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

NCT04268706 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 97

Last updated 2023-04-05

No results posted yet for this study

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

Interventions

DRUG

CD30.CAR-T

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

DRUG

Fludarabine

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

DRUG

Bendamustine

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

Sponsors & Collaborators

  • Tessa Therapeutics

    lead INDUSTRY

Principal Investigators

  • Helen Heslop, MD · Baylor College of Medicine

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
12 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-02-01
Primary Completion
2025-05-31
Completion
2037-03-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04268706 on ClinicalTrials.gov