160 Participants Needed

CAR T Cell Therapy for Large B-Cell Lymphoma

(ALPHA2 Trial)

Recruiting at 26 trial locations
A
AT
Overseen ByAllogene Therapeutics Inc.
Age: 18+
Sex: Any
Trial Phase: Phase 1 & 2
Sponsor: Allogene Therapeutics
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

Do I need to stop my current medications to join the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, you must not have had systemic anti-cancer therapy within 2 weeks before receiving ALLO-647.

Will I have to stop taking my current medications?

The trial requires that you stop any systemic anti-cancer therapy at least 2 weeks before receiving ALLO-647. The protocol does not specify about other medications, so it's best to discuss with the trial team.

What data supports the idea that CAR T Cell Therapy for Large B-Cell Lymphoma is an effective treatment?

The available research shows that CAR T Cell Therapy is an effective treatment for Large B-Cell Lymphoma. In a study comparing CAR T Cell Therapy to another treatment called alloHCT, patients who received CAR T Cell Therapy had a longer median survival time of 475 days compared to 285 days for those who received alloHCT. Additionally, after receiving the treatment, 68% of CAR T Cell patients were still alive after 12 months, compared to 54% of alloHCT patients. This suggests that CAR T Cell Therapy may be a better option for patients with this type of lymphoma.12345

What data supports the effectiveness of the treatment ALLO-501A for large B-cell lymphoma?

Research shows that CD19-directed CAR T-cell therapy, like ALLO-501A, is a standard treatment for relapsed or refractory large B-cell lymphoma, with outcomes not inferior to other treatments like allogeneic transplantation. Patients receiving CAR T-cell therapy had a median overall survival of 475 days, suggesting it is a viable option for this condition.12345

What safety data is available for CAR T Cell Therapy in treating large B-cell lymphoma?

CAR T Cell Therapy, specifically targeting CD19, has been evaluated for safety in various studies. The therapy is associated with some adverse events, including cytokine release syndrome (33-69%), neurotoxicity (8-33%), and B-cell aplasia (54%). However, the therapy has shown a good safety profile in some trials, with no serious adverse events directly attributed to the treatment and no dose-limiting toxicities reported. The risk of graft-versus-host disease is low, especially with off-the-shelf CAR T-cell therapies. Infectious complications are a concern, and optimal antimicrobial prophylaxis strategies are still being studied.678910

Is CAR T-cell therapy safe for humans?

CAR T-cell therapy, including treatments like ALLO-501A, has been studied for safety in various conditions like acute lymphoblastic leukemia (ALL) and non-Hodgkin lymphoma (NHL). Common side effects include cytokine release syndrome (a reaction causing fever and low blood pressure) and neurotoxicity (nerve damage), but serious adverse events are rare. Overall, it is considered safe with manageable side effects.678910

Is the treatment ALLO-501A a promising treatment for large B-cell lymphoma?

Yes, ALLO-501A, a type of CAR T-cell therapy, is a promising treatment for large B-cell lymphoma. It uses specially modified immune cells to target and fight cancer cells, offering new hope for patients who have not responded to other treatments.311121314

How is the treatment ALLO-501A different from other treatments for large B-cell lymphoma?

ALLO-501A is a type of CAR T-cell therapy that uses specially modified immune cells to target and destroy cancer cells, specifically those with the CD19 marker. Unlike traditional treatments, it involves using donor-derived (allogeneic) T-cells, which can be more readily available than the patient's own cells, potentially offering a quicker treatment option.311121314

What is the purpose of this trial?

This is a single-arm, open label, multicenter Phase 1/2 study evaluating ALLO-501A in adult subjects with R/R LBCL and CLL/SLL. The purpose of the ALPHA2 study is to assess the safety, efficacy, and cell kinetics of ALLO-501A in adults with relapsed or refractory large B-cell lymphoma and assess the safety of ALLO-501A in adults with relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) after a lymphodepletion regimen comprising fludarabine, cyclophosphamide, and ALLO-647.

Eligibility Criteria

Adults with relapsed or refractory large B-cell lymphoma who have tried at least two chemotherapy treatments can join. They should be relatively healthy (ECOG status 0 or 1), not have had certain recent treatments like radiation, and must not have active infections or other cancers treated in the last three years.

Inclusion Criteria

I am fully active or can carry out light work.
My condition did not improve after 2 different chemotherapy treatments.
My blood, kidney, and liver tests are within normal ranges.
See 3 more

Exclusion Criteria

I haven't had any cancer treatments in the last 2 weeks.
I have a thyroid disorder, but it's controlled with stable hormone therapy.
I had a stem cell transplant using my own cells within the last 6 months.
See 6 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Lymphodepletion

Participants receive a lymphodepletion regimen comprising fludarabine, cyclophosphamide, and ALLO-647

1 week

Treatment

Participants receive ALLO-501A, an anti-CD19 allogeneic CAR T cell therapy

4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 60 months

Treatment Details

Interventions

  • ALLO-501A
  • Cyclophosphamide
  • Fludarabine
Trial Overview The ALPHA-2 study is testing ALLO-501A CAR T cells after a prep treatment with fludarabine, cyclophosphamide, and ALLO-647. The goal is to see if this new therapy is safe and effective for patients whose lymphoma has come back or hasn't responded to previous treatments.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: ALLO-501A, ALLO-647Experimental Treatment4 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Allogene Therapeutics

Lead Sponsor

Trials
7
Recruited
810+
Headquarters
South San Francisco, USA
Known For
Allogenic CAR T
Top Products
Cemacabtagene ansegedleucel (cema-cel), ALLO-501, ALLO-501A, ALLO-316

Findings from Research

In a study comparing CD19-directed CAR T-cell treatment and allogeneic hematopoietic cell transplantation (alloHCT) for patients with multiply relapsed/refractory large B-cell lymphoma, CAR T-cell therapy showed a median overall survival of 475 days compared to 285 days for alloHCT, indicating a potential advantage in survival outcomes.
CAR T-cell treatment had significantly lower nonrelapse mortality (3% vs 21%) compared to alloHCT, suggesting it may be a safer option for patients, while overall outcomes were not inferior, supporting the use of CAR T cells as a preferred first-line cellular immunotherapy.
CAR T cells or allogeneic transplantation as standard of care for advanced large B-cell lymphoma: an intent-to-treat comparison.Dreger, P., Dietrich, S., Schubert, ML., et al.[2021]
In a study of 35 patients with relapsed B-cell acute lymphoblastic leukemia after allogeneic stem cell transplantation, 85.7% achieved complete remission after receiving CD19-targeted CAR T cell therapy, indicating high initial efficacy.
However, the long-term outcomes were concerning, with a recurrence rate of 68.3% at 18 months and an overall survival rate of only 30.0%, suggesting that additional treatments may be necessary to improve long-term efficacy.
Long-term follow-up of CD19 chimeric antigen receptor T-cell therapy for relapsed/refractory acute lymphoblastic leukemia after allogeneic hematopoietic stem cell transplantation.Chen, YH., Zhang, X., Cheng, YF., et al.[2021]
In a study of 129 adults with relapsed/refractory diffuse large B cell lymphoma (DLBCL) treated with CD19-directed CAR T therapy, 95.4% were hospitalized during treatment, with a median hospital stay of 17 days, highlighting the intensive care required during this therapy.
The estimated 6-month risk of requiring subsequent treatment after CAR T was 36.2%, indicating a significant chance of treatment failure, and emphasizing the need for effective salvage therapies for DLBCL patients.
Real-World Treatment Patterns After CD19-Directed CAR T Cell Therapy Among Patients with Diffuse Large B Cell Lymphoma.Jalbert, JJ., Wu, N., Chen, CI., et al.[2022]

References

CAR T cells or allogeneic transplantation as standard of care for advanced large B-cell lymphoma: an intent-to-treat comparison. [2021]
Long-term follow-up of CD19 chimeric antigen receptor T-cell therapy for relapsed/refractory acute lymphoblastic leukemia after allogeneic hematopoietic stem cell transplantation. [2021]
Real-World Treatment Patterns After CD19-Directed CAR T Cell Therapy Among Patients with Diffuse Large B Cell Lymphoma. [2022]
Long-Term Follow-Up of CD19-CAR T-Cell Therapy in Children and Young Adults With B-ALL. [2022]
Anti-CD19 Chimeric Antigen Receptor T Cell Therapies: Harnessing the Power of the Immune System to Fight Diffuse Large B Cell Lymphoma. [2020]
Donor-derived and off-the-shelf allogeneic anti-CD19 CAR T-cell therapy for R/R ALL and NHL: A systematic review and meta-analysis. [2022]
Anti-CD 19 and anti-CD 20 CAR-modified T cells for B-cell malignancies: a systematic review and meta-analysis. [2023]
T cells expressing CD19 chimeric antigen receptors for acute lymphoblastic leukaemia in children and young adults: a phase 1 dose-escalation trial. [2022]
Sleeping beauty generated CD19 CAR T-Cell therapy for advanced B-Cell hematological malignancies. [2023]
Infectious complications among CD19 CAR-T cell therapy recipients: A single-center experience. [2023]
The place of allogeneic stem cell transplantation in aggressive B-cell non-Hodgkin lymphoma in the era of CAR-T-cell therapy. [2022]
12.United Statespubmed.ncbi.nlm.nih.gov
CAR T-Cell Therapy for Relapsed/Refractory Aggressive Large B-Cell Lymphoma. [2023]
Chimeric Antigen Receptor-T-Cell Therapy for B-Cell Hematological Malignancies: An Update of the Pivotal Clinical Trial Data. [2020]
T-cells fighting B-cell lymphoproliferative malignancies: the emerging field of CD19 CAR T-cell therapy. [2017]
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