Diffuse Large B Cell Lymphoma Clinical Trial
— CERTAINOfficial 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
Verified date | April 2023 |
Source | Tessa Therapeutics |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
Status | Active, not recruiting |
Enrollment | 21 |
Est. completion date | March 2036 |
Est. primary completion date | November 22, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | City of Hope | Duarte | California |
United States | Baylor College of Medicine | Houston | Texas |
United States | The University of Texas MD Anderson Cancer Centre | Houston | Texas |
United States | Sarah Cannon Research Institute | Nashville | Tennessee |
Lead Sponsor | Collaborator |
---|---|
Tessa Therapeutics |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To evaluate safety and dose limiting toxicities (DLT) of autologous CD30.CAR-T and establish the recommended Phase dose | Incidence of DLTs and occurrence of study related adverse events | Day 0 to 28 for DLT | |
Secondary | To evaluate pharmacokinetics of autologous CD30.CAR-T | AUC (copies/ug DNA over time) | Start of infusion of CD30.CAR-T (Day 0) until year 5 | |
Secondary | Objective Response Rate (ORR) | ORR | Start of CD30.CAR-T (Day 0) until progressive disease or start of new cancer therapy, whichever comes first, up to one year | |
Secondary | Duration of Response (DOR) | DOR | Start of CD30.CAR-T (day 0) until progressive disease or death, whichever comes first, up to one year | |
Secondary | Progression Free Survival (PFS) | PFS | Start of CD30.CAR-T (Day 0) until progressive disease or death, whichever comes first, up to one year |
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