Pipeline
* Investigator-sponsored Studies (Baylor College of Medicine), funded by Tessa
** Covered under a Cooperative Research and Development Agreement with the U.S. National Cancer Institute
TT11X Phase 1 BESTA Study: Allogeneic CD30 CAR EBVST in Relapsed / Refractory CD30 Positive Lymphoma

Primary Objectives
- Safety and dose limiting toxicities
Secondary Objectives
- Objective response rate
- Duration of response
- Stable disease rate
- Duration of stable disease
- Progression free survival
Key Eligibility Criteria
- 1 of the following diagnoses: Hodgkin Lymphoma, aggressive non-Hodgkin Lymphoma, ALK-negative anaplastic T-cell Lymphoma or other peripheral T-cell Lymphoma, ALK-positive anaplastic T-cell Lymphoma
- CD30 positive tumor
- 12 – 75 years of age
- Karnofsky or Lansky score of > 60%
Treatment
- Dose escalation: 4 x 107, 1 x 108, 4 x 108 CD30 CAR EBVST cells/m2
Lymphodepletion
- Cy / Flu for 3 days
Sponsor:
Baylor College of Medicine (Funded by Tessa)
ClinicalTrials.gov Identifier: NCT04288726 (Recruiting)
Learn more at Clinicaltrials.gov
TT16 Phase 1 VISTA Study: HER2 CAR-Ts + Binary Oncolytic Adenovirus in HER2 Positive Solid Tumors

Primary Objectives
- Dose limiting toxicities
Secondary Objectives
- Overall response rate
- Disease control rate
- Progression free survival
- Overall survival
- Number of grade ≥ 3 treatment related adverse events
Key Eligibility Criteria
- Histologically confirmed HER2 positive solid tumors
- Deemed unsuitable for curative surgery, radiotherapy, systemic therapy, including checkpoint inhibitors, or any combination of the above modalities
- Disease must have progressed after standard first line therapy, or without available effective treatment options. Patients are still eligible if they have failed more than one line of therapy
- ECOG 2 or less
- Aged 18 and above
Treatment
- DL1: 5 x 109 Oncolytic Adenovirus cells
- DL2: 10 x 1010 Oncolytic Adenovirus cells
- DL3: 10 x 1010 Oncolytic Adenovirus cells + 10 x 106 HER2 CAR-T cells
- DL4: 10 x 1011 Oncolytic Adenovirus cells + 10 x 106 HER2 CAR-T cells
- DL5: 10 x 1011 Oncolytic Adenovirus cells + 10 x 107 HER2 CAR-T cells
- DL6: 10 x 1012 Oncolytic Adenovirus cells + 10 x 107 HER2 CAR-T cells
- DL7: 10 x 1012 Oncolytic Adenovirus cells + 10 x 108 HER2 CAR-T cells
Sponsor:
Baylor College of Medicine (Funded by Tessa)
ClinicalTrials.gov Identifier: NCT03740256 (Recruiting)
Learn more at Clinicaltrials.gov
TT11 Phase 2 CHARIOT Study: Autologous CD30 CAR-T in Relapsed / Refractory CD30 Positive Classical Hodgkin Lymphoma

Primary Objectives
- Objective response rate (by Independent Committee)
Secondary Objectives
- Safety
- Progression free survival
- Duration of response
- Objective response rate (by Investigator)
- Overall survival
- Quality of Life
Treatment
- 2 x 108 CD30 CAR-T cells/m2
Lymphodepletion
- Flu / Benda for 3 days
Key Eligibility Criteria
- 12 – 75 years of age
- Histologically confirmed cHL
- Relapsed / refractory cHL that has failed at least 3 prior lines of therapy, including chemotherapy, brentuximab vedotin and PD-1 inihibitor. Patients may have previously received an autologous and / or allogeneic stem cell transplant
- CD30 positive tumor
- ECOG 0 to 1 or equivalent
ClinicalTrials.gov Identifier: NCT04268706 (Study paused until co-development partner identification)
Learn more at Clinicaltrials.gov

References:
– Tessa Therapeutics Announces Results from Two Independent Phase 1/2 Trials of Autologous CD30 CAR-T Cell Therapy in Patients with Relapsed or Refractory Hodgkin Lymphoma
– Tessa Therapeutics Announces Positive Data from Phase 2 Trial of Autologous CD30-CAR-T Therapy (TT11) in Relapsed or Refractory Classical Hodgkin Lymphoma at 2021 ASH Annual Meeting
TT11 Phase 1B/2 ACTION Study: Autologous CD30 CAR-T w/ Nivolumab – 2nd Line CD30 Positive Classical Hodgkin Lymphoma
Primary Objectives
- Safety of autologous CD30.CAR-T in combination with nivolumab
Secondary Objectives
- Anti-tumor activity using CR rate of autologous CD30.CAR-T in combination with nivolumab
- Overall response rate ORR
- Duration of response
- Progression-free survival
- Overall survival
- Pharmacokinetics – Maximum concentration – Maximum concentration of CD30.CAR-T
- Pharmacokinetics – Time of maximum concentration (Tmax) CD30.CAR-T
- Pharmacokinetics – Area under the curve CD30.CAR-T
Key Eligibility Criteria
- Patients with relapsed or refractory cHL after frontline therapy
- Age: 12 years and above
- CD30 –positive biopsy
- ECOG Performance status of 0 or 1
- 1 measurable lesion (FDG-avid and measurable)
- No active autoimmune disease
Study Treatment:
- Nivolumab: 2 cycles @ 4-week intervals
- Lymphocyte depleting treatment
- Fludarabine 30mg/m2/day
- Bendamustine 70mg/m2/day
- CD30.CAR-T
- Target 2 X108 cells/m2
- Nivolumab: 2 cycles @ 4-week intervals
ClinicalTrials.gov Identifier: NCT05352828 (Recruiting, Proof of Concept Study)
Learn more at Clinicaltrials.gov
Expanded Access
Tessa Therapeutics is dedicated to the development of next-generation cell therapies for a variety of hematologic malignancies and solid tumors.
At this stage of our drug development program for investigational product CD30-directed genetically modified autologous T cells (CD30.CAR-T), we are evaluating the safety and efficacy of our proprietary process of isolating human T cells from peripheral blood mononuclear cells for infusion into patients with resistant Hodgkin lymphoma. This research is being conducted through clinical trials that—with continued success—may provide the basis for a submission to the U.S. Food and Drug Administration (FDA) for drug approval.
To learn more about our clinical trials, including eligibility requirements for participating in ongoing studies, please visit ClinicalTrials.gov, a U.S. government-run database listing private and publicly funded clinical studies conducted around the world.
As part of the drug development process, the FDA allows for Expanded Access or Compassionate Use of investigational drugs prior to regulatory approval. At this time, Tessa Therapeutics does not have a compassionate use program. As cell therapy is a specialized process, we prefer that Hodgkin lymphoma patients consult with a nearest clinical site—since these physicians and facilities are most able to deliver the complex treatment and monitoring required.
For any additional questions, please contact us at clinicaltrials@tessacell.com.
Scientific Publications
December 2021
Safety and Efficacy Profile of Autologous CD30.CAR-T-Cell Therapy in Patients with Relapsed or Refractory Classical Hodgkin Lymphoma (CHARIOT Trial)
Presented at AS 2021
December 2021
Safety and Efficacy of Off-the-Shelf CD30.CAR-Modified Epstein-Barr Virus-Specific T Cells in Patients with CD30-Positive Lymphoma
Presented at AS 2021
December 2020
3268 A Bank of CD30.CAR-Modified, Epstein-Barr Virus-Specific T Cells That Lacks Host Reactivity and Resists Graft Rejection for Patients with CD30-Positive Lymphoma (Abstract)
Presented at ASH 2020.
September 2020
Steering Chimeric Antigen Receptor T Cells Into the Hodgkin Lymphoma Niche (Editorial)
Journal of Clinical Oncology 38, no. 32 (November 10, 2020) 3816-3818
July 2020
Anti-CD30 CAR-T Cell Therapy in Relapsed and Refractory Hodgkin Lymphoma
Journal of Clinical Oncology 38, no. 32 (November 10, 2020) 3794-3804.
August 2017
Clinical and immunological responses after CD30-specific chimeric antigen receptor–redirected lymphocytes
J Clin Invest. 2017; 127(9):3462-3471.
April 2017
Armed Oncolytic Adenovirus–Expressing PD-L1 Mini-Body Enhances Antitumor Effects of Chimeric Antigen Receptor T Cells in Solid Tumors
Cancer Res; 77(8); 2040–51
May 2007
Epstein Barr virus–specific cytotoxic T lymphocytes expressing the anti-CD30ζ artificial chimeric T-cell receptor for immunotherapy of Hodgkin disease
Blood. 2007 Oct 1; 110(7): 2620–2630.