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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. 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: NCT04526834
Recruitment Status : Not yet recruiting
First Posted : August 26, 2020
Last Update Posted : October 22, 2020
Sponsor:
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
Estimated Study Start Date : November 2020
Estimated Primary Completion Date : February 2022
Estimated Study Completion Date : February 2023


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




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



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
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

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@tessatherapeutics.com

Sponsors and Collaborators
Tessa Therapeutics
Investigators
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Principal Investigator: Sairah Ahmed MD Anderson
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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: October 22, 2020
Last Verified: October 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:
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