78 Participants Needed

ADI-001 for Non-Hodgkin's Lymphoma

(GLEAN-1 Trial)

Recruiting at 11 trial locations
RL
DM
RL
AM
Overseen ByAdicet Medical Director
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: Adicet Therapeutics
Must be taking: Anti CD20 antibody
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

This is a Phase 1 dose escalation study following a 3+3 study design. The purpose of this study is to evaluate the safety and efficacy of ADI-001 in patients with B cell malignancies.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you are on treatments like gene therapy or certain cell therapies, you may need to wait a few weeks before joining the study.

What data supports the effectiveness of the treatment ADI-001 for Non-Hodgkin's Lymphoma?

Research on similar CAR T cell therapies, like those targeting CD19, shows they can be very effective in treating certain types of blood cancers, including some forms of lymphoma. These therapies have transformed outcomes for patients who did not respond to other treatments, suggesting that ADI-001, which targets CD20, might also be promising for Non-Hodgkin's Lymphoma.12345

What safety information is available for ADI-001 or similar CAR T-cell therapies?

CAR T-cell therapies, like ADI-001, have shown potential in treating certain lymphomas but can have serious side effects. These include cytokine release syndrome (a severe immune reaction) and neurotoxicity (nerve damage). While these treatments are promising, managing these side effects is crucial.16789

What makes the drug ADI-001 unique for treating Non-Hodgkin's Lymphoma?

ADI-001 is a novel treatment that uses genetically modified immune cells called CAR-T cells, specifically targeting the CD20 protein on cancer cells, which is different from traditional chemotherapy or radiation therapies. This approach harnesses the body's own immune system to fight the cancer more precisely.1011121314

Research Team

AM

Adicet Medical Director

Principal Investigator

Adicet Bio

Eligibility Criteria

Adults with certain B cell malignancies who've had at least two prior treatments, including anti-CD20 antibody therapies. They must have measurable disease, be in good physical condition (ECOG PS of 0 or 1), and not pregnant or breastfeeding. Participants need to use effective birth control and can't join if they've had CNS lymphoma, recent unrelated cancers, gene therapy within six weeks, radiation within four weeks (except palliative), stem cell transplant within six weeks, or allogeneic transplant within three months.

Inclusion Criteria

My B cell cancer has returned or didn't respond to treatment.
I am 18 years old or older.
I am fully active or can carry out light work.
See 5 more

Exclusion Criteria

Opportunistic infections
I am willing to participate in long-term follow-up for safety monitoring.
I have or had lymphoma in my brain or spinal cord.
See 9 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Participants receive ascending doses of ADI-001 to determine the maximum tolerated dose (MTD) or maximum assessed dose (MAD)

4 weeks
Multiple visits for dose administration and monitoring

Dose Extension

Participants receive multiple doses of ADI-001 at the MAD/MTD to evaluate safety

4 weeks
Multiple visits for dose administration and monitoring

Dose Expansion

Participants receive ADI-001 at the MTD/MAD to confirm the recommended phase 2 dose

12 months
Regular visits for dose administration and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months
Regular follow-up visits

Treatment Details

Interventions

  • ADI-001
Trial OverviewThe trial is testing ADI-001 combined with Fludarabine and Cyclophosphamide in patients with various types of B-cell lymphomas. It's a Phase 1 study using a '3+3' design to find the safest dose that also works effectively against the cancer.
Participant Groups
3Treatment groups
Experimental Treatment
Group I: ADI-001 Dose ExtensionExperimental Treatment3 Interventions
ADI-001 is administered via infusion at MAD/MTD to evaluate the safety of multiple doses (Part 1b).
Group II: ADI-001 Dose ExpansionExperimental Treatment3 Interventions
Dose Expansion ADI-001 is administered via infusion at the MTD/MAD to confirm recommended phase 2 dose (Part 2).
Group III: ADI-001 Dose EscalationExperimental Treatment3 Interventions
ADI-001 is administered via infusion with ascending dose levels as a single dose to determine the maximum tolerated dose (MTD) or maximum assessed dose (MAD) of ADI-001 (Part 1a).

Find a Clinic Near You

Who Is Running the Clinical Trial?

Adicet Therapeutics

Lead Sponsor

Trials
4
Recruited
370+

Adicet Bio, Inc

Lead Sponsor

Trials
3
Recruited
310+

Findings from Research

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]
In a study of 33 diffuse large B cell lymphoma (DLBCL) patients, low levels of differentiated CD3+CD27-CD28- T cells before CART cell therapy were found to be a strong predictor of overall response and complete remission, suggesting their potential as a biomarker for treatment efficacy.
Despite having similar cytotoxic capabilities, CD3+CD8+ T cells were more effective than CD3+CD4+ T cells in killing CD19+ target cells, highlighting the importance of T cell type in the effectiveness of CART cell therapy.
The frequency of differentiated CD3+CD27-CD28- T cells predicts response to CART cell therapy in diffuse large B-cell lymphoma.Worel, N., Grabmeier-Pfistershammer, K., Kratzer, B., et al.[2023]
CAR T cell therapy targeting CD19 has shown remarkable efficacy, achieving complete remission in up to 90% of patients with relapsed or refractory B-cell acute lymphoblastic leukemia (B-ALL), compared to a 30% response rate with traditional chemotherapy.
The therapy involves genetically modifying T cells to express a chimeric antigen receptor, allowing them to effectively target and eliminate cancer cells, although it is important to note that there are unique toxicities associated with this treatment that require careful management.
CD19-Targeted CAR T cells as novel cancer immunotherapy for relapsed or refractory B-cell acute lymphoblastic leukemia.Davila, ML., Brentjens, RJ.[2023]

References

Real-World Treatment Patterns After CD19-Directed CAR T Cell Therapy Among Patients with Diffuse Large B Cell Lymphoma. [2022]
The frequency of differentiated CD3+CD27-CD28- T cells predicts response to CART cell therapy in diffuse large B-cell lymphoma. [2023]
CD19-Targeted CAR T cells as novel cancer immunotherapy for relapsed or refractory B-cell acute lymphoblastic leukemia. [2023]
Adapter CAR T Cell Therapy for the Treatment of B-Lineage Lymphomas. [2022]
[CAR-T cells in lymphomas: Current and evolving role]. [2021]
CAR T-cell therapy for B-cell lymphomas: clinical trial results of available products. [2020]
Biology and clinical application of CAR T cells for B cell malignancies. [2023]
Chimeric antigen receptor T-cell therapies for lymphoma. [2022]
Recent Advances in CAR-T Cell Therapy for Non-Hodgkin Lymphoma. [2020]
10.United Statespubmed.ncbi.nlm.nih.gov
Angioimmunoblastic T cell lymphoma is derived from mature T-helper cells with varying expression and loss of detectable CD4. [2017]
11.United Statespubmed.ncbi.nlm.nih.gov
Angioimmunoblastic T-cell lymphoma: the many-faced lymphoma. [2022]
12.United Statespubmed.ncbi.nlm.nih.gov
Gene expression analysis of angioimmunoblastic lymphoma indicates derivation from T follicular helper cells and vascular endothelial growth factor deregulation. [2007]
Spontaneous remission of angioimmunoblastic T-cell lymphoma in a child with ataxia-telangiectasia: a case report. [2023]
[Clinicopathological analysis of 64 case of angioimmunoblastic T-cell lymphoma]. [2014]