Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ongoing, recruitment ended
Participants planned
30
Countries
2
Sites
4
Kidney Transplant Rejection
To evaluate the long-term safety and tolerability of TX200-TR101 up to 15 years post-TX200-TR101 infusion/baseline.
Key facts
- Sponsor
- Sangamo Therapeutics Inc.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Phenomena and Processes [G] - Immune system processes [G12]
- Trial duration
- 21 Jul 2023 → ongoing
- Decision date (initial)
- 2024-07-31
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
- Funding sources
- Sangamo Therapeutics Inc.
External identifiers
- EU CT number
- 2024-512580-31-00
- EudraCT number
- 2022-002440-40
- WHO UTN
- U1111-1307-4332
- ClinicalTrials.gov
- NCT05987527
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety
To evaluate the long-term safety and tolerability of TX200-TR101 up to 15 years post-TX200-TR101 infusion/baseline.
Secondary objectives 1
- To evaluate the effect of TX200-TR101 on long-term graft-related outcomes up to 15 years post-TX200-TR101 infusion/baseline.
Conditions and MedDRA coding
Kidney Transplant Rejection
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | LLT | 10050436 | Prophylaxis against renal transplant rejection | 10042613 |
Regulatory references
- Plan to share IPD
- No
- IPD plan description
- Undecided
| EU CT number | Title | Sponsor |
|---|---|---|
| 2024-512579-11-00 | A Multicentre, Open-Label, Single Ascending Dose, Dose-Ranging, Phase I/IIa Study to Evaluate the Safety and Tolerability of an Autologous Antigen-Specific Chimeric Antigen Receptor T Regulatory Cell Therapy (TX200-TR101) in Living Donor Renal Transplant Recipients | Sangamo Therapeutics France |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 2
- 1. Subjects who enrolled in the Phase I/IIa study TX200-KT02, received a transplanted kidney and have either completed or withdrawn from that study.
- 1. Willing and able to provide written informed consent (IC) in accordance with local regulations and governing Independent Ethics Committee (IEC)/Institutional Review Board (IRB) requirements prior to any procedure or evaluation performed specifically for the sole purpose of the study.
Exclusion criteria 1
- No Exclusion criteria for this study
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 2
- Overall survival
- Indicence and grade of Serious Adverse Events
Secondary endpoints 3
- Incidence of immune-mediated rejection in terms of BCAR episodes according to the Banff criteria (including type, severity and timing)
- Incidence of graft loss due to rejection
- Incidence and severity of chronic graft dysfunction, as measured by eGFR
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
PRD8589690 · Product
- Active substance
- TX200-TR101
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 00 Other
- Max total dose
- 00 Other
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Not Authorised
- MA holder
- SANGAMO THERAPEUTICS FRANCE SAS
- Paediatric formulation
- No
- Orphan designation
- Yes
- Orphan designation number
- EMA/OD/0000078610
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Sangamo Therapeutics Inc.
- Sponsor organisation
- Sangamo Therapeutics Inc.
- Address
- 501 Canal Boulevard Suite A100
- City
- Richmond
- Postcode
- 94804-3522
- Country
- United States
Scientific contact point
- Organisation
- Sangamo Therapeutics Inc.
- Contact name
- Sangomo Patient Advocacy
Public contact point
- Organisation
- Sangamo Therapeutics Inc.
- Contact name
- Sangomo Patient Advocacy
Third parties 6
| Organisation | City, country | Duties |
|---|---|---|
| IDEA Innovative Drug European Associates (Ireland) Limited ORG-100013690
|
Dublin 14, Ireland | Other |
| Scout Clinical ORG-100042228
|
Dallas, United States | Other |
| Qualitymetric Incorporated LLC ORG-100044132
|
Johnston, United States | Other |
| Medidata Solutions Inc. ORG-100016256
|
New York, United States | Data management |
| Medpace Inc. ORG-100026760
|
Cincinnati, United States | Code 5 |
| Q-Square Business Intelligence Corp. ORG-100046191
|
Boxborough, United States | Code 10 |
Locations
2 EU/EEA countries · 4 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ongoing, recruitment ended | 10 | 1 |
| Netherlands | Ongoing, recruitment ended | 10 | 3 |
| Rest of world
United Kingdom
|
— | 10 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Belgium | 2023-12-20 | 2024-02-13 | 2025-10-16 | ||
| Netherlands | 2023-07-21 | 2023-08-15 | 2025-10-16 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 27 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol_2024-512580-31_Sangamo Therapeutics_redacted | 3.0 |
| Protocol (for publication) | D4_Patient facing documents_SF-36_DU-BE_Sangamo_blank | N/A |
| Protocol (for publication) | D4_Patient facing documents_SF-36_DU-NL_Sangamo_blank | N/A |
| Protocol (for publication) | D4_Patient facing documents_SF-36_EN_Sangamo_blank | N/A |
| Protocol (for publication) | D4_Patient facing documents_SF-36_FR_Sangamo_blank | N/A |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_BE_Sangamo | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_NL_Sangamo | 1.1 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_ Rollover FAQ_DU_Sangamo | 2 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_ Rollover FAQ_EN_Sangamo | 2 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_ Rollover FAQ_FR_Sangamo | 2 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Rollover FAQ_Sangamo | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Control_DU_Sangamo_redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Control_EN_Sangamo_redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Control_FR_Sangamo_redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Control_Sangamo | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_Sangamo_redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnancy_DU_Sangamo_redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnancy_EN_Sangamo_redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnancy_FR_Sangamo_redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnancy_Sangamo | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Recipients_DU_Sangamo_redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Recipients_EN_Sangamo_redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Recipients_FR_Sangamo_redacted | 3.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_DE_2024-512580-31-00_Sangamo | 3.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_DU_2024-512580-31-00_Sangamo | 3.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_EN_2024-512580-31-00_Sangamo | 3.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_FR_2024-512580-31-00_Sangamo | 3.0 |
Application history
4 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-07-08 | Belgium | Acceptable with conditions 2024-07-30
|
2024-07-31 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-02-14 | Belgium | Acceptable 2025-02-20
|
2025-02-20 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-03-10 | Belgium | Acceptable 2025-06-06
|
2025-06-06 |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2026-03-02 | Belgium | Acceptable 2025-06-06
|
2026-03-02 |