MB-CART19.1 Cellular Therapy for Brain Lymphoma

Overseen By Ivan Kotchetkov, MD

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Memorial Sloan Kettering Cancer Center

Must be taking: Methotrexate

Must not be taking: Immune checkpoint inhibitors

Disqualifiers: Active systemic lymphoma, Autoimmune disease, HIV, Hepatitis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

12 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if MB-CART19.1, a type of cellular therapy, is a safe and effective treatment for central nervous system lymphoma, a cancer affecting the brain and spinal cord. Researchers will test various doses to identify the highest safe dose. The trial seeks individuals with a specific type of brain lymphoma who have not responded to other treatments, particularly if their condition has recently worsened. Participants must be able to undergo certain medical procedures, such as MRI scans and lumbar punctures. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new therapy.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop all current medications, but you must be off certain cancer treatments for a specific time before starting the study. Herbal supplements are not allowed, and corticosteroids must be stable or decreasing if used.

Is there any evidence suggesting that MB-CART19.1 is likely to be safe for humans?

Research has shown that treatments like MB-CART19.1, used for central nervous system lymphoma (CNSL), are generally safe, with most patients experiencing only mild side effects. However, MB-CART19.1 remains under investigation in a trial to determine the safest dose. Researchers continue to explore all its safety aspects. In the study, participants receive varying doses to identify the highest dose that results in only mild side effects. This careful testing ensures the treatment is as safe as possible for prospective trial participants. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for brain lymphoma, which often involve chemotherapy and radiation, MB-CART19.1 operates through a groundbreaking approach called CAR-T cell therapy. This method modifies a patient's own T cells to recognize and attack cancer cells by targeting the CD19 protein, a marker found on many lymphoma cells. Researchers are excited about this treatment because it offers a highly personalized attack on cancer, potentially leading to more effective results with fewer side effects than traditional therapies. Additionally, MB-CART19.1 involves genetic modification of T cells, which may enhance their persistence and efficacy in targeting cancer cells, offering hope for improved patient outcomes.

What evidence suggests that MB-CART19.1 might be an effective treatment for CNSL?

Research has shown that MB-CART19.1, a type of CAR-T cell therapy, offers promising results for treating central nervous system lymphoma (CNSL). One study found that 65% of patients achieved a complete response, with no signs of cancer, within the first 100 days after treatment. This therapy modifies a patient's T cells, a type of immune cell, to better locate and destroy cancer cells. Real-world data for similar treatments also support its effectiveness, showing comparable results in both primary and secondary CNS lymphoma cases. These findings suggest that MB-CART19.1 could be an effective treatment option for those with CNSL. ^{1 6 7 8 9}

Who Is on the Research Team?

Ivan Kotchetkov, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

This trial is for individuals with central nervous system lymphoma (CNSL) who have experienced a relapse. Participants should be suitable for cellular therapy and meet specific health criteria not detailed here.

Inclusion Criteria

Must be able to tolerate both MRI and CT scans

My oxygen levels are 90% or higher without extra oxygen.

I can undergo spinal taps or Ommaya reservoir procedures.

Exclusion Criteria

Patients with HIV

Use of herbal supplements are not allowed on study

I do not have any uncontrolled infections.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Leukapheresis and T Cell Preparation

Participants undergo leukapheresis for mononuclear cell collection, followed by T cell enrichment, activation, and genetic modification

2-3 weeks

Conditioning Chemotherapy

Participants receive conditioning chemotherapy prior to T cell infusion

1 week

Treatment

Modified T cell infusions are administered 2-7 days following completion of conditioning chemotherapy

4 weeks

Multiple visits for infusion and monitoring

Follow-up

Participants are monitored for safety and effectiveness, including serial sampling of blood and CSF

1 year

What Are the Treatments Tested in This Trial?

Interventions

• MB-CART19.1

Trial Overview The study is testing the safety and effectiveness of MB-CART19.1, a type of cellular therapy, in treating CNSL. It aims to determine the highest dose that can be administered with acceptable side effects.

How Is the Trial Designed?

Group I: MB-CART19.1 Cellular Therapy Experimental Treatment 1 Intervention

Following enrollment, patients will undergo leukapheresis of peripheral blood for mononuclear cell collection, followed by further T cell enrichment, activation and genetic modification using a lentiviral vector encoding a CD19 targeted CAR. These T cells will be expanded and after the appropriate number of cells is generated, the modified T cells may be infused fresh or frozen for later use according to standard operating procedures. Modified T cell infusions will be administered 2-7 days following completion of the conditioning chemotherapy. Serial sampling of blood and cerebrospinal fluid (CSF) will be performed following treatment to assess toxicity, therapeutic effects, and survival of the genetically modified T cells.

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

Miltenyi Biomedicine GmbH

Industry Sponsor

Trials

38

Recruited

1,700+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40589238/

Outcomes of CD19 CAR-T therapy in central nervous system ... At day 100 post CAR-T infusion, 65% of patients attained a complete response as their best response in both systemic and central nervous system compartments.

2. haematologica.org haematologica.org/article/view/haematol.2024.285613

Outcomes of patients with primary central nervous system ... While our results appear better than those published in secondary CNS lymphoma following CAR T-cell therapy where the 1-year PFS and OS were 16% ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT07137494

NCT07137494 | A Study of MB-CART19.1 Cellular Therapy ... This study will test whether MB-CART19.1 is a safe and effective treatment for central nervous system lymphoma (CNSL). This study will test ...

4. ashpublications.org ashpublications.org/bloodadvances/article/7/18/5316/496863/Real-world-results-of-CAR-T-cell-therapy-for-large

Real-world results of CAR T-cell therapy for large B-cell ... A recent meta-analysis including 128 patients reported safety and efficacy of CAR-T in secondary (n = 98) and primary (n = 30) CNS lymphoma similar to outcomes ...

5. ovid.com ovid.com/journals/bjha/fulltext/10.1111/bjh.20234~outcomes-of-cd19-cart-therapy-in-central-nervous-system

Outcomes of CD19 CAR‐T therapy in central nervous... At day 100 post CAR‐T infusion, 38 of 52 evaluable patients (73%) achieved a best overall response, with 34 (65%) attaining a CR as best response in both the ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8814680/

CAR T-cell therapy in primary central nervous system lymphoma Nonetheless, recent evidence has shown an acceptable safety profile and some activity of anti-CD19 CAR T-cell treatment of secondary CNS lymphoma (sCNSL).

7. withpower.com withpower.com/trial/phase-1-recurrence-7-2025-aafb2

MB-CART19.1 Cellular Therapy for Brain Lymphoma This study will test whether MB-CART19.1 is a safe and effective treatment for central nervous system lymphoma (CNSL). This study will test different doses ...

8. mskcc.org mskcc.org/cancer-care/clinical-trials/25-066

A Phase 1 Study of MB-CART19.1 Cellular Therapy for ... Researchers are finding the best dose of MB-CART19.1 immunotherapy in people with lymphoma. The people in this study have central nervous system lymphoma (CNSL) ...

9. vjhemonc.com vjhemonc.com/subject/cns-lymphoma/

CNS Lymphoma The CNS Lymphoma Channel provides insightful perspectives on the latest trial updates and real-world data in CNS lymphoma.