Phase 2 Study Evaluating Autologous CD30.CAR-T Cells in Patients With

Status Active, not recruiting

Clinical Trial 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.

Clinical Trial Description

The Pilot part of the study will evaluate the safety, tolerability, and preliminary antitumor efficacy of CD30.CAR-T. The Pivotal part of the study will evaluate antitumor efficacy and further evaluate safety and tolerability. All study eligibility requirements, assessments, procedures, and follow-up are the same for patients in both Pilot and Pivotal parts of the study. Subjects who meet eligibility criteria will have their blood drawn by leukapheresis for manufacture the CD30.CAR-T cells. Subjects are allowed bridging chemotherapy, as per Investigator choice, while waiting for production of CD30.CAR-T. Lymphodepletion (LD) with fludarabine and bendamustine will be administered for 3 consecutive days starting on Day -5 to Day -3, prior to CD30.CAR-T infusion, which will be administered on Day 0 as a single IV infusion. Depending on disease status, eligible subjects may receive up to a total of two CD30.CAR-T infusions at the same dose, each with preceding LD chemotherapy. Subjects will be closely monitored for safety and efficacy throughout the Treatment Period until the end of study (EOS) visit at Month 24. Subjects will be followed for survival, withdrawal of consent or study closure, whichever occurs first. Health Related Quality of Life assessments will also be collected throughout the study. After the EOS visit, subjects will enter the long-term follow-up phase (LTFU) which will include survival follow-up, additional safety, efficacy and biomarker assessments, as clinically indicated. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04268706
Study type	Interventional
Source	Tessa Therapeutics
Contact
Status	Active, not recruiting
Phase	Phase 2
Start date	February 1, 2021
Completion date	March 2037

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See also
Status	Clinical Trial	Phase
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Not yet recruiting	`NCT06421987` - Cardiopulmonary Function and Cerebral Blood Flow in Hodgkin Lymphoma Survivors
Recruiting	`NCT05597761` - Immunogenicity of COVID-19 Vaccination in Autologous HSCT or CAR-T Cells Recipients
Active, not recruiting	`NCT03535948` - Elderly Hodgkin Lymphoma Patients Treated With Chemoradiotherapy
Completed	`NCT03155425` - PD-1 Antibody SHR-1210 in Patients With Relapsed or Refractory Classic Hodgkin's Lymphoma	Phase 2
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Recruiting	`NCT05137886` - PD-1 Inhibitor Combined With Decitabine Followed by ASCT as Second-line Therapy for Relapsed or Refractory Classic Hodgkin's Lymphoma	Phase 2
Recruiting	`NCT05798897` - Safety and Preliminary Efficacy of MT-601 in Patients With Relapsed/Refractory Lymphoma	Phase 1
Completed	`NCT04292626` - Molecular Imaging of Lymphoma Using Labeled Technetium-99m 1-Thio-D-Glucose	Phase 1
Recruiting	`NCT04638790` - First Line Chemotherapy for Classical Hodgkin Lymphoma in Russia (HL-Russia-1)	Phase 3
Completed	`NCT01578967` - Induction Chemo w/ABVD Followed by Brentuximab Vedotin Consolidation in Newly Diagnosed, Non-Bulky Stage I/II Hodgkin Lymphoma	N/A
No longer available	`NCT03914885` - Compassionate Use Re-Infusion of ATLCAR.CD30

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms