Pipeline

Product Indication Preclinical Phase 1 Phase 2 / 3*
Late Stage Pipeline

TT11

CD30-CAR Ts
Classical Hodgkin Lymphoma**
CD30+ Non-Hodgkin Lymphoma
Allogeneic Platform

TT11X***

Allogeneic CD30-CAR EBVSTs
CD30+ Lymphoma
Solid Tumor Targeting

TT16***

HER2-CAR-Ts + CAdVEC
HER2+ Cancer

* Pivotal
** RMAT and PRIME Designations by FDA & EMA
*** Investigator-sponsored Studies (Baylor College of Medicine), funded by Tessa

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 (Not Yet Recruiting)
Learn more at Clinicaltrials.gov

Exploratory Objectives: Expansion and persistence of autologous CD30 CAR-T in blood, Immunogenicity against anti-CD30 scFV in blood following CD30 CAR-T infusion, Cytokine profiling in blood, Immunological parameters in blood, Tumor markers in blood and tumor tissue, ctDNA in blood

*Fludarabine (Flu): 30mg/m2/day
Bendamustine (Benda): 70mg/m2/day

TT11 Phase 1 CERTAIN Study: Autologous CD30 CAR-T in Relapsed / Refractory CD30 Positive Non-Hodgkin Lymphoma

Primary Objectives

  • Safety and dose-limiting toxicities

Secondary Objectives

  • Pharmacokinetics
  • Objective response rate
  • Duration of response
  • Progression free survival

Treatment

  • Dose escalation: 2, 4, and 10 x 108 CD30 CAR-T cells/m2

Lymphodepletion

  • Flu / Benda* for 3 days

Key Eligibility Criteria

  • 18 – 75 years of age
  • Histologically confirmed ALCL, PTCL-NOS, ENKTCL nasal type, DLBCL-NOS and PMBCL
  • Relapsed / refractory CD30 positive NHL who have failed all available standards of therapy. Patients may or may not have received an autologous or allogeneic HSCT
  • CD30 positive tumor
  • ECOG 0 to 1 or equivalent

ClinicalTrials.gov Identifier: NCT04526834 (Recruiting)
Learn more at Clinicaltrials.gov

Exploratory Objectives: Immunogenicity against murine anti-CD30 scFv following CD30 CAR-T infusion in blood, Cytokine profiling in blood, Immunological parameters in blood, Tumor markers in blood and tumor tissue, ctDNA in blood, Overall survival

*Fludarabine (Flu): 30mg/m2/day
Bendamustine (Benda): 70mg/m2/day

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

Exploratory Objectives: Expansion and persistence of allogeneic CD30 CAR EBVSTs in blood, Association between immunological parameters in blood, safety, and clinical response

*Cyclophosphamide (Cy): 500mg/m2/day
Fludarabine (Flu): 30mg/m2/day

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

Exploratory Objectives: Immunogenicity by determining impact of treatment on cellular and humoral immunity in the blood and tumor tissue, Long-term persistence and functional status of HER2 CAR-T cells in blood, Measure levels of adenovirus antibodies during the trial, and correlate to clinical and immunological findings

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 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.

View Abstract

 

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

View Abstract

 

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.

View Abstract

 

August 2017

Clinical and immunological responses after CD30-specific chimeric antigen receptor–redirected lymphocytes

J Clin Invest. 2017; 127(9):3462-3471.

View Article

 

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

View Article

 

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.

View Article