Multiple MyelomaPhase 2RECLAIMNCT07009899
BCMA Bispecific Antibody Therapy for Post-BCMA CAR T-Cell Therapy Relapse (RECLAIM)
A Phase 2 study testing Linvoseltamab in people with Multiple Myeloma, run by Medical College of Wisconsin at 1 site in United States.
Trial summary
This is a single-center, single-arm, phase 2 study designed to evaluate the efficacy and safety of linvoseltamab in multiple myeloma (MM) patients who relapsed following BCMA CAR T-cell therapy, whether standard of care or investigational. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- Linvoseltamab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Aug 2026to 1 Feb 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years.
- Eastern Cooperative Oncology Group (ECOG) Performance Status criteria of 0-3.
- Received any standard of care or investigational BCMA CAR T-cell therapy as their last line of therapy ≥ 6 months prior to enrollment.
- Note: Up to 15% of patients who are < 6 months out from their standard of care of investigational BCMA CAR T-cell therapy will be included in the study as long as i) their bone marrow biopsy sample tests positive for BCMA expression by immunohistochemistry and ii) they have stem cells available for a stem cell boost therapy prior to linvoseltamab administration.
- Must have measurable disease for response assessment as per the IMWG response assessment criteria.
- Note: if a patient does not have measurable serum M or free light chain, evidence of measurable disease by imaging is acceptable (e.g., extramedullary disease, new lesions).
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- Adequate hepatic function as defined below:
- Total bilirubin ≤ 1.5 x the upper limit of the normal range (ULN).
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 x ULN.
- Ability to understand a written informed consent document, and the willingness to sign it.
Who cannot join
- Previously on a BCMA-directed therapy other than BCMA CAR T-cell therapy (e.g., BCMA bispecific antibody, BCMA antibody drug conjugate) or T cell engaging therapy (e.g., GPRC5D bispecific antibody, GPRC5D CAR T-cell therapy).
- History of neurodegenerative condition, Central Nervous System (CNS) movement disorder, or patients with a history of seizure within 12 months prior to study enrollment.
- Any serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment according to this protocol.
- Prior organ transplant requiring immunosuppressive therapy.
- Known to be human immunodeficiency virus (HIV) positive.
- Known to have hepatitis A, B, or C active infection.
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- Known allergy to any of the study medications, their analogues, or excipients in the various formulations of any agent.
- Concurrent hematologic or non-hematologic malignancy requiring treatment (other than multiple myeloma and secondary amyloidosis).
- Cardiac syncope, uncompensated New York Heart Association (NYHA) Class 3 or 4 congestive heart failure, myocardial infarction within the previous six months, unstable angina pectoris, clinically significant repetitive ventricular arrhythmias despite antiarrhythmic treatment, cardiac ejection fraction < 40% by echocardiogram or multi-gated acquisition (MUGA) scan, severe orthostatic hypotension, or clinically important autonomic disease.
- Major surgery within 14 days prior to start of study treatment (Note: vertebroplasty and kyphoplasty are not considered major surgery).
- Infection requiring systemic antibiotic therapy or other serious infection within 14 days prior to start of study treatment.
- Active treatment in other clinical trials, including those where a subject received an investigational drug within 30 days or five half-lives of the investigational drug prior to start of study treatment, whichever is longer.
- Any clinically significant, uncontrolled medical conditions that, in the investigator's opinion, would expose the subject to excessive risk or may interfere with compliance or interpretation of the study results.
- Pregnant or breastfeeding women.
- Women of childbearing potential (WOCBP) or sexually active men who are unwilling to practice highly effective contraception prior to the start of study therapy, during the study, and for at least 6 months after the last dose of the study drug.
- WOCBP are defined as women who are fertile following menarche until becoming postmenopausal (defined as no menses for 12 months without an alternative medical cause), unless permanently sterile. Permanent sterilization methods include hysterectomy, bilateral salpingectomy, and bilateral oophorectomy.
- Male study participants with WOCBP partners are required to use condoms unless they are vasectomized or practice sexual abstinence. Male study participants should not donate sperm during the study, and for at least 6 months after the last dose
- Highly effective contraceptive measures include stable use of combined (estrogen and progestogen-containing) hormonal contraception (oral, intravaginal, transdermal) or progestogen-only hormonal contraception (oral, injectable, implantable) associated with inhibition of ovulation initiated two or more menstrual cycles prior to screening; intrauterine device; intrauterine hormone-releasing system; bilateral tubal ligation; vasectomized partner (provided that the vasectomized partner is the sole sexual partner of the WOCBP study participant); and or sexual abstinence.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Medical College of Wisconsin Cancer Center Clinical Trials Office contact
United States1 site, 1 recruiting
- Recruiting
Froedtert & the Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Binod Dhakal, MD, 414-805-4600, bdhakal@mcw.edu
Binod Dhakal, MD
About this study
This is a single-center, single-arm, phase 2 study designed to evaluate the efficacy and safety of linvoseltamab in multiple myeloma (MM) patients who relapsed following BCMA CAR T-cell therapy, whether standard of care or investigational.
Read the detailed description
This is a single-center, single-arm, phase 2 study designed to evaluate the efficacy and safety of linvoseltamab in multiple myeloma (MM) patients who relapsed following BCMA CAR T-cell therapy, whether standard of care or investigational. The primary objective is to assess overall response rate (ORR) in patients treated with linvoseltamab.
- Conditions
- Multiple Myeloma
- Being tested
- Linvoseltamab
- Keywords
- Bispecific Antibody, BCMA, BCMA CAR T-Cell Therapy, linvoseltamab, Multiple Myeloma
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LinvoseltamabDrug
Linvoseltamab is a human IgG4-based bsAb that binds to CD3, a T-cell antigen associated with the TCR complex, and BCMA, which is expressed on the surface of malignant MM B-lineage cells, as well as late-stage B cells and plasma cells.
| Study group | Role | What they receive |
|---|---|---|
| Linvoseltamab Administration | Experimental | Linvoseltamab intravenous (IV) will be initially administered to all patients as a step-up dosing regimen during the first two weeks of Cycle 1 (Weeks 1 and 2; 5 mg on Cycle 1 Day 1 and 25 mg on Cycle 1 Day 8) in an inpatient setting. Starting with Cycle 1 Day 15 (Week 3), linvoseltamab 200 mg will be administered once a week until the end of Cycle 3 (Week 12) followed by once every two weeks (Days 1 and 15) during Cycles 4 through 6 (Weeks 13 through 24). From Cycle 7 Day 1 (Week 25) until disease progression, linvoseltamab 200 mg will be administered once every four weeks. Receives: Drug: Linvoseltamab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Response Rate
This is the number of subjects who have a partial response (PR) or better according to the International Myeloma Working Group (IMWG) criteria.
Measured: Up to 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2025
- Study start31 Aug 2026
- Primary completion1 Feb 2028 (estimated)
- Study completion1 Feb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by Medical College of WisconsinThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical College of Wisconsin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Binod Dhakal, Medical College of Wisconsin
- Investigators
- Meera Mohan, MD, Principal investigator, Medical College of Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07009899
- Sponsor's protocol ID
- PRO00056695
- Acronym
- RECLAIM
- Status last verified
- Nov 2026
- First submitted
- 30 May 2025
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BCMA Bispecific Antibody Therapy for Post-BCMA CAR T-Cell Therapy Relapse (RECLAIM)
- ClinicalTrials.gov ID
- NCT07009899
- Acronym / sponsor ID
- RECLAIM / PRO00056695
- Conditions
- Multiple Myeloma
- Keywords
- Bispecific Antibody, BCMA, BCMA CAR T-Cell Therapy, linvoseltamab, Multiple Myeloma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Medical College of WisconsinUniversity, hospital or other
- Study start
- 31 Aug 2026 (actual)
- Primary completion
- 1 Feb 2028 (estimated)
- Study completion
- 1 Feb 2029 (estimated)
- First posted
- 8 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a single-center, single-arm, phase 2 study designed to evaluate the efficacy and safety of linvoseltamab in multiple myeloma (MM) patients who relapsed following BCMA CAR T-cell therapy, whether standard of care or investigational.
Detailed description
This is a single-center, single-arm, phase 2 study designed to evaluate the efficacy and safety of linvoseltamab in multiple myeloma (MM) patients who relapsed following BCMA CAR T-cell therapy, whether standard of care or investigational. The primary objective is to assess overall response rate (ORR) in patients treated with linvoseltamab.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Linvoseltamab Administration | Experimental | Drug: LinvoseltamabLinvoseltamab intravenous (IV) will be initially administered to all patients as a step-up dosing regimen during the first two weeks of Cycle 1 (Weeks 1 and 2; 5 mg on Cycle 1 Day 1 and 25 mg on Cycle 1 Day 8) in an inpatient setting. Starting with Cycle 1 Day 15 (Week 3), linvoseltamab 200 mg will be administered once a week until the end of Cycle 3 (Week 12) followed by once every two weeks (Days 1 and 15) during Cycles 4 through 6 (Weeks 13 through 24). From Cycle 7 Day 1 (Week 25) until disease progression, linvoseltamab 200 mg will be administered once every four weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age ≥18 years.
- Eastern Cooperative Oncology Group (ECOG) Performance Status criteria of 0-3.
- Received any standard of care or investigational BCMA CAR T-cell therapy as their last line of therapy ≥ 6 months prior to enrollment.
- Must have measurable disease for response assessment as per the IMWG response assessment criteria.
- Adequate hepatic function as defined below:
Key exclusion criteria (18 listed)
- Previously on a BCMA-directed therapy other than BCMA CAR T-cell therapy (e.g., BCMA bispecific antibody, BCMA antibody drug conjugate) or T cell engaging therapy (e.g., GPRC5D bispecific antibody, GPRC5D CAR T-cell therapy).
- History of neurodegenerative condition, Central Nervous System (CNS) movement disorder, or patients with a history of seizure within 12 months prior to study enrollment.
- Any serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment according to this protocol.
- Prior organ transplant requiring immunosuppressive therapy.
- Known to be human immunodeficiency virus (HIV) positive.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LinvoseltamabLinvoseltamab is a human IgG4-based bsAb that binds to CD3, a T-cell antigen associated with the TCR complex, and BCMA, which is expressed on the surface of malignant MM B-lineage cells, as well as late-stage B cells and plasma cells. | Drug | Linvoseltamab Administration |
Primary outcome
Overall Response Rate
Time frame: Up to 15 months
This is the number of subjects who have a partial response (PR) or better according to the International Myeloma Working Group (IMWG) criteria.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Medical College of Wisconsin Cancer Center Clinical Trials Office contact
Meera Mohan, MD principal investigator
Medical College of Wisconsin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Linvoseltamab in people with Multiple Myeloma, run by Medical College of Wisconsin at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Medical College of Wisconsin Cancer Center Clinical Trials Office (866-680-0505 ext. 8900, cccto@mcw.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Response Rate (time frame: Up to 15 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.