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CAR T-cell Therapy

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

Duarte, CA
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
Must not have
Active GVHD requiring immune suppression regardless of grade
Anti-CD30 Ab based therapy within the previous 8 weeks
Timeline
Screening 3 weeks
Treatment Varies
Follow Up start of infusion of cd30.car-t (day 0) until year 5
Awards & highlights
No Placebo-Only Group

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.

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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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 75 years old.
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My cancer is one of the specified types of lymphoma.
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My CD30-positive NHL cancer did not respond to standard treatments.
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I am fully active or able to carry out light work.
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Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am currently on medication to suppress my immune system due to GVHD.
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I haven't had anti-CD30 antibody therapy in the last 8 weeks.
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I have not received a bi-specific CD30 antibody treatment in the last 8 weeks.
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I am not on long-term strong immune system suppressing drugs.
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I had a stem cell transplant using my own cells within the last 90 days.
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My cancer has spread to my brain or spinal cord.
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My kidney function, measured by CrCL, is 45 mL/min or less.
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I have a bleeding condition that is not under control.
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Timeline

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
To evaluate safety and dose limiting toxicities (DLT) of autologous CD30.CAR-T and establish the recommended Phase dose
Secondary study objectives
Duration of Response (DOR)
Objective Response Rate (ORR)
Progression Free Survival (PFS)
+1 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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

Find a Location

Closest Location:City of Hope· Duarte, CA

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
Anaplastic Lymphoma Research Study Groups: CD30 positive NHL subtypes
Anaplastic 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
~5 spots leftby Mar 2026
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