← Back to Search

CAR T-cell Therapy

CAR-T Cell Therapy for Non-Hodgkin's Lymphoma (CERTAIN Trial)

Phase 1

Waitlist Available

Led By Sairah Ahmed

Research Sponsored by Tessa Therapeutics

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Male or female patients who are 18-75 years of age

Histologically confirmed ALCL, PTCL- NOS, ENKTCL nasal type, DLBCL-NOS and PMBCL

Timeline

Screening 3 weeks

Treatment Varies

Follow Up start of infusion of cd30.car-t (day 0) until year 5

Awards & highlights

CERTAIN Trial Summary

This trial is testing a new cancer treatment that uses the patient's own immune cells. They will be injected with a virus that makes their cells attack cancer cells.

Who is the study for?

Adults aged 18-75 with certain types of Non-Hodgkin Lymphoma that have relapsed or are not responding to treatment can join. They should be relatively healthy, able to perform daily activities, and have a life expectancy over 12 weeks. People with severe kidney issues, low blood counts, significant liver problems, active bleeding disorders, poor lung function or those on strong immune-suppressing drugs cannot participate.Check my eligibility

What is being tested?

The trial is testing a new therapy called CD30.CAR-T cells in patients whose lymphoma cells express the CD30 marker and who haven't responded well to other treatments. It's an early-phase study focusing on safety and what doses are safe without causing too many side effects.See study design

What are the potential side effects?

Potential side effects may include reactions related to the immune system attacking normal tissues (autoimmune reactions), symptoms at the infusion site like pain or swelling, general feelings of being unwell such as fatigue or fever, and changes in blood cell counts which could increase infection risk.

CERTAIN Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 18 and 75 years old.

Select...

My cancer is one of the specified types of lymphoma.

Select...

My CD30-positive NHL cancer did not respond to standard treatments.

Select...

I am fully active or able to carry out light work.

CERTAIN Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ start of infusion of cd30.car-t (day 0) until year 5

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~start of infusion of cd30.car-t (day 0) until year 5

This trial's timeline: 3 weeks for screening, Varies for treatment, and start of infusion of cd30.car-t (day 0) until year 5 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

To evaluate safety and dose limiting toxicities (DLT) of autologous CD30.CAR-T and establish the recommended Phase dose

Secondary outcome measures

Duration of Response (DOR)

Objective Response Rate (ORR)

Progression Free Survival (PFS)

+1 more

CERTAIN Trial Design

1Treatment groups

Experimental Treatment

Group I: CD30 positive NHL subtypesExperimental Treatment1 Intervention

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

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Tessa TherapeuticsLead Sponsor

3 Previous Clinical Trials

442 Total Patients Enrolled

Sairah AhmedPrincipal InvestigatorMD Anderson

1 Previous Clinical Trials

2 Total Patients Enrolled

Media Library

CD30.CAR-T (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04526834 — Phase 1

Extranodal Lymphoma Research Study Groups: CD30 positive NHL subtypes

Extranodal Lymphoma Clinical Trial 2023: CD30.CAR-T Highlights & Side Effects. Trial Name: NCT04526834 — Phase 1

CD30.CAR-T (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04526834 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is my profile compatible with the criteria for joining this research undertaking?

"The aim of this medical trial is to recruit 21 individuals who have been diagnosed with lymphoma, and are between 18-75 years old."

Answered by AI

What can be said regarding the security of CD30.CAR-T treatments for patients?

"Given its Phase 1 status, where data supporting safety and efficacy is relatively sparse, CD30.CAR-T received a score of 1 in our team's evaluation at Power."

Answered by AI

Is enrollment for this research project currently accessible?

"According to clinicaltrials.gov, this medical experiment is not in the process of recruiting patients. The trial was initially uploaded on September 8th 2021 and updated most recently on November 21st 2022. Despite that fact, there are 1,820 other trials which currently have open enrolment spots available for individuals interested in participating."

Answered by AI

Is the age restriction for this study limited to individuals under seventy-five years old?

"This study requires participants to be in the age range of 18-75. For those below or above this bracket, there are 325 trials for those under 18 and 1655 studies for senior citizens."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2021. "Phase 1 Study of Autologous CD30.CAR-T in Relapsed or Refractory CD30 Positive Non-Hodgkin Lymphoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04526834.