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

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. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT04526834
Recruitment Status : Active, not recruiting
First Posted : August 26, 2020
Last Update Posted : November 22, 2022
Information provided by (Responsible Party):
Tessa Therapeutics

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.

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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 : September 8, 2021
Estimated Primary Completion Date : March 2023
Estimated Study Completion Date : March 2036

Arm Intervention/treatment
Experimental: CD30 positive NHL subtypes


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

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 ]

  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 ]

  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 ]

Information from the National Library of Medicine

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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

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

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

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United States, California
City of Hope
Duarte, California, United States, 91010
United States, Tennessee
Sarah Cannon Research Institute
Nashville, Tennessee, United States, 37203
United States, Texas
Baylor College of Medicine
Houston, Texas, United States, 77030
The University of Texas MD Anderson Cancer Centre
Houston, Texas, United States, 77030
Sponsors and Collaborators
Tessa Therapeutics
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Principal Investigator: Sairah Ahmed MD Anderson
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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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: November 22, 2022
Last Verified: November 2022
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:
Additional relevant MeSH terms:
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Lymphoma, B-Cell
Lymphoma, T-Cell
Lymphoma, T-Cell, Peripheral
Lymphoma, Large B-Cell, Diffuse
Lymphoma, Large-Cell, Anaplastic
Lymphoma, Extranodal NK-T-Cell
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin