Clinical trial • Not applicable • Oncology|Haematology

ALLOGENEIC CRISPR/CAS9-MEDIATED GENETICALLY MODIFIED CAR T CELLS TARGETING CD19 ANTIGEN for Solid malignancy|Hematologic malignancy

Not applicable trial of ALLOGENEIC CRISPR/CAS9-MEDIATED GENETICALLY MODIFIED CAR T CELLS TARGETING CD19 ANTIGEN for Solid malignancy|Hematologic malignanc…

Overview

Trial Therapeutic Area
Oncology|Haematology
Trial Disease
Solid malignancy|Hematologic malignancy
Trial Stage
Not applicable
Drug Modality
Cell therapy

Key dates

Initial CTIS Submission Date
12-03-2024
First CTIS Authorization Date
31-05-2024

Trial design

Not applicable trial across 1 site in Germany.

Target Sample Size
69
Trial Duration For Participant
5475

Eligibility

Recruits 69 isVulnerablePopulationSelected: false — No vulnerable population selected; no specific consent or assent handling described in the CTIS record..

Vulnerable Population
isVulnerablePopulationSelected: false — No vulnerable population selected; no specific consent or assent handling described in the CTIS record.

Inclusion criteria

  • {"criterion_text":"- Able to understand and comply with protocol-required study procedures and voluntarily sign and date a written informed consent document."}
  • {"criterion_text":"- Must have received CRISPR CAR cellular therapy."}

Exclusion criteria

  • {"criterion_text":"- There are no specific exclusion criteria."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Incidence of adverse events, including serious adverse events related to CRISPR CAR cellular therapy and adverse events of special interest","definition_or_measurement_approach":""}

Secondary endpoints

  • {"endpoint_text":"- Overall survival","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Duration of remission/response","definition_or_measurement_approach":""}

Recruitment

Planned Sample Size
69
Recruitment Window Months
182
Consent Approach
Written informed consent required; multiple Subject information and informed consent form documents are listed in the CTIS record (including general ICF, biobank ICF, pregnant participant ICF, pregnant partner ICF and 'tc' versions). No detailed age-specific assent procedures or languages are described in the CTIS metadata.

Geography

Total Number Of Sites
1
Total Number Of Participants
69

Germany

Earliest CTIS Part Ii Submission Date
21-05-2024
Latest Decision Or Authorization Date
17-10-2025
Processing Time Days
514
Number Of Sites
1
Number Of Participants
1

Sites

Site Name
University Medical Center Hamburg-Eppendorf
Department Name
Klinik für Stammzelltransplantation
Principal Investigator Name
Francis Ayuk
Principal Investigator Email
ayuketang@uke.de
Contact Person Name
Francis Ayuk
Contact Person Email
ayuketang@uke.de
Number Of Participants
1

Sponsor

Primary sponsor

Full Name
CRISPR Therapeutics AG
Organisation Type
Pharmaceutical company
Country Of Registered Address
Switzerland

Investigational products

Investigational Product Name
CTX110
Active Substance
ALLOGENEIC CRISPR/CAS9-MEDIATED GENETICALLY MODIFIED CAR T CELLS TARGETING CD19 ANTIGEN
Modality
Cell therapy
Routes Of Administration
INTRAVENOUS ADMINISTRATION
Route
INTRAVENOUS ADMINISTRATION
Authorisation Status
1
Maximum Dose
1 (unit: Other)

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