Phase 2 Study Evaluating Autologous CD30.CAR-T Cells in Patients With Relapsed/Refractory Hodgkin Lymphoma (CHARIOT)

NCT04268706 | Active Not Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: TESSCAR001
• Study Type: interventional
• Target: 97
• Locations: 1 country
• Sites: 5

Brief Summary

This is a two-part, Phase 2, multicenter, open-label, single arm study to evaluate the safety and efficacy of autologous CD30.CAR-T in adult and pediatric subjects with relapsed or refractory CD30+ classical Hodgkin Lymphoma.

Conditions

Hodgkin Lymphoma, Adult; Hodgkin Disease Recurrent; Hodgkin Disease Refractory; Hodgkin Disease, Pediatric

Keywords

r/r Hodgkin Lymphoma, CD30, adult, pediatrics

Outcome Measures

Primary Outcomes (2)

• Pilot: Safety of autologous CD30.CAR-T

  Adverse events

  Minimum 24 months post-CD30.CAR-T infusion

• Pivotal: Anti-tumor effect of autologous CD30.CAR-T using objective response rate (ORR) as assessed by an Independent Radiology Review Committee (IRRC) per the Revised Criteria for Response Assessment: The Lugano Classification (Cheson, 2014)

  ORR

  As early as 6 weeks after CD30.CAR-T treatment

Secondary Outcomes (11)

• Pilot: Antitumor efficacy of autologous CD30.CAR-T using objective response rate (ORR) as assessed by an Independent Radiology Review Committee (IRRC) per the Revised Criteria for Response Assessment: The Lugano Classification (Cheson et al., 2014)

  As early as 6 weeks after CD30.CAR-T treatment

• Pilot: Duration of Response

  Minimum 24 months post-CD30.CAR-T infusion

• Pilot: Progression Free Survival

  Minimum 24 months post-CD30.CAR-T infusion

• Pilot: Overall Survival

  Minimum 24 months post-CD30.CAR-T infusion

• Pilot: Health Related quality of life (HRQoL) questionnaire

  Minimum 24 months post-CD30.CAR-T infusion

Study Arms (1)

CD30 positive r/r classical Hodgkin Lymphoma

EXPERIMENTAL

Patients with relapsed or refractory classical Hodgkin Lymphoma who have failed 3 prior lines of treatment, which may include a prior autologous and/or allogeneic stem cell transplant. Patients will be treated with autologous CD30.CAR-T cells.

Drug: CD30.CAR-T; Drug: Fludarabine; Drug: Bendamustine

Interventions

CD30.CAR-T DRUG

Autologous CD30.CAR-T cells infused on Day 0 after the completion of lymphodepleting chemotherapy.

CD30 positive r/r classical Hodgkin Lymphoma

Fludarabine DRUG

Lymphodepletion chemotherapy (30 mg/m2/day) for 3 consecutive days

Also known as: Fludara

CD30 positive r/r classical Hodgkin Lymphoma

Bendamustine DRUG

Lymphodepletion chemotherapy (70 mg/m2/day) for 3 consecutive days

Also known as: Bendeka

CD30 positive r/r classical Hodgkin Lymphoma

Eligibility Criteria

• Age: 12 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Eligibility is determined prior to blood collection . Patients must satisfy the following criteria to be enrolled in the study:
• Signed Informed Consent Form
• Male or female patients who are 12 - 75 years of age
• Histologically confirmed classical Hodgkin Lymphoma
• Relapsed or refractory cHL that has failed at least 3 prior lines of therapy, including:
• chemotherapy
• BV and/or
• PD-1 inhibitor Patients may have previously received an autologous and/or allogeneic stem cell transplant
• CD30-positive tumor
• At least 1 measurable lesion according to The Lugano Classification
• Laboratory parameters: Hematological, renal and hepatic functions, and coagulation parameters
• Hgb ≥ 8.0 g/dL
• Total bilirubin ≤ 1.5 × ULN
• AST and ALT ≤ 5 × the ULN
• CrCl \> 45 mL/min

You may not qualify if:

• Evidence of lymphomatous involvement of central nervous system (CNS)
• Presence of clinically relevant or active seizure disorder, stroke, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease with central nervous system (CNS) involvement
• Active uncontrolled bleeding or a known bleeding diathesis
• Inadequate pulmonary function defined as pulse oximetry \< 90% on room air
• ECHO or MUGA with LVEF \< 45%
• On-going treatment with immunosuppressive drugs or chronic systemic corticosteroids
• Having received:
• Anti-CD30 antibody-based therapy within 4 weeks prior to CD30.CAR-T infusion
• Prior investigational CD30.CAR-T
• CD30 bispecific agent within 8 weeks prior to CD30.CAR-T infusion
• Autologous HSCT within 90 days or allogeneic HSCT within 180 days prior to CD30.CAR-T infusion
• Currently receiving any investigational agents within 4 weeks prior to study enrollment; or received any tumor vaccines within 6 weeks prior to CD30.CAR-T infusion
• Active acute or chronic graft versus host disease (GVHD) requiring immune suppression regardless of grade
• Evidence of human immunodeficiency virus (HIV) infection
• Seropositive for and with evidence of active viral infection with hepatitis B virus (HBV) or hepatitis C virus (HCV)

Sponsors & Collaborators

• Tessa Therapeutics: lead

Study Sites (5)

City of Hope Comprehensive Cancer Center

Duarte, California, 91010, United States

Location

University of Chicago Medical Center

Chicago, Illinois, 60637, United States

Location

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Sarah Cannon Research Institute

Nashville, Tennessee, 37203, United States

Location

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Hodgkin Disease

Interventions

fludarabine; fludarabine phosphate; Bendamustine Hydrochloride

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Helen Heslop, MD

  Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 11, 2020
• First Posted: February 13, 2020
• Study Start: February 1, 2021
• Primary Completion: May 1, 2025
• Study Completion (Estimated): March 1, 2037
• Last Updated: April 5, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)