indication using an HLA-compatible related or unrelated donor for allogenic transplant.', 'detailedDescription': 'Allogeneic hematopoietic stem cell transplant (HSCT) is the only known curative therapy for a variety of non-malignant and malignant disorders1-4. Only about 25% of patients have an HLA-matched sibling and in about 16-75% (depending on ethnicity), a 10/10 HLA-matched unrelated donor can be identified. Engraftment failure is a dynamic complex process that may occur with this product due to unbalanced depletion of T-cells between recipient and donor, not only due to low number of CD34 cells. The use of mis-matched or haploidentical donors is associated with a higher risk of post-transplant mortality due to the development of severe graft versus host disease, graft failure and the development of infection due to the use of immunosuppression or T cell depletion. A total of 10 patients will be enrolled. The patients will be divided into 2 strata (haploidentical 7, unrelated donor 3).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Recipient Inclusion Criteria:\n\n* Age less than 22 years of age\n* No available genotypically matched related donor (sibling)\n* Availability of a suitable donor and graft source\n* Haploidentical related mobilized peripheral blood cells\n* 9/10 or 10/10 allele matched (HLA-A, -B, -C, -DRB1, -DQB1) volunteer unrelated donor mobilized peripheral blood cells\n\nDonor Inclusion Criteria:\n\n* Matching as described in the Recipient and Donor Suitability Criteria\n* Size and vascular access appropriate by center standard for peripheral blood stem cell (PBSC) collection. Donors with inadequate peripheral access will require placement of an apheresis catheter for collection.\n* Must meet appropriate screening/eligibility requirements:\n\n * Haploidentical matched family members: screened by center health screens and found to be eligible.\n * Unrelated donors: meet suitability criteria to donate PBSC\n * HIV negative\n * Not pregnant or lactating\n * Recipient must not have high-level donor specific anti-HLA antibodies according to institutional practices.\n * Must agree to donate PBSC\n * Must give informed consent\n\nRecipient Suitability:\n\n\\- Adequate organ functioning as demonstrated by:\n\n* MUGA ≥ 50% or ECHO \\>30%\n* 24-hour Creatinine Clearance or Glofil ≥ 50 ml/min or Serum Creatinine ≤2 times the upper limit of normal\n* DLCO \\> 65% of predicted value. FEV1 \\>65% of predicted\n* AST / ALT ≤ 2.5 and/or Bilirubin ≤ 1.5 times the upper limit of normal\n* Pregnancy test negative\n* HIV 1 / 2 (HIV screen) negative with a negative qualitative HIV PCR.\n* HTLV I negative\n* RPR or VDRL negative\n* RVP (Respiratory Viral PCR) with a negative result\n* Positive hepatitis testing does not make the patient ineligible. Hepatitis results will be evaluated on a case-by-case basis by the transplant physician to determine donor suitability/eligibility.\n\nDonor Suitability:\n\n\\- Allowed Donor Sources\n\n* Fully matched sibling donors are not allowed.\n* Unrelated donors. HLA typing of at least 10 alleles is required. Donor must be matched at 9/10 or 10/10 alleles (HLA-A, -B, -C, -DRB1, -DQB1). Haploidentical matched family members. Minimum match level full haploidentical (at least 5/10; HLA-A, -B, -C, -DRB1, -DQB1 alleles), but use of haploidentical donors with extra matches (e.g., 6, 7, or 8/10) encouraged.\n* Cord blood is not allowed as a stem cell source on this IDE.\n\nRecipient and Donor Exclusion Criteria:\n\n* Pregnant or lactating females are ineligible as the risk to unborn children and infants is unknown\n* Presence of life-threatening, uncontrolled opportunistic infection (fungal, bacterial, or viral infections). Patients with history of fungal disease during induction therapy may proceed if they have a significant response to antifungal therapy with no or minimal evidence of disease remaining by CT evaluation.\n* HIV or HTLV I/II infection'}, 'identificationModule': {'nctId': 'NCT06393660', 'briefTitle': 'Treatment Use of the CliniMACS® CD34 TCR Alpha/Beta for Allogenic Transplant (Expanded Access Use)', 'organization': {'class': 'OTHER', 'fullName': 'University of Texas Southwestern Medical Center'}, 'officialTitle': 'Treatment Use of the CliniMACS® CD34 TCR Alpha/Beta to Prepare Cells for an Unlabeled Indication Using an HLA-Compatible Related or Unrelated Donor for Allogenic Transplant', 'orgStudyIdInfo': {'id': 'STU-2024-0185'}}, 'armsInterventionsModule': {'interventions': [{'name': 'CliniMACS® CD34 TCR Alpha/Beta', 'type': 'DEVICE', 'description': 'CliniMACS System uses an automated antibody/magnetic beads column system that allows efficient depletion of TCRαβ and CD19+ cells without relevant loss of cell viability. Hematopoietic stem cells are retained in sufficient numbers to permit engraftment and hematopoietic reconstitution. Humanitarian Exemption IDE approval has been obtained for CD34+ cell selection as a method of T-cell depletion.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '75235', 'city': 'Dallas', 'state': 'Texas', 'status': 'AVAILABLE', 'country': 'United States', 'contacts': [{'name': 'Victor Aquino, MD', 'role': 'CONTACT', 'email': 'Victor.Aquino@utsouthwestern.edu', 'phone': '214-456-2382'}], 'facility': "Children's Medical Center - Dallas", 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}], 'centralContacts': [{'name': 'Victor Aquino, MD', 'role': 'CONTACT', 'email': 'Victor.Aquino@utsouthwestern.edu', 'phone': '214-648-3896'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Victor Aquino', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Victor Aquino', 'investigatorAffiliation': 'University of Texas Southwestern Medical Center'}}}}