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Phase 2 Study Evaluating Autologous CD30.CAR-T Cells in Adult and Pediatric Patients With Relapsed/Refractory HL

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04268706
Recruitment Status : Not yet recruiting
First Posted : February 13, 2020
Last Update Posted : February 13, 2020
Sponsor:
Information provided by (Responsible Party):
Tessa Therapeutics

Brief Summary:
This is a Phase 2 study to evaluate the safety and efficacy of autologous CD30.CAR-T in subjects with relapsed or refractory CD30+ classical Hodgkin Lymphoma.

Condition or disease Intervention/treatment Phase
Hodgkin Lymphoma, Adult Hodgkin Disease Recurrent Hodgkin Disease Refractory Hodgkin Disease, Pediatric Drug: CD30.CAR-T Phase 2

Detailed Description:

Subjects who meet eligibility criteria will have blood drawn to manufacture the CD30.CAR-T cells in a lab. CD30.CAR-T cells will be infused after the completion of lymphodepleting chemotherapy with fludarabine and cyclophosphamide.

Subjects will be monitored for safety and efficacy throughout the study. Subjects will be followed for survival, withdrawal of consent or study closure, whichever occurs first.

Health Related Quality of Life assessments will be collected for pediatric and adult patients during the study.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2 Multi-Center Study Evaluating the Safety and Efficacy of CD30-directed Genetically Modified Autologous T Cells (CD30.CAR-T) in Adult and Pediatric Patients With Relapsed or Refractory CD30 Positive Classical Hodgkin Lymphoma
Estimated Study Start Date : May 1, 2020
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : August 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: CD30 positive r/r classical Hodgkin Lymphoma

Patients with relapsed or refractory classical Hodgkin Lymphoma who have failed 3 prior lines of treatment, which may include a prior autologous and/or allogeneic stem cell transplant.

Patients will be treated with autologous CD30.CAR-T cells.

Drug: CD30.CAR-T
autologous CD30.CAR-T cells infused on Day 0 after the completion of lymphodepleting chemotherapy.




Primary Outcome Measures :
  1. To assess the anti-tumor effect of autologous CD30.CAR-T using objective response rate (ORR) as assessed by an Independent Radiology Review Committee (IRRC) per the Revised Criteria for Response Assessment: The Lugano Classification (Cheson, 2014) [ Time Frame: As early as 6 weeks after CD30.CAR-T treatment ]
    ORR


Secondary Outcome Measures :
  1. Number of patients with adverse events as a measure of safety and tolerability of CD30.CART cells [ Time Frame: Minimum 24 months post-CD30.CAR-T infusion ]
    Number of patients with treatment related adverse events as assessed by CTCAE v5.0

  2. Progression Free Survival (PFS) [ Time Frame: Minimum 24 months post-CD30.CAR-T infusion ]
    PFS

  3. Duration of Response (DOR) [ Time Frame: Minimum 24 months post-CD30.CAR-T infusion ]
    DOR

  4. Objective Response Rate as assessed by the Investigator [ Time Frame: Minimum 24 months post-CD30.CAR-T infusion ]
    ORR by Investigator

  5. Overall survival [ Time Frame: Minimum 24 months post-CD30.CAR-T infusion ]
    Survival

  6. Health Related quality of life (HRQoL) questionnaire [ Time Frame: Minimum 24 months post-CD30.CAR-T infusion ]
    QoL



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   12 Years to 75 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Eligibility is determined prior to blood collection . Patients must satisfy the following criteria to be enrolled in the study:

  1. Signed Informed Consent Form
  2. Male or female patients who are 12 - 75 years of age
  3. Histologically confirmed classical Hodgkin Lymphoma
  4. Relapsed or refractory cHL that has failed at least 3 prior lines of therapy, including:

    • chemotherapy
    • BV and/or
    • PD-1 inhibitor

    Patients may have previously received an autologous and/or allogeneic stem cell transplant

  5. CD30-positive tumor
  6. At least 1 measurable lesion according to The Lugano Classification
  7. ECOG PS of 0 to 1 or equivalent [either Karnofsky PS (for patients ≥ 16 year of age) or Lansky PS (for patients < 16 years of age)]
  8. Anticipated life expectancy > 12 weeks

Exclusion Criteria:

  1. CNS Hodgkin lymphoma or tumor infiltration of the meninges by brain MRI
  2. Inadequate laboratory abnormalities at screening:

    • Hgb < 8.0 g/dL
    • Total bilirubin > 1.5 × ULN
    • AST or ALT > 3 × the ULN
    • CrCl ≤ 45 mL/min
    • ANC <1,000/µL
    • Platelets <75,000/µL
    • PT or INR > 1.5 × ULN
  3. Active uncontrolled bleeding or a known bleeding diathesis, or patients that require on-going treatment with chronic, therapeutic dose of anti-coagulants.
  4. Inadequate pulmonary function defined as pulse oximetry < 90% on room air
  5. On-going treatment with chronic systemic glucocorticosteroids
  6. Anti-CD30 antibody-based therapy
  7. Prior CD30.CAR-T investigational product
  8. HIV positive
  9. Active hepatitis B and/or Hepatitis C infection

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04268706


Contacts
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Contact: Lotus Yung 832-390-2365 lotusyung@tessatherapeutics.com

Sponsors and Collaborators
Tessa Therapeutics
Investigators
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Principal Investigator: Helen Heslop, MD Baylor College of Medicine
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Responsible Party: Tessa Therapeutics
ClinicalTrials.gov Identifier: NCT04268706    
Other Study ID Numbers: TESSCAR001
First Posted: February 13, 2020    Key Record Dates
Last Update Posted: February 13, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Tessa Therapeutics:
r/r Hodgkin Lymphoma, CD30, adult, pediatrics
Additional relevant MeSH terms:
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Lymphoma
Hodgkin Disease
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases