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

  • End date
    Mar 13, 2036
  • participants needed
  • sponsor
    Tessa Therapeutics
Updated on 13 October 2021
measurable disease


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


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.

Condition anaplastic large cell lymphoma, diffuse large b cell lymphoma, Angiocentric T-cell lymphoma, Diffuse Large B-Cell Lymphoma, diffuse large cell lymphoma, Primary Mediastinal Large B Cell Lymphoma, extranodal nk/t-cell lymphoma, T-Cell Lymphoma, Peripheral T-Cell Lymphoma
Treatment CD30.CAR-T
Clinical Study IdentifierNCT04526834
SponsorTessa Therapeutics
Last Modified on13 October 2021


Yes No Not Sure

Inclusion Criteria

Eligibility is determined priori to leukapheresis. Patients must satisfy the
following criteria to be enrolled in this study
Signed Informed Consent Form
Male or female patients who are 18-75 years of age
Histologically confirmed ALCL, PTCL- NOS, ENKTCL nasal type, DLBCL-NOS and PMBCL
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
At least 1 measurable lesion according to the Lugano Classification
ECOG PS of 0 to 1 or equivalent Karnofsky PS Anticipated life expectancy >12 weeks

Exclusion Criteria

CNS involvement by malignancy
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
\. Active uncontrolled bleeding or a known bleeding diathesis
\. Inadequate pulmonary function defined as pulse oximetry < 90% on room air
\. Ongoing treatment with immunosuppressive drugs including calcineurin
inhibitions, TNFalpha, mTOR, etc or chronic systemic corticosteroids (>10
mg/day prednisone or equivalent for >48 hours)
\. 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
\. Active GVHD requiring immune suppression regardless of grade
\. HIV positive
\. Active HBV and/or HCV
Clear my responses

How to participate?

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What happens next?
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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