Not yet recruitingRare disease

Study of teclistamab plus autologous lymphocyte infusion in patients with relapsed or refractory multiple myeloma

Verified siteRegistered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

The study focuses on patients with Multiple Myeloma that has come back after treatment or does not respond to standard therapies, known as relapsed or refractory disease. The investigational approach combines a medication called teclistamab, given by a subcutaneous injection (an injection under the skin), with an infusion of the patient’s own immune cells, described as autologous lymphocytes infusion, which means immune cells are collected from the patient, processed, and returned to help fight the cancer. The purpose of the study is to determine how well this combination works in keeping the disease under control over time.

Participants will receive the initial dose of teclistamab followed by regular injections and periodic infusions of their own lymphocytes over several months. Throughout the study, doctors will check the response of the disease at scheduled visits, monitor overall health, and watch for any side effects, including signs of cytokine release syndrome (a reaction that can cause flu‑like symptoms) and neurological changes known as ICANS (a type of brain inflammation). The overall period of observation will extend up to two years to assess how long the treatment benefits last and to ensure safety.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initiate low‑dose teclistamab
The patient receives teclistamab at a dose of 0.3 mg/kg by subcutaneous injection, administered according to the study schedule.
This initial dosing period marks the start of the trial treatment.
Step 2
Dose escalation of teclistamab
After the initial period, the dose of teclistamab is increased to 3 mg/kg, still delivered by subcutaneous injection.
The higher dose is continued for the remainder of the study unless adjustments are required.
Step 3
Autologous lymphocyte infusion combined with teclistamab
The patient receives an infusion of their own lymphocytes (autologous lymphocyte infusion) while continuing the scheduled teclistamab injections.
This combination therapy is intended to enhance the anti‑myeloma effect.
Step 4
Response assessments at cycle 5 and subsequent cycles
The patient undergoes evaluation of disease response at the end of cycle 5 and then after every 3 additional treatment cycles.
Responses are measured using standardized criteria to determine effectiveness.
Step 5
Continued treatment and monitoring up to 24 months
The patient continues receiving teclistamab (and the lymphocyte infusion if applicable) for up to 24 months from the start of the low‑dose phase.
Regular monitoring includes safety checks and observation for possible side effects such as cytokine release syndrome and neurotoxicity.
Step 6
Final follow‑up for overall survival
At 24 months after the start of therapy, a final assessment is performed to record overall survival and any long‑term outcomes.
This completes the trial participation for the patient.

Who can join the trial?

14 criteria

Must have a confirmed diagnosis of multiple myeloma according to the WHO 2022 classification.
Laboratory tests must show: total lymphocyte count ≥ 0.3 × 10⁹/L; platelet count > 50 × 10⁹/L (unless low because the disease is in the bone marrow); bilirubin up to twice the normal limit (unless the liver is affected by the disease); alkaline phosphatase and transaminases up to twice the normal limit (unless the liver is affected); and creatinine clearance ≥ 30 mL/min (a measure of kidney function).
If you are a woman who could become pregnant, you must have a negative, highly sensitive pregnancy test taken 2‑7 days before the first day of treatment.
Life expectancy must be at least 2 months.
At least 100 × 10⁶ (100 million) autologous lymphocytes per kilogram of body weight must have been successfully collected before starting the study treatment.
You must understand the study and voluntarily sign an informed consent form.
You must be 18 years of age or older.
Your disease must be either relapsed (it improved with prior therapy but then got worse at least 60 days after stopping that therapy) or refractory (it never responded or got worse within 60 days after stopping prior therapy), as defined by the International Myeloma Working Group (IMWG) criteria.
You may have had only one or two prior lines of treatment (a line includes all therapy given together, such as induction, stem‑cell transplant, consolidation, and maintenance).
You must have had a triple exposure to three drug classes: an IMID (immunomodulatory drug), a PI (proteasome inhibitor), and an anti‑CD38 antibody (such as daratumumab), and you must have had no response or a relapse after that front‑line therapy.
Your disease must be actively symptomatic and getting worse (progressive active disease).
Your disease must be measurable, meaning any one of the following: serum M‑protein level ≥ 0.5 g/dL; urine M‑protein level ≥ 200 mg per 24 hours; or serum free light chain ≥ 10 mg/dL with an abnormal kappa/lambda ratio.
You must have an ECOG performance status of ≤ 2 (you are fully active, capable of light work, or able to care for yourself).
You must be able to follow the study visit schedule and all other protocol procedures.

Who cannot join the trial?

24 criteria

Had more than two different treatment regimens (called lines of therapy) for multiple myeloma before the study.
Has a past cancer other than multiple myeloma that is likely to come back and would need whole‑body (systemic) treatment.
Has an active cancer (getting worse or needing a change in treatment) within the last 24 months, except for a few cancers that are considered cured, such as certain non‑muscle‑invasive bladder cancers, non‑melanoma skin cancers, localized cervical cancer, certain early‑stage breast or prostate cancers, and other cancers judged to have a very low risk of returning.
Has significant liver or kidney problems, or important heart, blood‑vessel, lung, digestive, hormone, nerve, joint, blood, mental‑health, or metabolism disorders that are currently affecting health.
Has any other severe or uncontrolled medical condition, for example uncontrolled diabetes, uncontrolled high blood pressure, active heart disease, chronic lung disease (COPD), ongoing bleeding, serious psychiatric illness, or an infection that the doctor believes makes participation too risky.
Had major surgery or a serious injury within the past two weeks, has not fully recovered from such surgery, or plans to have major surgery while being treated in the study.
Has an acute infection that required antibiotics, antivirals, or antifungal medicines within the past 14 days.
Is known to be HIV positive (infection with the human immunodeficiency virus).
Shows an active hepatitis B infection, identified by a positive hepatitis B surface antigen (HBsAg) test.
Has an active hepatitis C infection, shown by a positive hepatitis C RNA test.
Has involvement of the brain or spinal cord (central nervous system) by multiple myeloma.
Has previously received any therapy that targets the BCMA protein (a type of treatment for myeloma).
Has taken certain anti‑myeloma medicines or experimental treatments too recently, such as:
- Targeted or epigenetic drugs or investigational agents within the last 21 days (or less than five drug half‑lives).
- An investigational vaccine within the last 4 weeks.
- A monoclonal antibody (lab‑made immune protein) within the last 21 days.
- Chemotherapy (cell‑killing drugs) within the last 21 days.
- Proteasome inhibitor therapy within the last 14 days.
- IMiD (immune‑modulating) therapy within the last 14 days.
- Radiation therapy within the last 21 days or focal radiation within the last 7 days.
- Received gene‑modified cell therapies (such as CAR‑T cells or engineered natural killer cells) within the past three months.
- Has had a stem‑cell transplant: either a previous allogeneic (donor) transplant, or an autologous (self‑derived) transplant within the last 12 weeks.
- Has plasma cell leukemia, which means 5 % or more plasma cells are found in a normal blood test.
- Has a life‑threatening allergy, severe hypersensitivity, or intolerance to any of the study drugs or their ingredients.
- Has an ongoing myelodysplastic syndrome (a bone‑marrow disorder) or another B‑cell cancer besides multiple myeloma.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Azienda Ospedaliera Papa Giovanni XXIII
Verified
Bergamo, Italy
Azienda Ospedaliero Universitaria Careggi
Responsive
Florence, Italy
Universita Degli Studi Di Roma La Sapienza
Responsive
Rome, Italy

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Investigated drugs

Teclistamab
is a lab‑made protein that helps the immune system recognize and attack multiple myeloma cells. In this study it is given as a subcutaneous injection, meaning it is injected under the skin. The drug works by linking a part of the immune system to a marker that is found on myeloma cancer cells, encouraging the body’s own defenses to target and destroy those cells.
Autologous lymphocytes infusion
involves collecting immune cells (lymphocytes) from the patient’s own blood, treating or expanding them in the laboratory, and then infusing them back into the patient. These personalized immune cells are intended to boost the body’s natural ability to fight the cancer when used together with Teclistamab.

Teclistamab

What is already known about the treatment

TECLISTAMAB - This medication is given as a subcutaneous injection, meaning it is injected just under the skin. It is currently investigational and is being studied in clinical trials for safety and effectiveness. The drug is intended for patients with relapsed or refractory multiple myeloma, a type of blood cancer that has returned after previous treatment. It works as a bispecific antibody that connects a patient's T‑cells to cancer cells by targeting BCMA on the tumor and CD3 on the T‑cell, helping the immune system attack the cancer; it belongs to the class of immunotherapy bispecific T‑cell engagers.

Investigated diseases

Relapsed and Refractory Multiple Myeloma - Multiple Myeloma is a cancer of plasma cells in the bone marrow that produces abnormal proteins. After initial therapy, the disease can return, which is called relapse, and may no longer respond to standard treatments, termed refractory. The cancer cells continue to grow, causing increasing amounts of abnormal protein and crowding out normal blood cells. As it progresses, patients may experience bone pain, anemia, and reduced immune function. The condition often shows a pattern of repeated worsening despite therapy.