Description:
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
Title
- Brief Title: Phase 1 Study of Autologous CD30.CAR-T in Relapsed or Refractory CD30 Positive Non-Hodgkin Lymphoma
- Official 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
Clinical Trial IDs
- ORG STUDY ID:
TESSCAR002
- NCT ID:
NCT04526834
Conditions
- Anaplastic Large Cell Lymphoma
- Peripheral T Cell Lymphoma
- Extranodal NK/T-cell Lymphoma
- Diffuse Large B Cell Lymphoma
- Primary Mediastinal Large B-Cell Lymphoma (PMBCL)
Interventions
Drug | Synonyms | Arms |
---|
CD30.CAR-T | CD30-directed genetically modified autologous T cells | CD30 positive NHL subtypes |
Purpose
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.
Trial Arms
Name | Type | Description | Interventions |
---|
CD30 positive NHL subtypes | Experimental | (ALCL, PTCL-NOS, ENKTCL, DLBCL-NOS, PMBCL)
Dose Level 1
Dose Level 2
Dose Level 3 | |
Eligibility Criteria
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
Maximum Eligible Age: | 75 Years |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | 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 |
Safety Issue: | |
Description: | Incidence of DLTs and occurrence of study related adverse events |
Secondary Outcome Measures
Measure: | To evaluate pharmacokinetics of autologous CD30.CAR-T |
Time Frame: | Start of infusion of CD30.CAR-T (Day 0) until year 5 |
Safety Issue: | |
Description: | AUC (copies/ug DNA over time) |
Measure: | Objective Response Rate (ORR) |
Time Frame: | Start of CD30.CAR-T (Day 0) until progressive disease or start of new cancer therapy, whichever comes first, up to one year |
Safety Issue: | |
Description: | ORR |
Measure: | Duration of Response (DOR) |
Time Frame: | Start of CD30.CAR-T (day 0) until progressive disease or death, whichever comes first, up to one year |
Safety Issue: | |
Description: | DOR |
Measure: | Progression Free Survival (PFS) |
Time Frame: | Start of CD30.CAR-T (Day 0) until progressive disease or death, whichever comes first, up to one year |
Safety Issue: | |
Description: | PFS |
Details
Phase: | Phase 1 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | Tessa Therapeutics |
Trial Keywords
- CD30, r/r NHL, DLBCL, ALCL, ENKTCL, PMBCL, PTCL, adult
Last Updated
March 16, 2021