Overview
Sponsor-declared trial summary
Solid Malignancy
To evaluate the long-term safety of CRISPR CAR cellular therapy treatment of hematological and solid malignancies
Key facts
- Sponsor
- CRISPR Therapeutics AG
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04], Diseases [C] - Hemic and Lymphatic Diseases [C15]
- Trial duration
- 26 Jul 2024 → ongoing
- Decision date (initial)
- 2024-05-31
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-512479-11-00
- ClinicalTrials.gov
- NCT06208878
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy, Safety
To evaluate the long-term safety of CRISPR CAR cellular therapy treatment of hematological and solid malignancies
Secondary objectives 1
- To evaluate the long-term efficacy of CRISPR CAR cellular therapy for treatment of hematological and solid malignancies
Conditions and MedDRA coding
Solid Malignancy
Regulatory references
- Plan to share IPD
- No
| EU CT number | Title | Sponsor |
|---|---|---|
| 2018-003916-38 | A Phase 1/2 Dose Escalation and Cohort Expansion Study of the Safety and Efficacy of Allogeneic CRISPR-Cas9–Engineered T Cells (CTX110) in Subjects with Relapsed or Refractory B-Cell Malignancies, Estudio de fase I de aumento gradual de la dosis y ampliación de cohortes sobre la seguridad y la eficacia de linfocitos T anti-CD19 alogénicos genomodificados mediante CRISPR-Cas9 (CTX110) en pacientes con neoplasias malignas de linfocitos B recidivantes o resistentes al tratamiento., Étude de phase I d’escalade de dose et d’extension de cohorte portant sur l’innocuité et l’efficacité des lymphocytes T allogéniques anti-CD19 modifiés par CRISPR-Cas9 (CTX110) chez des patients atteints de pathologie maligne des lymphocytes B en rechute ou réfractaire |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 2
- Able to understand and comply with protocol-required study procedures and voluntarily sign and date a written informed consent document.
- Must have received CRISPR CAR cellular therapy.
Exclusion criteria 1
- There are no specific exclusion criteria.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Incidence of adverse events, including serious adverse events related to CRISPR CAR cellular therapy and adverse events of special interest
Secondary endpoints 2
- Overall survival
- Duration of remission/response
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Allogeneic CRISPRCAS9-MEDIATED Genetically Modified Car T Cells Targeting CD19 Antigen
PRD7256009 · Product
- Active substance
- Allogeneic CRISPRCAS9-MEDIATED Genetically Modified Car T Cells Targeting CD19 Antigen
- Pharmaceutical form
- DISPERSION FOR INFUSION
- Route of administration
- INTRAVENOUS ADMINISTRATION
- Max daily dose
- 1 Other
- Max total dose
- 1 Other
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Not Authorised
- MA holder
- CRISPR THERAPEUTICS AG
- Paediatric formulation
- No
- Orphan designation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
CRISPR Therapeutics AG
- Sponsor organisation
- CRISPR Therapeutics AG
- Address
- Baarerstrasse 14
- City
- Zug
- Postcode
- 6300
- Country
- Switzerland
Scientific contact point
- Organisation
- CRISPR Therapeutics AG
- Contact name
- Samarth Kulkarni
Public contact point
- Organisation
- CRISPR Therapeutics AG
- Contact name
- Samarth Kulkarni
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Germany | Ongoing, recruiting | 1 | 1 |
| Rest of world
Australia, Canada, United States
|
— | 69 | — |
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 |
|---|---|---|---|---|---|
| Germany | 2024-07-26 | 2024-07-30 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 11 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Recruitment arrangements (for publication) | CRSP-ONC-LTF Recruitment | 1 |
| Subject information and informed consent form (for publication) | CRSP-ONC-LTF Study Questionnaire | 1 |
| Subject information and informed consent form (for publication) | ICF_Biobank_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | ICF_Biobank_tc_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | ICF_Pregnant_Redacted | 1 |
| Subject information and informed consent form (for publication) | ICF_PregnantParticipant_Redacted | 1.2 |
| Subject information and informed consent form (for publication) | ICF_PregnantParticipant_tc_Redacted | 1.2 |
| Subject information and informed consent form (for publication) | ICF_PregnantPartner_Redacted | 1.2 |
| Subject information and informed consent form (for publication) | ICF_PregnantPartner_tc_Redacted | 1.2 |
| Subject information and informed consent form (for publication) | ICF_Redacted | 3.2 |
| Subject information and informed consent form (for publication) | ICF_tc_Redacted | 3.2 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-03-12 | Germany | Acceptable 2024-05-31
|
2024-05-31 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-10-01 | Germany | Acceptable | 2024-12-03 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-09-11 | Germany | Acceptable | 2025-10-17 |