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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

Tracking Information
First Submitted Date  ICMJE August 20, 2020
First Posted Date  ICMJE August 26, 2020
Last Update Posted Date February 12, 2021
Actual Study Start Date  ICMJE November 20, 2020
Estimated Primary Completion Date February 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 25, 2020)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 25, 2020)
  • 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)
  • 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
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Phase 1 Study of Autologous CD30.CAR-T in Relapsed or Refractory CD30 Positive Non-Hodgkin Lymphoma
Official Title  ICMJE 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
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
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • 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)
Intervention  ICMJE 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
Study Arms  ICMJE Experimental: CD30 positive NHL subtypes

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

Dose Level 1

Dose Level 2

Dose Level 3

Intervention: Drug: CD30.CAR-T
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 25, 2020)
21
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 2023
Estimated Primary Completion Date February 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Tessa Therapeutics +65 62352129 clinicaltrials@tessacell.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04526834
Other Study ID Numbers  ICMJE TESSCAR002
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Tessa Therapeutics
Study Sponsor  ICMJE Tessa Therapeutics
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Sairah Ahmed MD Anderson
PRS Account Tessa Therapeutics
Verification Date February 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP