A Multi-Center, Open-Label, Phase 1/2 Clinical Trial to Evaluate the Safety and Anti-Tumor Activity of AB-101 Monotherapy and AB-101 With Immunotherapy in Patients With Relapsed/Refractory Non-Hodgkin Lymphoma of B-Cell Origin.

New NK Cell Therapy Trial for Relapsed/Refractory B-Cell Lymphoma

NCT: NCT04673617 · Status: COMPLETED · Phase: Phase 2 · Sponsor: Artiva Biotherapeutics, Inc. · Started: 2021-03-29 · Est. Completion: 2025-10-06

Plain English Summary

AB-101 as Monotherapy and With Immunotherapy in Patients With Relapsed/Refractory B-Cell Non-Hodgkin Lymphoma is a Phase 2 clinical trial sponsored by Artiva Biotherapeutics, Inc. studying Non Hodgkin Lymphoma. This trial tests a new treatment called AB-101, which uses natural killer (NK) cells, a type of immune cell that fights cancer. It is for adults with B-cell non-Hodgkin lymphoma that has returned or did not respond to previous treatments. Participation involves receiving AB-101 alone or with other standard therapies, with regular health and tumor assessments. Alternative treatments may include chemotherapy, targeted therapy, or other immunotherapies, depending on prior treatments and disease status. The trial aims to enroll 45 participants.

Official Summary

AB-101 is an off-the shelf, allogeneic cell product made of "natural killer" cells, also called NK cells. White blood cells are part of the immune system and NK cells are a type of white blood cell that are known to kill cancer cells. This clinical trial will enroll patients with relapsed/refractory non-Hodgkin lymphoma of B-cell origin and is conducted in two phases. The primary objectives of Phase 1 are as follows: 1) to evaluate the safety of AB-101 given alone or in combination with rituximab (including the DLBCL specific cohort) or in combination with bendamustine and rituximab; 2) to evaluate the potential clinical activity of AB-101 when given in combination with rituximab or in combination with bendamustine and rituximab (combination cohorts only); and 3) to identify the recommended Phase 2 dose (RP2D). The primary objective of Phase 2 is to determine whether AB-101 in combination with rituximab or in combination with bendamustine and rituximab has anti-cancer activity in patients. Patients will be assigned to receive either AB-101 alone as monotherapy, in combination with rituximab (including DLBCL specific cohort) or in combination with bendamustine and rituximab. All patients will receive at least 1 treatment cycle of AB-101, followed by scheduled assessments of overall health and tumor response. Patients receiving AB-101 in combination with rituximab may receive up to 3 additional cycles of treatment. Patients receiving AB-101 in combination with bendamustine and rituximab may receive up to 5 additional cycles of treatment. Patients enrolled into the DLBCL specific cohort receiving AB-101 in combination with rituximab may receive up to 3 cycles of treatment.

Who Can Participate

Here is what you need to know about eligibility for this trial. Adults with a confirmed diagnosis of aggressive B-cell non-Hodgkin lymphoma. Patients must have tried at least two prior treatments, including one with an anti-CD20 antibody, and their cancer has returned or not responded. Individuals with active cancer in the brain or spinal fluid, significant heart or lung problems, or certain autoimmune conditions cannot join. Prior stem cell transplants or certain other cell therapies are generally not allowed unless the patient did not become resistant to them. This trial is studying Non Hodgkin Lymphoma, so participants generally need a confirmed diagnosis.

What They're Measuring

The primary outcome measures assess how safe the new treatment is and how well it shrinks tumors, meaning it will determine if AB-101 is a viable and effective option for patients whose lymphoma has n The specific primary outcome measures are: Phase 1: Safety and tolerability of AB-101 as monotherapy, and in combination with rituximab (including the DLBCL specific cohort) and in combination with bendamustine and rituximab. (From the ICF signature through 13 weeks after last study drug dose.); Phase 1, combination therapy: AB-101 clinical activity, determined by ORR (From baseline disease assessment through end of study participation.); Phase 1, combination therapy: Identify the recommended Phase 2 dose (R2PD) for AB-101. (From ICF signature through 13 weeks after last study drug dose.); Phase 2: Determine the efficacy profile of AB-101 in combination with rituximab or in combination with bendamustine and rituximab when administered to patients with R/R NHL of B-cell origin. (From baseline disease assessment through end of study participation.). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.

About This Phase

This trial is in Phase 2, which tests whether the treatment actually works against the target condition. Phase 2 trials involve 100-300 patients and continue to monitor safety while evaluating effectiveness. This phase often tests different dosages to find the optimal amount. About 33% of Phase 2 drugs advance to Phase 3. If successful, the treatment will move to large-scale Phase 3 trials needed for FDA approval.

Why This Trial Matters

This trial explores a novel cell therapy approach using NK cells, aiming to provide a new treatment option for patients with difficult-to-treat B-cell lymphomas who have exhausted standard therapies. Phase 2 success would typically lead to larger Phase 3 trials needed for regulatory approval. This research targets Non Hodgkin Lymphoma, where improved treatment options are needed.

Investor Insight

This trial targets a significant unmet need in relapsed/refractory lymphoma, a market with substantial patient populations, and represents an investment in the growing field of cell-based immunotherap Phase 2 trials have approximately a 15-20% chance of eventually gaining FDA approval.

Is This Trial Right for Me?

Ask your doctor about the specific treatment combinations being tested and what to expect regarding infusion schedules and monitoring. Be prepared for regular clinic visits for blood tests, scans to check your tumor response, and to report any side effects. Understand that this is an open-label trial, meaning both you and your doctor will know which treatment you are receiving. The trial is being conducted at 20 sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.

AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.

Study Design

Interventions

Primary Outcomes

Full Eligibility Criteria

Inclusion Criteria:

* Confirmed diagnosis of aggressive NHL of B-cell origin. For enrollment into the DLBCL specific cohort: DLBCL, High-grade B-cell Lymphoma or PMBCL.
* Patient must have progressed or demonstrated intolerance to at least two lines of FDA-approved therapies, one of which must have included anti-CD20 monoclonal antibody therapy. The following are permitted: Prior autologous hematopoietic stem cell transplantation, prior treatment with FDA-approved CAR-T therapy, and/or prior treatment with an investigational agent. Prior treatment(s) with an FDA-approved CAR-T cell therapy or other cell therapies is permitted as long the patients are not considered to be refractory to this previous cell therapy approach (defined as progression within 120 days from the infusion of the cell therapy approach).
* Patient must have disease that allows for response assessment using the Lugano classification criteria.
* Ability to understand and sign the ICF.

Exclusion Criteria:

* Active CNS lymphoma or CNS involvement unless there is a history of at least 3 months of sustained remission of treated disease.
* History of clinically significant structural cardiac disease.
* Cardiac ejection fraction of \< 45% on echocardiogram or MUGA scan at screening assessment.
* Inadequate pulmonary function.
* History of a solid organ allograft, or an inflammatory or autoimmune disease likely to be exacerbated by IL-2.
* Ongoing uncontrolled systemic infections.
* Positive HIV PCR test
* Positive for Hepatitis B or Hepatitis C
* Prior allogeneic stem cell transplant.
* Females of childbearing potential must be willing and able to use appropriate contraception for duration of trial and for 6 months following final AB-101 dose. Males must be sterile or commit to using appropriate contraception until 90 days following the final dose of AB-101.
* Individuals who are pregnant or lactating are ineligible.
* Patients who received a previous genetically modified cell therapy product (e.g., CD19 CAR-T), and progressed within 120 days from the time of the cell therapy infusion

Trial Locations

Frequently Asked Questions

What is clinical trial NCT04673617?

NCT04673617 is a Phase 2 INTERVENTIONAL study titled "AB-101 as Monotherapy and With Immunotherapy in Patients With Relapsed/Refractory B-Cell Non-Hodgkin Lymphoma." It is currently completed and is sponsored by Artiva Biotherapeutics, Inc.. The trial targets enrollment of 45 participants.

What conditions does NCT04673617 study?

This trial investigates treatments for Non Hodgkin Lymphoma. The primary condition under study is Non Hodgkin Lymphoma.

What treatments are being tested in NCT04673617?

The interventions being studied include: AB-101 (DRUG), Rituximab (DRUG), Interleukin-2 (DRUG), Cyclophosphamide (DRUG), Fludarabine (DRUG). NK cell therapy

What does Phase 2 mean for NCT04673617?

Phase 2 trials test whether the treatment works for the intended condition. They involve 100-300 patients and continue to evaluate safety while measuring effectiveness.

What is the current status of NCT04673617?

This trial is currently "Completed." It started on 2021-03-29. The estimated completion date is 2025-10-06.

Who is sponsoring NCT04673617?

NCT04673617 is sponsored by Artiva Biotherapeutics, Inc.. The sponsor is responsible for funding, designing, and overseeing the clinical trial.

How many people can participate in NCT04673617?

The trial aims to enroll 45 participants. The trial status is completed.

How is NCT04673617 designed?

This is a interventional study, uses non_randomized allocation, follows a sequential design, employs none masking.

What are the primary outcomes being measured in NCT04673617?

The primary outcome measures are: Phase 1: Safety and tolerability of AB-101 as monotherapy, and in combination with rituximab (including the DLBCL specific cohort) and in combination with bendamustine and rituximab. (From the ICF signature through 13 weeks after last study drug dose.); Phase 1, combination therapy: AB-101 clinical activity, determined by ORR (From baseline disease assessment through end of study participation.); Phase 1, combination therapy: Identify the recommended Phase 2 dose (R2PD) for AB-101. (From ICF signature through 13 weeks after last study drug dose.); Phase 2: Determine the efficacy profile of AB-101 in combination with rituximab or in combination with bendamustine and rituximab when administered to patients with R/R NHL of B-cell origin. (From baseline disease assessment through end of study participation.). These are the main endpoints researchers use to determine whether the treatment is effective.

Where is NCT04673617 being conducted?

This trial is being conducted at 20 sites, including Birmingham, Alabama; Tucson, Arizona; Orange, California; San Diego, California and 16 more sites (United States).

Where can I find official information about NCT04673617?

The official record for NCT04673617 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT04673617. This government database provides the most up-to-date and detailed information about the trial.

What is NCT04673617 testing in simple terms?

This trial tests a new treatment called AB-101, which uses natural killer (NK) cells, a type of immune cell that fights cancer. It is for adults with B-cell non-Hodgkin lymphoma that has returned or did not respond to previous treatments.

Why is this trial significant?

This trial explores a novel cell therapy approach using NK cells, aiming to provide a new treatment option for patients with difficult-to-treat B-cell lymphomas who have exhausted standard therapies.

What are the potential risks of participating in NCT04673617?

Common side effects may include fever, fatigue, and low blood cell counts, as the treatment stimulates your immune system. There is a risk of infusion-related reactions, which can include flu-like symptoms, and potential for cytokine release syndrome, a more serious immune reaction. As with any cancer treatment, there is a risk that the therapy may not be effective or could cause unexpected side effects. As with any clinical trial, participants are closely monitored and can withdraw at any time.

Should I consider participating in NCT04673617?

Ask your doctor about the specific treatment combinations being tested and what to expect regarding infusion schedules and monitoring. Be prepared for regular clinic visits for blood tests, scans to check your tumor response, and to report any side effects. Understand that this is an open-label trial, meaning both you and your doctor will know which treatment you are receiving. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.

What does NCT04673617 signal from an investment perspective?

This trial targets a significant unmet need in relapsed/refractory lymphoma, a market with substantial patient populations, and represents an investment in the growing field of cell-based immunotherap This is a Phase 2 trial, which is focused on confirming efficacy before larger pivotal studies.

What happens if the treatment in this trial doesn't work?

Participation involves receiving AB-101 alone or with other standard therapies, with regular health and tumor assessments. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.

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This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.