CERTAIN: Phase 1 Study of Autologous CD30.CAR-T in Relapsed or Refractory CD30 Positive Non-Hodgkin Lymphoma
Study Details
Study Description
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
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
Phase 1 |
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
Arms and Interventions
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:
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Outcome Measures
Primary Outcome Measures
- To evaluate safety and dose limiting toxicities (DLT) of autologous CD30.CAR-T and establish the recommended Phase dose [Day 0 to 28 for DLT]
Incidence of DLTs and occurrence of study related adverse events
Secondary Outcome Measures
- To evaluate pharmacokinetics of autologous CD30.CAR-T [Start of infusion of CD30.CAR-T (Day 0) until year 5]
AUC (copies/ug DNA over time)
- 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]
ORR
- Duration of Response (DOR) [Start of CD30.CAR-T (day 0) until progressive disease or death, whichever comes first, up to one year]
DOR
- Progression Free Survival (PFS) [Start of CD30.CAR-T (Day 0) until progressive disease or death, whichever comes first, up to one year]
PFS
Eligibility Criteria
Criteria
Inclusion Criteria:
Eligibility is determined priori to leukapheresis. Patients must satisfy the following criteria to be enrolled in this study:
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Signed Informed Consent Form
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Male or female patients who are 18-75 years of age
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Histologically confirmed ALCL, PTCL- NOS, ENKTCL nasal type, DLBCL-NOS and PMBCL
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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
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At least 1 measurable lesion according to the Lugano Classification
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ECOG PS of 0 to 1 or equivalent Karnofsky PS Anticipated life expectancy >12 weeks
Exclusion Criteria:
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CNS involvement by malignancy
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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
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Active uncontrolled bleeding or a known bleeding diathesis
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Inadequate pulmonary function defined as pulse oximetry < 90% on room air
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Ongoing treatment with immunosuppressive drugs including calcineurin inhibitions, TNFalpha, mTOR, etc or chronic systemic corticosteroids (>10 mg/day prednisone or equivalent for >48 hours)
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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
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Active GVHD requiring immune suppression regardless of grade
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HIV positive
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Active HBV and/or HCV
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
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 |
Sponsors and Collaborators
- Tessa Therapeutics
Investigators
- Principal Investigator: Sairah Ahmed, MD Anderson
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- TESSCAR002