JNJ-90009530 for B-Cell Lymphoma

Recruiting at 12 trial locations

Overseen By Study Contact

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Cellular Biomedicine Group, Inc.

Must be taking: Anti-CD20 agents

Disqualifiers: HHV 8-positive DLBCL, prior allogeneic HSCT, uncontrolled infections, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 24 months

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment called JNJ-90009530 (also known as C-CAR066, a type of chimeric antigen receptor T cell therapy) for individuals with B-cell lymphoma. The main goals are to determine a safe dose of the drug and assess its effectiveness and duration of benefit for patients. The study seeks participants who have experienced lymphoma recurrence or resistance to other treatments, particularly those who have tried at least two different treatment plans. The trial aims to assist those facing frequent setbacks in managing their lymphoma. As a Phase 1 trial, this 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 information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that JNJ-90009530 is likely to be safe for humans?

Studies have shown that C-CAR066, a new type of CAR-T therapy, is generally safe. CAR-T therapy modifies a patient's immune cells to enhance their ability to fight cancer. In follow-up research, patients with a type of B-cell lymphoma who received C-CAR066 experienced strong and lasting improvements. Importantly, the treatment was safe, with few serious side effects reported.

These findings suggest that C-CAR066 is usually well-tolerated. However, since the current trial is in an early stage, further research is needed to confirm these results. Patients should always consult healthcare providers to understand the potential risks and benefits. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about C-CAR066 for B-cell lymphoma because it offers a novel approach compared to traditional treatments like chemotherapy and monoclonal antibodies. C-CAR066 is a type of CAR-T cell therapy, which involves reprogramming a patient's own T-cells to better recognize and attack cancer cells. This personalized approach not only targets the cancer more precisely, potentially leading to better outcomes, but it also minimizes damage to healthy cells, reducing some of the harsh side effects often seen with conventional treatments.

What evidence suggests that JNJ-90009530 might be an effective treatment for B-Cell Lymphoma?

Research has shown that C-CAR066, the investigational treatment in this trial, holds promise for treating B-cell lymphoma, particularly in patients unresponsive to other treatments. Studies indicate that C-CAR066, which targets the CD20 protein on cancer cells, can lead to strong and lasting improvements in patients with relapsed or hard-to-treat large B-cell lymphoma. Patients who did not benefit from other therapies, including those targeting a different protein (CD19), experienced significant improvements. Additionally, C-CAR066 has generally been well-tolerated, indicating a good safety record. Overall, early results are encouraging for those considering this treatment option. ^{1 2 6 7 8}

Who Is on the Research Team?

Janssen Research & Development, LLC Clinical Trial

Principal Investigator

Janssen Research & Development, LLC

Are You a Good Fit for This Trial?

This trial is for adults over 18 with B-Cell Non-Hodgkin Lymphoma that's come back or didn't respond after at least two treatments, and relapsed within a year of the last treatment. Participants must have a certain level of physical fitness (ECOG status 0 or 1) and their tumors must test positive for CD20.

Inclusion Criteria

My cancer has returned or didn't respond to treatment.

Measurable disease as defined by Lugano 2014 classification

My tumor is CD20 positive.

Exclusion Criteria

My cancer has spread to my brain or spinal cord.

I haven't had a serious heart condition or stroke in the last 6 months.

I have been diagnosed with a specific type of lymphoma linked to the HHV-8 virus.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive JNJ-90009530, an autologous anti-CD20 CAR-T cell therapy, to determine a safe and well-tolerated dose and assess response

24 months

Follow-up

Participants are monitored for safety, tolerability, and effectiveness, including adverse events, overall survival, and progression-free survival

24 months

What Are the Treatments Tested in This Trial?

Interventions

• C-CAR066

Trial Overview The study tests JNJ-90009530 to find a safe dose that patients can tolerate well, see if it helps reduce cancer symptoms, and how long any benefits last. It's conducted across multiple centers where participants receive this experimental drug.

How Is the Trial Designed?

Group I: JNJ-90009530 Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Cellular Biomedicine Group, Inc.

Lead Sponsor

Trials

3

Recruited

270+

Janssen Research & Development, LLC

Lead Sponsor

Trials

1,022

Recruited

6,408,000+

Joaquin Duato

Janssen Research & Development, LLC

Chief Executive Officer since 2022

MBA from ESADE, Master of International Management from Thunderbird School of Global Management

Dr. Jijo James, MD

Janssen Research & Development, LLC

Chief Medical Officer since 2014

MD from St. Johns Medical College, MPH from Columbia University

Mayo Clinic

Collaborator

Trials

3,427

Recruited

3,221,000+

Published Research Related to This Trial

CAR-T-cell therapy has shown significant promise in treating relapsed or refractory B-cell malignancies, such as B-cell non-Hodgkin lymphoma and B-cell acute lymphoblastic leukemia, by targeting specific antigens like CD19 and BCMA.

The review highlights both the efficacy and toxicity of CD19- and BCMA-targeted CAR-T-cell therapies, indicating that while these treatments can be effective, they also come with potential side effects that need to be managed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Chimeric Antigen Receptor-T-Cell Therapy for B-Cell Hematological Malignancies: An Update of the Pivotal Clinical Trial Data. Roex, G., Feys, T., Beguin, Y., et al.[2020]

In a phase I study involving 10 patients with refractory diffuse large B-cell lymphoma (DLBCL), the anti-CD19 CAR T cell therapy (C-CAR011) demonstrated a 50% overall response rate at 12 weeks, indicating promising efficacy for this treatment.

The therapy showed a favorable safety profile, with 90% of patients experiencing cytokine release syndrome but no severe (grade ⩾ 3) cases or neurotoxicity, suggesting it is a safe option for patients with heavily treated DLBCL.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase I study of CBM.CD19 chimeric antigen receptor T cell in the treatment of refractory diffuse large B-cell lymphoma in Chinese patients. Fan, L., Wang, L., Cao, L., et al.[2022]

Adoptive T-cell therapy using anti-CD19 chimeric antigen receptor (CAR)-expressing T cells showed strong effectiveness in eliminating lymphoma cells in a murine model, with complete eradication of normal B cells lasting for at least 143 days after treatment.

The success of the anti-CD19-CAR-transduced T cells in fighting lymphoma was significantly enhanced by pre-treatment irradiation of the mice, and these CAR T cells outperformed the original anti-CD19 monoclonal antibody in terms of efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adoptive transfer of syngeneic T cells transduced with a chimeric antigen receptor that recognizes murine CD19 can eradicate lymphoma and normal B cells. Kochenderfer, JN., Yu, Z., Frasheri, D., et al.[2023]

CD19-CAR T cell therapy is feasible and safe for treating children and young adults with refractory B-cell malignancies, with a maximum tolerated dose established at 1×10^6 CAR T cells per kg.

The treatment showed potent anti-leukaemic activity, with all toxicities being fully reversible, including severe cases of cytokine release syndrome in 14% of patients, indicating a manageable safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

T cells expressing CD19 chimeric antigen receptors for acute lymphoblastic leukaemia in children and young adults: a phase 1 dose-escalation trial. Lee, DW., Kochenderfer, JN., Stetler-Stevenson, M., et al.[2022]

CAR T cell therapy has shown high response and remission rates in patients with aggressive B-cell lymphoma, acute lymphoblastic leukemia, and multiple myeloma, particularly in those who have undergone extensive prior treatments.

The article discusses not only the indications for CAR T cell therapy approval but also its clinical implementation and how to manage potential side effects, highlighting its practical application in treating difficult cancers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[CAR-T cell therapy - personalized cellular immunotherapy in 2022]. Niebling, J., Bethge, W., Lengerke, C.[2022]

CAR-T cell therapy targeting the CD19 antigen has significantly changed treatment for patients with relapsed or refractory B cell non-Hodgkin lymphoma, with two FDA-approved products available: axicabtagene ciloleucel and tisagenlecleucel.

The review highlights the clinical outcomes and toxicity profiles of these CAR-T therapies, indicating their effectiveness across major B cell NHL subtypes, while also discussing new CAR-T constructs currently being researched.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Chimeric antigen receptor modified T cell therapy in B cell non-Hodgkin lymphomas. Levin, A., Shah, NN.[2021]

CAR-T cell therapy has shown promising efficacy in treating relapsed or refractory B cell malignancies, particularly in B cell acute lymphoblastic leukemia (B-ALL), by enabling T cells to target tumor-associated antigens without relying on MHC molecules.

There is ongoing research to expand the use of CAR-T therapy beyond blood cancers to solid tumors, while addressing challenges related to enhancing anti-tumor activity and ensuring patient safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Current status and perspectives of chimeric antigen receptor modified T cells for cancer treatment. Wang, Z., Guo, Y., Han, W.[2023]

CAR T-cells are engineered T-cells that target the CD19 antigen, showing promising initial results in treating various B-cell malignancies, including acute lymphocytic leukaemia and chronic lymphocytic leukaemia.

While the treatment shows potential, there are significant differences in patient responses and notable side effects that require careful management, highlighting the need for personalized approaches in therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

T-cells fighting B-cell lymphoproliferative malignancies: the emerging field of CD19 CAR T-cell therapy. Heijink, DM., Kater, AP., Hazenberg, MD., et al.[2017]

CAR T cell therapy, particularly targeting B cell maturation antigen (BCMA), has shown promising efficacy in early clinical trials for treating multiple myeloma, indicating its potential as a new treatment option.

Recent research has also demonstrated that CAR T cells targeting activated integrin β7 can effectively eliminate multiple myeloma cells, including specific B cell types, and preparations for a clinical trial are underway.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Chimeric antigen receptor T cell therapy for multiple myeloma. Hasegawa, K., Hosen, N.[2020]

CAR-T cell therapy has shown remarkable efficacy in treating B cell malignancies, including leukemia, lymphoma, and multiple myeloma, with high response rates, but it comes with significant safety concerns.

The most serious side effects of CAR-T therapy are cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS), which require supportive care and specific treatments like tocilizumab and steroids to manage.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

CAR-T Cell Therapy: the Efficacy and Toxicity Balance. Chohan, KL., Siegler, EL., Kenderian, SS.[2023]

Anti-CD19-directed CAR T cell therapy has shown significant efficacy in treating relapsed or refractory B-cell malignancies, leading to the approval of tisagenlecleucel (Kymriah) for B-ALL in 2018 and for aggressive B-cell lymphoma shortly thereafter.

The review highlights ongoing research into resistance mechanisms and the exploration of new target antigens, indicating a continued effort to improve treatment outcomes for patients with CD19 positive B-cell lymphomas.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[CAR T-cell therapy for malignant B-cell lymphoma : A new treatment paradigm]. Balke-Want, H., Borchmann, P.[2021]

Adoptive transfer of CAR-modified T cells targeting B-cell malignancies shows significant anti-tumor efficacy in preclinical models, suggesting a promising alternative to traditional HSCT for chemotherapy-resistant cases.

Currently, there are 12 open clinical trials and one completed trial investigating the use of CAR T cells targeting CD19 or CD20 antigens, indicating a strong move towards clinical application of this innovative therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adoptive immunotherapy for B-cell malignancies with autologous chimeric antigen receptor modified tumor targeted T cells. Park, JH., Brentjens, RJ.[2022]

The study developed a CAR (CD4CAR) that enables CD8+ T cells to target and eliminate CD4+ T-cell lymphomas, showing effectiveness in both laboratory and patient-derived samples.

In mouse models of aggressive T-cell lymphoma, CD4CAR T cells not only suppressed tumor growth but also significantly extended survival, suggesting their potential as a new treatment option for patients with peripheral T-cell lymphomas.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preclinical targeting of human T-cell malignancies using CD4-specific chimeric antigen receptor (CAR)-engineered T cells. Pinz, K., Liu, H., Golightly, M., et al.[2018]

Citations

1. ashpublications.org ashpublications.org/blood/article/142/Supplement%201/2115/504061/Two-Year-Follow-up-Results-of-C-CAR066-a-Novel

Two-Year Follow-up Results of C-CAR066, a Novel Anti-CD20 ... C-CAR066 is a novel 2nd generation CAR-T therapy targeting CD20 antigen. We previously reported that C-CAR066 had shown a favorable safety profile and ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S0006497123087189

Two-Year Follow-up Results of C-CAR066, a Novel Anti- ... Longer term follow-up demonstrated that C-CAR066 can produce a deep and durable response with a favorable safety profile in pts with r/r LBCL who failed prior ...

3. researchgate.net researchgate.net/publication/384504392_C-CAR066_a_novel_fully_human_anti-CD20_CAR-T_therapy_for_relapsed_or_refractory_large_B-cell_lymphoma_after_failure_of_anti-CD19_CAR-T_therapy_A_phase_I_clinical_study

(PDF) C‐CAR066, a novel fully human anti‐CD20 CAR‐T ... C‐CAR066, a novel fully human anti‐CD20 CAR‐T therapy for relapsed or refractory large B‐cell lymphoma after failure of anti‐CD19 CAR‐T therapy: A phase I ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT03576807?tab=table

The Clinical Research of Anti-CD20 CAR-T Cells in ... Patients diagnosed with B-cell relapse/refractory lymphoma have no effective treatment option. They have been treated for more than 2 years after autologous ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12096171/

Case Report: Bispecific CD20/CD30-targeted chimeric ... We report that a patient with bulky transformed follicular lymphoma was successfully treated with CD20/CD30-directed CAR-T cells.

6. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/full/10.1002/ajh.27488

C‐CAR066, a novel fully human anti‐CD20 CAR‐T therapy ... A novel fully human anti-CD20 CAR-T therapy for relapsed or refractory large B-cell lymphoma after failure of anti-CD19 CAR-T therapy: A phase I clinical study

7. clinicaltrials.gov clinicaltrials.gov/study/NCT06532643

Safety and Efficacy of Anti-CD20/CD30 CAR-T Cells in ... This study is an exploratory clinical trial of a single-center, open-label, single-dose treatment of anti-CD20/CD30-CAR-T cells in subjects with relapsed/ ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5661643/

Long-term safety and efficacy of CART-20 cells in patients ... This paper reports the long-term efficacy and safety of CART-20 cells in patients with r/r CD20 + B-NHL after 5-year follow-up.