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CAR T-cell Therapy

CD19 CAR-T Cells for Leukemia and Lymphoma (MULTIPRAT Trial)

Phase 1

Waitlist Available

Led By Carlos A 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

Any patient regardless of sex or age with CD19+ B-CLL or NHL undergoing allogeneic HSCT (Group B)

Available allogeneic CD19CAR transduced tri-virus-specific cytotoxic T lymphocytes with greater than or equal to15% expression of CD19CAR determined by flow-cytometry and greater than 10% killing of one or more viral antigen pulsed targets in a cytotoxicity assay at an effector:target ratio of 20:1

Must not have

Currently taking corticosteroids for therapy of GVHD

Evidence of graft versus host disease >grade II

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 15 years

Awards & highlights

All Individual Drugs Already Approved

Approved for 10 Other Conditions

No Placebo-Only Group

Summary

This trial is testing a new treatment for leukemia and lymphoma that uses a combination of two types of blood cells, T cells and antibodies. The hope is that this will be a more effective treatment with fewer side effects than current treatments.

Who is the study for?

This trial is for patients of any age and sex with CD19+ B-ALL or B-CLL/NHL undergoing a bone marrow transplant. They must have a life expectancy of at least 6 weeks, be able to consent, and use effective birth control post-treatment. Excluded are those with severe allergies to murine proteins, active GVHD above grade II, pregnancy, lactation, or severe infections.

What is being tested?

The study tests T cells modified with an anti-CD19 chimeric receptor (CD19CAR) against leukemia/lymphoma post-transplant. It aims to find the highest safe dose of these T cells while assessing side effects and their longevity in preventing relapse and infections.

What are the potential side effects?

Potential side effects include reactions related to immune response such as inflammation in various organs due to the modified T cells' activity. There may also be typical infusion-related reactions like fever or chills from Benadryl/Tylenol administration.

Eligibility Criteria

Inclusion Criteria

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

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I have B-CLL or NHL with CD19+ and am getting a stem cell transplant from a donor.

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My treatment involves a specific immune cell therapy targeting CD19.

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I do not have leukemia or lymphoma after my stem cell transplant.

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My liver and kidney functions are within the required limits, and my hemoglobin is above 8.0.

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I am able to live with some level of independence.

Exclusion Criteria

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

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I am currently on corticosteroids for graft-versus-host disease.

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I have severe symptoms from a transplant complication.

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I am currently suffering from a severe infection.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 15 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 15 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 15 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

Number of dose limiting toxicities

Secondary study objectives

Frequency of CD19+ B-Cells post HSCT expressing gene-modified CTLs

Frequency of T-cells expressing gene-modified CTLs.

Tumor response to gene modified CTL on measurable disease.

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Approved for 10 Other Conditions

This treatment demonstrated efficacy for 10 other conditions.

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: Group B without diseaseExperimental Treatment2 Interventions

CD19+ B cell CLL or NHL undergoing allogeneic HSCT, without detectable disease post-HSCT Patients will receive CD19CAR/virus specific T cells - Dose Level 1: 1.5 x 10\^7/m2 Patients will be evaluated in the clinic and a single dose of CTL will be administered from day +30 post-HSCT. Patients may be premedicated with Benadryl and Tylenol before receiving the injection of cells.

Group II: Group B with diseaseExperimental Treatment2 Interventions

CD19+ B cell CLL or NHL undergoing allogeneic HSCT, with minimal residual disease or relapse post-HSCT Patients will receive one of the following dose levels of CD19CAR/virus specific T cells: Dose Level 1: 1.5 x 10\^7/m2 Dose Level 2: 4.5 x 10\^7/m2 Dose Level 3: 1.2 x 10\^8/m2 Patients will be evaluated in the clinic and a single dose of CTL will be administered from day +30 post-HSCT. Patients may be premedicated with Benadryl and Tylenol before receiving the injection of cells. If patients with relapse have a partial response or have stable disease they will be eligible to receive up to 6 further doses of CTLs, each of which will consist of the same number or less than as their first injection.

Group III: Group A without diseaseExperimental Treatment2 Interventions

CD19+ B-ALL undergoing allogeneic HSCT, without detectable disease post-HSCT. Patients will receive CD19CAR/virus specific T cells - Dose Level 1: 1.5 x 10\^7/m2 Patients will be evaluated in the clinic and a single dose of CTL will be administered from day +30 post-HSCT. Patients may be premedicated with Benadryl and Tylenol before receiving the injection of cells.

Group IV: Group A with diseaseExperimental Treatment2 Interventions

CD19+ B-ALL undergoing allogeneic HSCT, with minimal residual disease or relapse post-HSCT Patients will receive one of the following dose levels of CD19CAR/virus specific T cells: Dose Level 1: 1.5 x 10\^7/m2 Dose Level 2: 4.5 x 10\^7/m2 Dose Level 3: 1.2 x 10\^8/m2 Patients will be evaluated in the clinic and a single dose of CTL will be administered from day +30 post-HSCT. Patients may be premedicated with Benadryl and Tylenol before receiving the injection of cells. If patients with relapse have a partial response or have stable disease they will be eligible to receive up to 6 further doses of CTLs, each of which will consist of the same number or less than as their first injection.

0 / 8Eligibility criteria met