6 Participants Needed

Radioimmunotherapy + CAR T-cell Therapy for Acute Lymphoblastic Leukemia and Non-Hodgkin's Lymphoma

Recruiting at 6 trial locations
MG
NP
Overseen ByNeeta Pandit-Taskar, MD
Age: 18+
Sex: Any
Trial Phase: Phase < 1
Sponsor: Memorial Sloan Kettering Cancer Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This is a pilot study; patients will receive 131-I apamistamab prior to CAR T-cell infusion in order to determine the maximum tolerated dose of 131-I apamistamab is exceeded at 75 mCi, and if so, to assess the safety of a step-down dose of 50 mCi.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss your specific medications with the trial team to get a clear answer.

Is the combination of Radioimmunotherapy and CAR T-cell Therapy safe for humans?

CAR T-cell therapy, which is part of the treatment, can cause a side effect called cytokine release syndrome (CRS), leading to symptoms like fever and low blood pressure. However, this side effect is usually manageable with medications like tocilizumab. In trials, CAR T-cell therapy targeting CD19 and CD22 showed a favorable safety profile with no severe CRS or neurotoxicity reported.12345

What makes the Radioimmunotherapy + CAR T-cell Therapy unique for treating Acute Lymphoblastic Leukemia and Non-Hodgkin's Lymphoma?

This treatment is unique because it combines radioimmunotherapy, which uses radioactive substances to target cancer cells, with CAR T-cell therapy, a type of immunotherapy that modifies a patient's own immune cells to better recognize and attack cancer cells. This dual approach aims to enhance the effectiveness of treatment by using two different mechanisms to target and destroy cancer cells.45678

What data supports the effectiveness of the treatment Radioimmunotherapy + CAR T-cell Therapy for Acute Lymphoblastic Leukemia and Non-Hodgkin's Lymphoma?

Research shows that CAR T-cell therapy, which is part of this treatment, has led to high rates of complete remission in patients with relapsed or difficult-to-treat acute lymphoblastic leukemia (ALL), with some studies reporting remission rates as high as 90%.59101112

Who Is on the Research Team?

MB

Mark B Geyer, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

Adults with relapsed or refractory B-cell acute lymphoblastic leukemia or diffuse large B-cell lymphoma, who have tried and not responded to previous treatments. They must have a certain level of organ function, no severe heart conditions, and cannot be pregnant. Those with active infections or other serious health issues are excluded.

Inclusion Criteria

I have B-cell acute lymphoblastic leukemia or chronic myeloid leukemia in blast crisis.
Absolute neutrophil count ≥0.5k/µL,
I had treatment for my cancer relapse but don't need a recent test to join the study for leukapheresis. I need proof of cancer for the next treatment phase.
See 22 more

Exclusion Criteria

I have significant difficulty in performing daily activities.
I have a severe heart condition with very low heart pump function.
Have current or prior positive test results for human immunodeficiency virus (HIV) or hepatitis B (HBV) or C (HCV), with the following exceptions:
See 15 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation

Participants receive 131-I apamistamab to determine the maximum tolerated dose

1 week

Treatment

Participants receive CD19-targeted CAR T-cell therapy following 131-I apamistamab

1 week

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • 131-I Apamistamab
  • CAR T-cell
Trial Overview The trial is testing the combination of a radioactive antibody called 131-I apamistamab followed by CAR T-cell therapy in patients with specific types of blood cancer. The goal is to find the highest dose that patients can tolerate without too many side effects.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: B-Cell Acute Lymphoblastic Leukemia/Diffuse Large B-Cell LymExperimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials
1,998
Recruited
602,000+

Actinium Pharmaceuticals

Industry Sponsor

Trials
8
Recruited
290+

Published Research Related to This Trial

Immunotherapeutic strategies targeting specific surface antigens on acute lymphoblastic leukemia (ALL) cells are being explored as novel treatment options to improve poor outcomes in adult patients.
The review highlights four major classes of antibody therapies, including naked antibodies, immunoconjugates, BiTE therapy, and CAR T-cell therapy, and discusses their potential integration into current treatment protocols for ALL based on preclinical and clinical data.
Future of Therapy in Acute Lymphoblastic Leukemia (ALL)--Potential Role of Immune-Based Therapies.Kebriaei, P., Poon, ML.[2018]
In a phase II trial involving 225 patients aged 20 and under, coadministration of CD19- and CD22-CAR T cells resulted in a remarkable 99% complete remission rate for those with refractory B-acute lymphoblastic leukemia, with a 12-month event-free survival (EFS) rate of 73.5%.
While the treatment was effective, it was associated with significant side effects, including cytokine release syndrome in 88% of patients and CAR T-cell neurotoxicity in 20.9%, leading to three deaths, highlighting the need for careful monitoring during therapy.
Coadministration of CD19- and CD22-Directed Chimeric Antigen Receptor T-Cell Therapy in Childhood B-Cell Acute Lymphoblastic Leukemia: A Single-Arm, Multicenter, Phase II Trial.Wang, T., Tang, Y., Cai, J., et al.[2023]
In a phase 1 trial of 53 adults with relapsed B-cell acute lymphoblastic leukemia, 83% achieved complete remission after receiving CD19-specific CAR T cells, indicating high initial efficacy.
Patients with a low disease burden before treatment experienced significantly longer overall survival (20.1 months) and fewer severe side effects, such as cytokine release syndrome, compared to those with a higher disease burden.
Long-Term Follow-up of CD19 CAR Therapy in Acute Lymphoblastic Leukemia.Park, JH., Rivière, I., Gonen, M., et al.[2023]

Citations

Future of Therapy in Acute Lymphoblastic Leukemia (ALL)--Potential Role of Immune-Based Therapies. [2018]
Coadministration of CD19- and CD22-Directed Chimeric Antigen Receptor T-Cell Therapy in Childhood B-Cell Acute Lymphoblastic Leukemia: A Single-Arm, Multicenter, Phase II Trial. [2023]
Long-Term Follow-up of CD19 CAR Therapy in Acute Lymphoblastic Leukemia. [2023]
[Chimeric antigen receptors T cells in treatment of a relapsed pediatric acute lymphoblastic leukemia, relapse after allogenetic hematopoietic stem cell transplantation: case report and review of literature review]. [2020]
Chimeric antigen receptor T-cell therapy for ALL. [2020]
Cytokine release syndrome with novel therapeutics for acute lymphoblastic leukemia. [2022]
Cytokine release syndrome: Who is at risk and how to treat. [2022]
Targeting CD19-CD22 Aids Younger Patients with ALL. [2021]
CAR T cells with dual targeting of CD19 and CD22 in pediatric and young adult patients with relapsed or refractory B cell acute lymphoblastic leukemia: a phase 1 trial. [2022]
The emerging scenario of immunotherapy for T-cell Acute Lymphoblastic Leukemia: advances, challenges and future perspectives. [2023]
Emerging role of immunotherapy in precursor B-cell acute lymphoblastic leukemia. [2018]
12.United Statespubmed.ncbi.nlm.nih.gov
Effectiveness and safety of CD22 and CD19 dual-targeting chimeric antigen receptor T-cell therapy in patients with relapsed or refractory B-cell malignancies: A meta-analysis. [2023]
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