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CAR T-cell Therapy

TAA-Specific CTL Therapy for Lymphoma (TACTAL Trial)

Phase 1

Waitlist Available

Led By Geoge Carrum, 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

PROCUREMENT: Any patient regardless of sex, with a diagnosis of Hodgkin or non-Hodgkin lymphoma

TREATMENT: Patients should have been off conventional therapy for at least 1 week prior to entry in this study, including rituximab

Must not have

PROCUREMENT: Patients receiving systemic corticosteroids

TREATMENT: Known or suspected hypersensitivity to azacitidine or mannitol

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial is for patients who have a type of lymph gland disease called Hodgkin or non-Hodgkin lymphoma which has come back, or may come back, or has not gone away after treatment. This is a research study using special immune system cells called tumor associated antigen (TAA)-specific cytotoxic T lymphocytes, a new experimental therapy.

Who is the study for?

This trial is for adults and children with Hodgkin or non-Hodgkin lymphoma that has returned after treatment, hasn't responded to treatment, or as a second cancer. Participants need a certain level of hemoglobin, normal organ function tests, and must not be pregnant. They should not have severe infections, HIV, hepatitis B/C infection or be on systemic steroids.

What is being tested?

The study is testing TAA-specific cytotoxic T lymphocytes (CTLs), which are immune cells designed to target proteins commonly found on lymphoma cells. Some adult patients will also receive azacytidine before the CTLs to potentially enhance the effectiveness of the therapy.

What are the potential side effects?

Potential side effects may include reactions related to immune response such as inflammation in various organs due to targeted cell destruction by CTLs. Azacytidine can cause blood disorders, gastrointestinal symptoms and injection site reactions.

Eligibility Criteria

Inclusion Criteria

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

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I have been diagnosed with Hodgkin or non-Hodgkin lymphoma.

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I haven't received any standard cancer treatments, including rituximab, for at least a week.

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I am 18 or older and have had a stem cell transplant from myself or an identical twin.

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I am under 18 and have an active disease.

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My oxygen level is above 95% without extra oxygen after having radiation therapy.

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I can do most activities but may need help.

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My kidney function, measured by creatinine, is within the normal range for my age.

Exclusion Criteria

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

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I am currently taking corticosteroids.

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I am allergic to azacitidine or mannitol.

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I am currently taking corticosteroids.

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I am currently dealing with a severe infection.

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I am not pregnant or breastfeeding.

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I do not have an active HIV, hepatitis B, or hepatitis C infection.

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I have advanced liver cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Assessment of patients with adverse events

Number of Patients with treatment related Serious Adverse Events

Secondary study objectives

Assessment of increasing the spectrum of epitopes/antigens

Obtain information on the expansion, persistence and anti-tumor effects of the adoptively-transferred TAA-specific CTLs

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups

Experimental Treatment

Group I: azacytidine and multiTAA T cells StageExperimental Treatment1 Intervention

This phase will administer aza intravenously at a dose of 75 mg/m2 after premedication with an anti-emetic such as ondansetron po or IV (up to a maximum dose of 16 mg ondansetron or equivalent). This phase will determine whether infusion of TAA-specific T cells (at dose level 2 - 1x10\^7) targeting multiple tumor antigens in combination with azacytidine is safe, and whether CTL infusions (with or without azacytidine) increase the spectrum of epitopes/antigens targeted by endogenous T cells (epitope spreading).

Group II: Pediatric multiTAA T cells StageExperimental Treatment1 Intervention

This phase will give patients \< 18 years old two infusions (on Day 0 and Day 14) of multi-TAA specific T cells at a fixed dose of 1x10\^7 cells/m2. This phase will test the safety and efficacy of multiTAA-specific T cells in pediatric patients with active HL/NHL.

Group III: Dose-Escalation Study StageExperimental Treatment1 Intervention

In the dose escalation stage, three dose levels will be studied. Patients in the dose escalation portion of the study will be entered and stratified separately to the following two groups: Group A: Patients receiving CTLs as therapy for Hodgkin's or non-Hodgkin's lymphoma. Group B: Patients receiving CTLs as adjunctive therapy following autologous or syngeneic transplant.

Group IV: Antigen-Escalation StageExperimental Treatment1 Intervention

The first stage will be an "antigen-escalation" stage using a fixed total dose of cells (5 x 10\^6 cells/m\^2 x 2) to evaluate the safety of the T cells primed against PRAME pepmix, and then SSX pepmix, and then MAGE A4 pepmix, and then NY-ESO pepmix, and then SURVIVIN pepmix.

0 / 14Eligibility criteria met