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

Sponsor
Tessa Therapeutics (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04526834
Collaborator
(none)
21
Enrollment
4
Locations
1
Arm
173.7
Anticipated Duration (Months)
5.3
Patients Per Site
0
Patients Per Site Per Month

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:
Interventional
Anticipated 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 :
Sep 8, 2021
Anticipated Primary Completion Date :
Mar 1, 2023
Anticipated Study Completion Date :
Mar 1, 2036

Arms and Interventions

ArmIntervention/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]

      ORR

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

      PFS

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    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

    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

    Locations

    SiteCityStateCountryPostal Code
    1City of HopeDuarteCaliforniaUnited States91010
    2Sarah Cannon Research InstituteNashvilleTennesseeUnited States37203
    3Baylor College of MedicineHoustonTexasUnited States77030
    4The University of Texas MD Anderson Cancer CentreHoustonTexasUnited States77030

    Sponsors and Collaborators

    • Tessa Therapeutics

    Investigators

    • Principal Investigator: Sairah Ahmed, MD Anderson

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Tessa Therapeutics
    ClinicalTrials.gov Identifier:
    NCT04526834
    Other Study ID Numbers:
    • TESSCAR002
    First Posted:
    Aug 26, 2020
    Last Update Posted:
    Oct 6, 2021
    Last Verified:
    Oct 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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:

    Study Results

    No Results Posted as of Oct 6, 2021