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

April 18, 2023 updated by: Tessa Therapeutics

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

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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Anticipated)

21

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Duarte, California, United States, 91010
        • City of Hope
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Sarah Cannon Research Institute
    • Texas
      • Houston, Texas, United States, 77030
        • Baylor College of Medicine
      • Houston, Texas, United States, 77030
        • The University of Texas MD Anderson Cancer Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 71 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Day 0 to 28 for DLT

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Start of infusion of CD30.CAR-T (Day 0) until year 5
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
Start of CD30.CAR-T (Day 0) until progressive disease or start of new cancer therapy, whichever comes first, up to one year
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
Start of CD30.CAR-T (day 0) until progressive disease or death, whichever comes first, up to one year
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
Start of CD30.CAR-T (Day 0) until progressive disease or death, whichever comes first, up to one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tessa Therapeutics

Investigators

  • Principal Investigator: Sairah Ahmed, MD Anderson

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 8, 2021

Primary Completion (Actual)

November 22, 2022

Study Completion (Anticipated)

March 1, 2036

Study Registration Dates

First Submitted

August 20, 2020

First Submitted That Met QC Criteria

August 25, 2020

First Posted (Actual)

August 26, 2020

Study Record Updates

Last Update Posted (Actual)

April 20, 2023

Last Update Submitted That Met QC Criteria

April 18, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TESSCAR002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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