Pipeline

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

Learn About Data Presented at ASH’22

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

• 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

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