None listed
Conditions
Interventions
Intervention1: Nil: Nil
Sponsors
Micro CRISPR Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: Subject is eligible to provide one unit of blood as per criteria for blood donation as per applicable blood bank procedures. Willing and able to provide written informed consent for the study.
Exclusion criteria
Exclusion criteria: If donor has been found positive for any Transfusion transmitted diseases following testing. If buffy coat and plasma could not be prepared/separated due to procedural/technical reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To understand and validate different manufacturing protocols, assay designs, and molecular designs of CAR-T, CAR-NK , and other CGT products, as well as their armouring modules to provide for better efficacy, durable persistence and safety.Timepoint: Not Applicable as its Validation study | — |
Secondary
| Measure | Time frame |
|---|---|
| To understand safety & functional potency of CGT products, as measured in in vitro or in vivo studies. To understand the efficacy, safety & persistence of the CGT products using spheroid, organoid, & tumoroid models. Any other parameters as deemed appropriate during scientific evaluations. Optimization of unit operations of manufacturing process as a part of process development. To conduct the process performance qualification. Timepoint: Not Applicable as its Validation study | — |
Countries
India
Contacts
Public ContactMukesh Kumar Saroj
Micro CRISPR Pvt. Ltd.
Outcome results
None listed