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

NCT04526834 | Active Not Recruiting Phase 1 FDA Drug

• 1 other identifier: TESSCAR002
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 4

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

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)

Keywords

CD30, r/r NHL, DLBCL, ALCL, ENKTCL, PMBCL, PTCL, adult

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• To evaluate pharmacokinetics of autologous CD30.CAR-T

  Start of infusion of CD30.CAR-T (Day 0) until year 5

• 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

• Duration of Response (DOR)

  Start of CD30.CAR-T (day 0) until progressive disease or death, whichever comes first, up to one year

• Progression Free Survival (PFS)

  Start of CD30.CAR-T (Day 0) until progressive disease or death, whichever comes first, up to one year

Study Arms (1)

CD30 positive NHL subtypes

EXPERIMENTAL

(ALCL, PTCL-NOS, ENKTCL, DLBCL-NOS, PMBCL) Dose Level 1 Dose Level 2 Dose Level 3

Drug: CD30.CAR-T

Interventions

CD30.CAR-T DRUG

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)

Also known as: CD30-directed genetically modified autologous T cells

CD30 positive NHL subtypes

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tessa Therapeutics: lead

Study Sites (4)

City of Hope

Duarte, California, 91010, United States

Location

Sarah Cannon Research Institute

Nashville, Tennessee, 37203, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

The University of Texas MD Anderson Cancer Centre

Houston, Texas, 77030, United States

Location

Related Publications (1)

• Ernst M, Oeser A, Besiroglu B, Caro-Valenzuela J, Abd El Aziz M, Monsef I, Borchmann P, Estcourt LJ, Skoetz N, Goldkuhle M. Chimeric antigen receptor (CAR) T-cell therapy for people with relapsed or refractory diffuse large B-cell lymphoma. Cochrane Database Syst Rev. 2021 Sep 13;9(9):CD013365. doi: 10.1002/14651858.CD013365.pub2.

  PMID: 34515338 DERIVED

MeSH Terms

Conditions

Lymphoma, Large-Cell, Anaplastic; Lymphoma, T-Cell, Peripheral; Lymphoma, Extranodal NK-T-Cell; Lymphoma, Large B-Cell, Diffuse

Condition Hierarchy (Ancestors)

Lymphoma, T-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Lymphoma, B-Cell

Study Officials

• Sairah Ahmed

  MD Anderson

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2020
• First Posted: August 26, 2020
• Study Start: September 8, 2021
• Primary Completion: November 22, 2022
• Study Completion (Estimated): March 1, 2036
• Last Updated: April 20, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)