← Back to Search

CAR T-cell Therapy

CAR T-cell Therapy for Lymphoma

Houston, TX

Phase 1

Recruiting

Led By Carlos Ramos, MD

Research Sponsored by Baylor College of Medicine

Eligibility Criteria Checklist

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

Must have

Estimated GFR > 70 mL/min.

Aggressive non-Hodgkin lymphoma

Must not have

Symptomatic cardiac disease (NYHA Class III or IV disease).

Received gemcitabine-containing chemotherapy within the previous 12 weeks

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new treatment for lymphoma that involves taking T cells from a healthy donor and engineering them to target two proteins found on the surface of lymphoma cells. Researchers hope that this will be a more effective treatment with fewer side effects than current treatments.

See full description

Who is the study for?

This trial is for patients aged 12-75 with certain types of lymphoma (Hodgkin's, non-Hodgkin's, or T-cell) that have returned or persisted after treatment. Participants must understand and sign consent, have a Karnofsky/Lansky score over 60%, normal organ function tests, and use effective birth control if sexually active. Those with recent other treatments, hypersensitivity to murine proteins, pregnancy, potential airway obstruction by tumor growth, high-dose steroid use or uncontrolled infections cannot join.Check my eligibility

What is being tested?

The study is testing allogeneic CD30.CAR-EBVST cells from healthy donors on patients whose lymphoma expresses the CD30 protein and may also contain EBV. The goal is to determine the highest safe dose following chemotherapy and assess its effectiveness in treating lymphoma.See study design

What are the potential side effects?

Potential side effects are not explicitly listed but may include typical reactions related to immune cell infusions such as fever, fatigue, allergic reactions to foreign proteins (from mouse origin), risk of infection due to immune system suppression post-chemotherapy and possible complications from targeting both CD30 protein and EBV.

Eligibility Criteria

Inclusion Criteria

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

Select...

My kidney function is good.

show original

Select...

My condition is aggressive non-Hodgkin lymphoma.

show original

Select...

My tumor is CD30 positive as confirmed by a certified lab.

show original

Select...

My available T cells are modified to target cancer and tested positive for CD30CAR.

show original

Select...

I am mostly independent and can care for myself.

show original

Select...

My diagnosis is one of the specified types of lymphoma or I have a CD30-positive tumor.

show original

Select...

I am between 12 and 75 years old.

show original

Select...

My condition is ALK-negative T-cell lymphoma.

show original

Select...

My lymphoma is ALK-positive.

show original

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have severe heart disease that limits my daily activities.

show original

Select...

I have received chemotherapy that included gemcitabine in the last 12 weeks.

show original

Select...

I do not have any serious, uncontrolled infections.

show original

Select...

I have taken a trial medication within the last 2 weeks.

show original

Select...

I am currently taking more than 10 mg/day of steroids like prednisone.

show original

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Dose limiting toxicity rate (DLT) by CTCAE 5.0

Secondary study objectives

Duration of SD

Duration of response

Progression free survival (PFS)

+2 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: Treatment PhaseExperimental Treatment1 Intervention

Four dose levels will be evaluated based on safety data from our current study of CD30 CAR T cells. Cohorts of three to six patients will be enrolled at each dose level The dose is based on the number of CD.30 CAR-EBVT-expressing cells administered. The total number of dose levels evaluated will depend upon toxicities experienced. Dose level cohorts will be numbered sequentially. * Dose Level 1: 4 × 10\^7 CD30.CAR-EBVST cells * Dose Level 2: 1 × 10\^8 CD30.CAR-EBVST cells * Dose Level 3: 4 × 10\^8 CD30.CAR-EBVST cells * Dose Level 4: 8 × 10\^8 CD30.CAR-EBVST cells

0 / 14Eligibility criteria met