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Clinical Trials/NCT04526834
NCT04526834Active, not recruitingPhase 1

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

Tessa Therapeutics4 sites in 1 country21 target enrollmentStarted: September 8, 2021Last updated:
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Conditions
Interventions

Trial Snapshot

Phase
Phase 1
Status
Active, not recruiting
Sponsor
Enrollment
21
Locations
4
Primary Endpoint
To evaluate safety and dose limiting toxicities (DLT) of autologous CD30.CAR-T and establish the recommended Phase dose
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 75 Years (Adult, Older Adult)
Sex
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:
  • •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

Arms & Interventions

CD30 positive NHL subtypes

Experimental

(ALCL, PTCL-NOS, ENKTCL, DLBCL-NOS, PMBCL)

Dose Level 1

Dose Level 2

Dose Level 3

Intervention: CD30.CAR-T (Drug)

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • 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)
  • Progression Free Survival (PFS)(Start of CD30.CAR-T (Day 0) until progressive disease or death, whichever comes first, up to one year)
  • To evaluate pharmacokinetics of autologous CD30.CAR-T(Start of infusion of CD30.CAR-T (Day 0) until year 5)
  • Duration of Response (DOR)(Start of CD30.CAR-T (day 0) until progressive disease or death, whichever comes first, up to one year)

Investigators

Sponsor
Tessa Therapeutics
Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (4)

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