Teclistamab + Daratumumab for Amyloidosis

Overseen By Central Nurse Navigator, RN

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Suzanne Lentzsch, MD

Must not be taking: Investigational agents

Disqualifiers: Multiple myeloma, Cardiovascular, Malignancy, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Compensation: Varies

Number of Visits: 19

Duration: 6 months

25 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a combination of two drugs, teclistamab and daratumumab, to determine their effectiveness and safety in treating AL amyloidosis. AL amyloidosis is a rare condition where abnormal proteins accumulate in organs, impairing their function. The trial seeks participants diagnosed with AL amyloidosis who have not yet received treatment targeting plasma cells. Those experiencing symptoms such as organ issues due to amyloidosis may find this trial suitable. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, you cannot have received any prior plasma cell clone-directed therapy, and you should not be on any other investigational agents at the same time.

Is there any evidence suggesting that the teclistamab-daratumumab combination is likely to be safe for humans?

Research shows limited information on the safety of combining teclistamab and daratumumab for treating AL amyloidosis. Teclistamab has shown promise in other conditions, but further research is needed to assess its safety. Some studies have found serious heart-related side effects when daratumumab is combined with other drugs.

This study is in its second phase, indicating that early trials have demonstrated some level of safety. However, more data is needed to fully understand potential side effects. Interested individuals should consult a healthcare provider to discuss the benefits and risks. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the combination of teclistamab and daratumumab for treating amyloidosis because it introduces a novel approach to tackling the disease. Most current treatments for amyloidosis focus on targeting the amyloid proteins themselves. However, teclistamab is a bispecific antibody that uniquely directs the immune system to attack specific cells involved in the disease, offering a different mechanism of action. When combined with daratumumab, a well-established antibody that also helps the immune system fight the disease, this duo has the potential to enhance treatment efficacy beyond what's currently available. This innovative pairing could lead to improved outcomes for patients in a shorter timeframe than traditional therapies.

What evidence suggests that the teclistamab-daratumumab combination might be an effective treatment for amyloidosis?

Research has shown that combining teclistamab and daratumumab may effectively treat AL amyloidosis. In one study with eight patients, all experienced at least a very good partial improvement, with their protein levels returning to normal. Impressively, the disease became undetectable in six of these patients. Although data specifically for AL amyloidosis remains limited, these early results encourage this treatment combination. In this trial, all participants will receive both teclistamab and daratumumab to further evaluate their combined effectiveness. ^{1 2 3 6 7}

Who Is on the Research Team?

Suzanne Lentzsch, MD, PhD

Principal Investigator

Columbia University

Are You a Good Fit for This Trial?

This trial is for individuals with AL Amyloidosis, a condition where abnormal proteins build up in organs. Participants should meet specific health criteria set by the study's guidelines but these are not detailed here.

Inclusion Criteria

I am over 18 and can sign the consent form myself or have someone legally authorized to do so.

Ability to comply with the study protocol, in the investigator's judgment

I agree to not have unprotected sex or donate sperm.

Exclusion Criteria

I have serious heart conditions.

I am on dialysis.

I am scheduled for a stem cell transplant within the first 6 treatment cycles.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive teclistamab and daratumumab in cycles, each lasting 28 days, for a total of 6 months

6 months

Throughout Cycle 1 (each cycle is 28 days), Day 0, Day 1, Day 3, Day 8, Day 15, Day 22; Throughout Cycle 2 and Cycle 6 on Day 1 and Day 15

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

Post treatment follow-up (up to 18 months)

What Are the Treatments Tested in This Trial?

Interventions

• Daratumumab
• Teclistamab

Trial Overview The trial is testing the effectiveness and safety of combining two drugs, Teclistamab and Daratumumab with Hyaluronidase-fihj, over a treatment period lasting 6 months with each cycle being 28 days long.

How Is the Trial Designed?

Group I: Teclistamab-Daratumumab Experimental Treatment 2 Interventions

All participants in this study will receive teclistamab and daratumumab.

Who Is Running the Clinical Trial?

Suzanne Lentzsch, MD

Lead Sponsor

Trials

1

Recruited

20+

Janssen Pharmaceuticals

Industry Sponsor

Trials

87

Recruited

208,000+

Joaquin Duato

Janssen Pharmaceuticals

Chief Executive Officer since 2022

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

Dr. Jijo James, MD

Janssen Pharmaceuticals

Chief Medical Officer since 2014

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

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07110844

Teclistamab-Daratumumab in AL Amyloidosis The purpose of this study is to assess the effectiveness and safety of teclistamab-daratumumab combination in newly diagnosed AL amyloidosis. The study aims to ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11798760/

Safety and Efficacy of Teclistamab in Patients With ... 3. Results · 3.2. Efficacy. All eight patients achieved at least VGPR and had normalization of FLC, and six (75%) patients achieved undetectable ...

3. arci.org arci.org/wp-content/uploads/2025/11/AL-Clinical-Trials-Nov-2025.pdf

AL Amyloidosis Booklets Assess the effectiveness and safety of teclistamab-daratumumab combination; evaluate whether this combination is able to effectively ...

4. nature.com nature.com/articles/s41408-023-00950-3

Safety and efficacy of teclistamab in systemic ... There are no prospective or retrospective studies documenting the safety and efficacy of teclistamab in patients with AL amyloidosis.

5. frontiersin.org frontiersin.org/journals/oncology/articles/10.3389/fonc.2025.1664171/full

Safety and efficacy assessment of teclistamab in relapsed/ ... The objective of our study was to report real-world data on the safety and efficacy of teclistamab in patients with relapsed/refractory AL. Introduction.

6. ashpublications.org ashpublications.org/blood/article/142/Supplement%201/2035/499121/Safety-and-Efficacy-of-Teclistamab-in-Patients

Safety and Efficacy of Teclistamab in Patients with Relapsed ... Teclistamab shows promise in treating patients with relapsed AL amyloidosis, but further prospective studies and longer duration of follow-up ...

7. jnj.com jnj.com/media-center/press-releases/janssen-presents-updated-data-at-eha-for-teclistamab-in-patients-with-relapsed-or-refractory-multiple-myeloma

Janssen Presents Updated Data at EHA for Teclistamab in ... Serious or fatal cardiac adverse reactions occurred in patients with AL amyloidosis who received DARZALEX FASPRO® in combination with bortezomib ...