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Phase 1 Study of Autologous CD30.CAR-T in Relapsed or Refractory CD30 Positive Non-Hodgkin Lymphoma (CERTAIN)

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ClinicalTrials.gov Identifier: NCT04526834
Recruitment Status : Recruiting
First Posted : August 26, 2020
Last Update Posted : February 12, 2021
Sponsor:
Information provided by (Responsible Party):
Tessa Therapeutics

Study Description
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Brief Summary:
This is a phase 1 study to evaluate safety and dose-limiting toxicity of autologous CD30.CAR-T in subjects with relapsed or refractory CD30+ Non-Hodgkin Lymphoma

Condition or disease Intervention/treatment Phase
Anaplastic Large Cell Lymphoma Peripheral T Cell Lymphoma Extranodal NK/T-cell Lymphoma Diffuse Large B Cell Lymphoma Primary Mediastinal Large B-Cell Lymphoma (PMBCL) Drug: CD30.CAR-T Phase 1

Detailed Description:

Adult patients with relapsed or refractory CD30-positive Non-Hodgkin Lymphoma who have failed standard available therapies and who meet eligibility criteria will have blood drawn to manufacture the CD30.CAR-T cells.

CD30.CAR-T cells will be infused once following the completion of lymphodepleting chemotherapy with Bendamustine and Fludarabine.

Subjects will be closely monitored for DLT and safety.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 21 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 1 Study of CD30-Directed Genetically Modified Autologous T-Cells (CD30.CAR-T) in Patients With Relapsed or Refractory CD30 Positive Non-Hodgkin Lymphoma
Actual Study Start Date : November 20, 2020
Estimated Primary Completion Date : February 2022
Estimated Study Completion Date : February 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arms and Interventions
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Arm Intervention/treatment
Experimental: CD30 positive NHL subtypes

(ALCL, PTCL-NOS, ENKTCL, DLBCL-NOS, PMBCL)

Dose Level 1

Dose Level 2

Dose Level 3

 Drug: CD30.CAR-T

Bendamustine and Fludarabine (3 days)

Dose level 1: 2 x 108 cell/m2 CD30.CAR-T (Day 0)

Dose level 2: 4 x 108 cell/m2 CD30.CAR-T (Day 0)

Dose level 3: 6 x 108 cell/m2 CD30.CAR-T (Day 0)

Other Name: CD30-directed genetically modified autologous T cells


Outcome Measures
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Primary Outcome Measures :
  1. To evaluate safety and dose limiting toxicities (DLT) of autologous CD30.CAR-T and establish the recommended Phase dose [ Time Frame: Day 0 to 28 for DLT ]
    Incidence of DLTs and occurrence of study related adverse events


Secondary Outcome Measures :
  1. To evaluate pharmacokinetics of autologous CD30.CAR-T [ Time Frame: Start of infusion of CD30.CAR-T (Day 0) until year 5 ]
    AUC (copies/ug DNA over time)

  2. Objective Response Rate (ORR) [ Time Frame: Start of CD30.CAR-T (Day 0) until progressive disease or start of new cancer therapy, whichever comes first, up to one year ]
    ORR

  3. Duration of Response (DOR) [ Time Frame: Start of CD30.CAR-T (day 0) until progressive disease or death, whichever comes first, up to one year ]
    DOR

  4. Progression Free Survival (PFS) [ Time Frame: Start of CD30.CAR-T (Day 0) until progressive disease or death, whichever comes first, up to one year ]
    PFS


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Eligibility is determined priori to leukapheresis. Patients must satisfy the following criteria to be enrolled in this study:

  1. Signed Informed Consent Form
  2. Male or female patients who are 18-75 years of age
  3. Histologically confirmed ALCL, PTCL- NOS, ENKTCL nasal type, DLBCL-NOS and PMBCL
  4. Relapsed or 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
  5. At least 1 measurable lesion according to the Lugano Classification
  6. ECOG PS of 0 to 1 or equivalent Karnofsky PS Anticipated life expectancy >12 weeks

Exclusion Criteria:

  1. CNS involvement by malignancy

  2. Inadequate laboratory abnormalities at screening:

    Hgb ≤ 8.0 g/dL Total bilirubin > 1.5 x ULN (>2 x ULN for patients with Gilbert's syndrome) AST and ALT ≥ 5 x ULN CrCL ≤ 45 mL/min (as measured by Cockcroft-Gault equation) ANC ≤ 1000/uL Platelets ≤75,000/uL PR or INR >1.5 x ULN aPTT> 1.5 x ULN

  3. Active uncontrolled bleeding or a known bleeding diathesis
  4. Inadequate pulmonary function defined as pulse oximetry < 90% on room air
  5. Ongoing treatment with immunosuppressive drugs including calcineurin inhibitions, TNFalpha, mTOR, etc or chronic systemic corticosteroids (>10 mg/day prednisone or equivalent for >48 hours)

  6. Received prior therapy of:

    Anti-CD30 Ab based therapy within the previous 8 weeks Previous CD30.CAR-T investigational product Bi-specific CD30 Ab within the previous 8 weeks Allogenic HSCT in the last 180 days Autologous HSCT within 90 days

  7. Active GVHD requiring immune suppression regardless of grade
  8. HIV positive
  9. Active HBV and/or HCV
Contacts and Locations
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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): NCT04526834


Contacts
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Contact: Tessa Therapeutics +65 62352129 clinicaltrials@tessacell.com

Locations
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United States, California
City of Hope Recruiting
Duarte, California, United States, 91010
Contact: Matthew Mei, MD         
United States, Tennessee
Sarah Cannon Research Institute Recruiting
Nashville, Tennessee, United States, 37203
Contact: Ian Flinn, MD, PhD         
United States, Texas
Baylor College of Medicine Not yet recruiting
Houston, Texas, United States, 77030
Contact: Carlos Ramos, MD         
The University of Texas MD Anderson Cancer Centre Not yet recruiting
Houston, Texas, United States, 77030
Contact: Sairah Ahmed, MD    713-794-4374    sahmed3@mdanderson.org   
Sponsors and Collaborators
Tessa Therapeutics
Investigators
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Principal Investigator: Sairah Ahmed MD Anderson
More Information
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Responsible Party: Tessa Therapeutics
ClinicalTrials.gov Identifier: NCT04526834    
Other Study ID Numbers: TESSCAR002
First Posted: August 26, 2020    Key Record Dates
Last Update Posted: February 12, 2021
Last Verified: February 2021
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:
CD30, r/r NHL, DLBCL, ALCL, ENKTCL, PMBCL, PTCL, adult
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, Non-Hodgkin
Lymphoma, B-Cell
Lymphoma, T-Cell
Lymphoma, Large B-Cell, Diffuse
Lymphoma, Large-Cell, Anaplastic
Lymphoma, T-Cell, Peripheral
 Lymphoma, Extranodal NK-T-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases