Autologous CD30.CAR-T for Classical Hodgkin's Lymphoma

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
University of Miami, Miami, FL
Classical Hodgkin's Lymphoma+4 More
Autologous CD30.CAR-T - Drug
Eligibility
Any Age
All Sexes
What conditions do you have?
Select

Study Summary

This is a Phase 1b, multicenter, open-label, single arm study to evaluate the safety and efficacy of the combination therapy, CD30.CAR-T and the programmed cell death protein-1 (PD-1) checkpoint inhibitor, nivolumab, in patients aged 12 years of age and above with relapsed or refractory classical Hodgkin lymphoma (cHL) following failure of standard frontline therapy.

Eligible Conditions

  • Classical Hodgkin's Lymphoma
  • recurrent Hodgkin's Disease
  • Hodgkin Disease

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Classical Hodgkin's Lymphoma

Study Objectives

1 Primary · 4 Secondary · Reporting Duration: Through study completion, an average of 3 years from Leukapheresis

Day 28
Safety of autologous CD30.CAR-T in combination with nivolumab
Year 3
Duration of response
Overall response rate
Overall survival
Pharmacokinetics - Area under the curve
Pharmacokinetics - Maximum concentration (Cmax)
Pharmacokinetics - Time of maximum concentration (Tmax)
Progression-free survival
Week 10
Anti-tumor activity using CR rate of autologous CD30.CAR-T in combination with nivolumab

Trial Safety

Safety Progress

1 of 3

Other trials for Classical Hodgkin's Lymphoma

Trial Design

1 Treatment Group

Nivolumab and CD30.CAR-T
1 of 1
Experimental Treatment

15 Total Participants · 1 Treatment Group

Primary Treatment: Autologous CD30.CAR-T · No Placebo Group · Phase 1

Nivolumab and CD30.CAR-TExperimental Group · 4 Interventions: Nivolumab, Autologous CD30.CAR-T, Bendamustine, Fludarabine · Intervention Types: Drug, Drug, Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nivolumab
2014
Completed Phase 3
~5540
Bendamustine
2008
Completed Phase 3
~2660
Fludarabine
2012
Completed Phase 2
~1240

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: through study completion, an average of 3 years from leukapheresis
Closest Location: University of Miami · Miami, FL
Photo of University of Miami 1Photo of University of Miami 2Photo of University of Miami 3
1991First Recorded Clinical Trial
1 TrialsResearching Classical Hodgkin's Lymphoma
620 CompletedClinical Trials

Who is running the clinical trial?

Tessa TherapeuticsLead Sponsor
3 Previous Clinical Trials
448 Total Patients Enrolled
Bristol-Myers SquibbIndustry Sponsor
2,462 Previous Clinical Trials
3,908,000 Total Patients Enrolled
1 Trials studying Classical Hodgkin's Lymphoma
54 Patients Enrolled for Classical Hodgkin's Lymphoma
Helen Heslop, MDPrincipal InvestigatorBaylor College of Medicine
7 Previous Clinical Trials
225 Total Patients Enrolled
Sairah Ahmed, MDPrincipal InvestigatorM.D. Anderson Cancer Center
1 Previous Clinical Trials
2 Total Patients Enrolled

Eligibility Criteria

Age Any Age · All Participants · 8 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have adequate laboratory parameters.
If you are expected to live longer than 12 weeks, you are eligible for this study.
You have a minimum age of 12 years.
You have relapsed or refractory CD30+ cHL following failure of a standard frontline chemotherapy.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.