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T-cell Immunotherapy: Clinical Trial Tracker

T-cell Immunotherapy: Clinical Trial Tracker

  • July 2016
  • ID: 4006952
  • Format: PDF
  • Roots Analysis Private Ltd.

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INTRODUCTION
After years of research tracing back to the 18th century, a gamut of novel therapies namely, CAR-T, TCR and TIL therapies, have finally reached a point of maturity. These promising therapeutic strategies, developed under the banner of T-cell immunotherapies, are set to hit the market in the near future. T-cells, also named as the soldiers of the immune system, are featured with specificity and functionally combat infections, cancerous cells and other foreign entities. High therapeutic potential and favorable clinical outcomes outweigh the challenges such as high cost, tedious manufacturing and ethical concerns serving as the roadblocks to the progress of the therapy.

With no marketed products, this emerging field is still in its infancy. Research institutions, through investment of time, expertise and effort, have played a critical role in maturing the design and development of novel CAR-Ts, TCRs and TILs. Post the initial research, industry players have collaborated with non-industry participants to fund the clinical and commercial development of these products. Some late stage products that have emerged out of such collaborations include CTL-019 (Novartis/University of Pennsylvania/The Children’s Hospital of Philadelphia), JCAR017 (Juno Therapeutics/Seattle Children’s Hospital), KTE-C19 and HPV-16 E6 TCR (Kite Pharma/National Cancer Institute), CD19-CAR (Takara Bio / Jichi Medical University) and LN-144 (Lion Biotechnologies/National Cancer Institute).

SCOPE OF THE REPORT
The primary objective of this report is to capture details on the various clinical trials that are currently underway in the field of T-cell Immunotherapy. We have identified a number of T-cell Immunotherapy products and clinical trials that are either being conducted or planned to be conducted for each of these products. For each specific product, we have provided the following information:
1. Primary Drug
2. Highest Phase of Development
3. Developer/Licensee
4. Target Antigen

For each specific trial, we have provided the following information:
1. Indication
2. Type of Indication
3. Sponsor/Collaborator
4. Type of Sponsor
5. Trial Title
6. Trial Objective
7. Trial Phase
8. Trial Status
9. Start Date
10. End Date
11. Enrolment
12. Age Range
13. Inclusion Criteria
14. Exclusion Criteria
15. Study Design
16. Primary Endpoint
17. Secondary Endpoint
18. Treatment Arm(s)
19. Location(s)
20. Trial Results (if known)

The above information has also been presented in the form a dashboard to provide a high level quick overview of the ongoing activity in this space.

In addition to the clinical trial details, the report also provides the following:
- Sales forecasts of the T-cell Immunotherapy market over the course of next fifteen years. Owing to the emerging nature of this market, we have presented three scenarios to add robustness to our market forecast. The conservative, base and optimistic scenarios represent three different tracks of industry evolution.

RESEARCH METHODOLOGY
The data presented in this report has been gathered via secondary research. The secondary sources of information include
- Clinical trial registries
o Clinicaltrials.gov
o International Clinical Trials Registry Platform (ICTRP)
o EU Clinical Trials Register (EU CTR)
o Chinese Clinical Trial Register (ChiCTR)
- Annual reports
- Investor presentations
- SEC filings
- Company websites
- Conference websites
- Industry analysts’ views

The focus has been on capturing the details on completed and ongoing clinical trials for T-cell immunotherapy. The report also provides an in-depth analysis of the competitive landscape for both pipeline molecules and clinical trials. The analysis is solely based on our knowledge and research gathered from various secondary sources of information.

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