Clinical Trials /

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

NCT04526834

Description:

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

Related Conditions:
  • Anaplastic Large Cell Lymphoma
  • Diffuse Large B-Cell Lymphoma, Not Otherwise Specified
  • Nasal Type Extranodal NK/T-Cell Lymphoma
  • Peripheral T-Cell Lymphoma, Not Otherwise Specified
  • Primary Mediastinal B-Cell Lymphoma
Recruiting Status:

Not yet recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

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

Clinical Trial IDs

  • ORG STUDY ID: TESSCAR002
  • NCT ID: NCT04526834

Conditions

  • 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)

Interventions

DrugSynonymsArms
CD30.CAR-TCD30-directed genetically modified autologous T cellsCD30 positive NHL subtypes

Purpose

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.
    

Trial Arms

NameTypeDescriptionInterventions
CD30 positive NHL subtypesExperimental(ALCL, PTCL-NOS, ENKTCL, DLBCL-NOS, PMBCL) Dose Level 1 Dose Level 2 Dose Level 3
  • CD30.CAR-T

Eligibility 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
      
Maximum Eligible Age:75 Years
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure: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
Safety Issue:
Description:Incidence of DLTs and occurrence of study related adverse events

Secondary Outcome Measures

Measure:To evaluate pharmacokinetics of autologous CD30.CAR-T
Time Frame:Start of infusion of CD30.CAR-T (Day 0) until year 5
Safety Issue:
Description:AUC (copies/ug DNA over time)
Measure: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
Safety Issue:
Description:ORR
Measure: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
Safety Issue:
Description:DOR
Measure: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
Safety Issue:
Description:PFS

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:Tessa Therapeutics

Trial Keywords

  • CD30, r/r NHL, DLBCL, ALCL, ENKTCL, PMBCL, PTCL, adult

Last Updated

August 25, 2020