Status:
ACTIVE_NOT_RECRUITING
Phase 1 Study of Autologous CD30.CAR-T in Relapsed or Refractory CD30 Positive Non-Hodgkin Lymphoma
Lead Sponsor:
Tessa Therapeutics
Conditions:
Anaplastic Large Cell Lymphoma
Peripheral T Cell Lymphoma
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
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 CD...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 8 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2036
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT04526834
Start Date
September 8 2021
End Date
March 1 2036
Last Update
April 20 2023
Active Locations (4)
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1
City of Hope
Duarte, California, United States, 91010
2
Sarah Cannon Research Institute
Nashville, Tennessee, United States, 37203
3
Baylor College of Medicine
Houston, Texas, United States, 77030
4
The University of Texas MD Anderson Cancer Centre
Houston, Texas, United States, 77030