Phase 1 Study of Autologous CD30.CAR-T in Relapsed or Refractory CD30 Positive Non-Hodgkin Lymphoma

Diffuse Large B Cell Lymphoma Clinical Trial

— CERTAIN  

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 Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04526834
• Other study ID #: TESSCAR002
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: September 8, 2021
• Est. completion date: March 2036

Study information

• Verified date: April 2023
• Source: Tessa Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Anaplastic Large Cell Lymphoma
• Diffuse Large B Cell Lymphoma
• Extranodal NK/T-cell Lymphoma
• Lymphoma
• Lymphoma, B-Cell
• Lymphoma, Extranodal NK-T-Cell
• Lymphoma, Large B-Cell, Diffuse
• Lymphoma, Large-Cell, Anaplastic
• Lymphoma, Non-Hodgkin
• Lymphoma, T-Cell
• Lymphoma, T-Cell, Peripheral
• Peripheral T Cell Lymphoma
• Primary Mediastinal Large B-Cell Lymphoma (PMBCL)

Intervention

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)

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Tessa Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

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