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

Tessa Therapeutics (Industry)
Overall Status
Active, not recruiting
CT.gov ID

Study Details

Study Description

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 Design

Study Type:
Anticipated Enrollment :
21 participants
Intervention Model:
Single Group Assignment
None (Open Label)
Primary Purpose:
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 :
Sep 8, 2021
Anticipated Primary Completion Date :
Mar 1, 2023
Anticipated Study Completion Date :
Mar 1, 2036

Arms and Interventions

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 Names:
  • CD30-directed genetically modified autologous T cells
  • Outcome Measures

    Primary Outcome Measures

    1. To evaluate safety and dose limiting toxicities (DLT) of autologous CD30.CAR-T and establish the recommended Phase dose [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 [Start of infusion of CD30.CAR-T (Day 0) until year 5]

      AUC (copies/ug DNA over time)

    2. Objective Response Rate (ORR) [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) [Start of CD30.CAR-T (day 0) until progressive disease or death, whichever comes first, up to one year]


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


    Eligibility Criteria


    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    Accepts Healthy Volunteers:
    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

    1. Active uncontrolled bleeding or a known bleeding diathesis

    2. Inadequate pulmonary function defined as pulse oximetry < 90% on room air

    3. Ongoing treatment with immunosuppressive drugs including calcineurin inhibitions, TNFalpha, mTOR, etc or chronic systemic corticosteroids (>10 mg/day prednisone or equivalent for >48 hours)

    4. 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

    1. Active GVHD requiring immune suppression regardless of grade

    2. HIV positive

    3. Active HBV and/or HCV

    Contacts and Locations


    Site City State Country Postal Code
    1 City of Hope Duarte California United States 91010
    2 Sarah Cannon Research Institute Nashville Tennessee United States 37203
    3 Baylor College of Medicine Houston Texas United States 77030
    4 The University of Texas MD Anderson Cancer Centre Houston Texas United States 77030

    Sponsors and Collaborators

    • Tessa Therapeutics


    • Principal Investigator: Sairah Ahmed, MD Anderson

    Study Documents (Full-Text)

    None provided.

    More Information


    None provided.
    Responsible Party:
    Tessa Therapeutics
    ClinicalTrials.gov Identifier:
    Other Study ID Numbers:
    • TESSCAR002
    First Posted:
    Aug 26, 2020
    Last Update Posted:
    Jul 22, 2022
    Last Verified:
    Oct 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Plan to Share IPD:
    Studies a U.S. FDA-regulated Drug Product:
    Studies a U.S. FDA-regulated Device Product:
    Keywords provided by Tessa Therapeutics
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jul 22, 2022