Multiple MyelomaPhase 1NCT05020444
TriPRIL CAR T Cells in Multiple Myeloma
A Phase 1 study testing TriPRIL CAR T Cells, Cyclophosphamide and Fludarabine in people with Multiple Myeloma and Multiple Myeloma in Relapse, run by Marcela V. Maus, M.D.,Ph.D. at 1 site in United States.
Trial summary
This research study involves the study of TriPRIL CAR T Cells for treating people with relapsed or refractory multiple myeloma and to understand the side effects when treated with TriPRIL CAR T Cells. This research study involves the study drugs:. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma, Multiple Myeloma in Relapse, Refractory Multiple Myeloma
- What is being tested?
- TriPRIL CAR T Cells, Cyclophosphamide and Fludarabine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Oct 2021to 24 Feb 2028
- Phase
- Phase 1
- 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
- Ability to understand and the willingness to sign a written informed consent document.
- Age ≥18 years at the time of signing informed consent.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Life expectancy of greater than 12 weeks
- Histologically or cytologically confirmed diagnosis of relapsed/refractory multiple myeloma. Documented measurable disease includes at least one or more of the following criteria:
- Serum M-protein ≥1.0 g/dL
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- Urine M-protein ≥200 mg/24 hours
- Involved serum free light chain ≥100 mg/L with abnormal κ/λ ratio
- Bone marrow plasma cells ≥30%
- Relapsed/refractory multiple myeloma with at least 3 prior regimens of systemic therapy including proteasome inhibitor, IMiDs and anti-CD38 antibody; or has "triple-refractory" disease following treatment with proteasome inhibitor, IMiD and anti-CD38 antibody, as part of the same or different regimens.
- Note: IMWG criteria defines refractory disease as disease progression on or within 60 days of receiving a therapy Note: Induction treatment with or without hematopoietic stem cell transplant and with or without maintenance is considered a single regimen.
- Adequate organ and marrow function as defined below:
- O2 saturation ≥92% on room air while awake
- LVEF ≥40% by ECHO or MUGA scan
- ANC ≥1.0k/μl, PLT ≥50k/μl, (NOTE: Platelet transfusion not allowed within 7 days; growth factor neupogen not allowed within 7 days, neulasta within 14 days)
- Creatinine clearance ≥30 mL/min and not on dialysis
- AST/ALT <3 x ULN
- Direct bilirubin <1.5 x ULN (allow x 3 ULN for Gilbert's syndrome)
- PTT, PT/INR <1.5 x ULN, unless on a stable dose of anti-coagulant for a thromboembolic event (Patients with any history of thromboembolic stroke; or history or Grade 2 or greater hemorrhage within 60 days are excluded)
- Resolution of AEs from any prior therapy to ≤ Grade 1 (≤ G2 alopecia and ≤ G2 sensory neuropathy are allowed, cytopenias allowed per eligibility criteria above)
- Participants with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.
- The effects of TriPRIL CAR T cells on the developing human fetus are unknown. Male and female participants of childbearing potential must agree to use highly effective methods of birth control prior to study entry, for the duration of study participation, and through 6 months after completion of TriPRIL CAR T cells administration. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.
- NOTE: Highly effective contraception methods include:
- Total abstinence
- Female sterilization (tubal ligation, bilateral oophorectomy, and/or hysterectomy)
- Male sterilization, at least 6 months prior to screening
- Intrauterine device
- Oral, injected, or implanted hormonal contraception AND barrier methods of contraception
- Willing to comply with and able to tolerate study procedures, including Long-term Safety Follow-up lasting up to 15 years per FDA guidance
Who cannot join
- Treatment with any of the following therapies as specified below:
- Any prior systemic treatment for multiple myeloma within the 14 days prior to scheduled leukapheresis unless discussed with the medical monitor
- Receiving high-dose (e.g., >10 mg prednisone or equivalent) systemic steroid therapy or any other form of immunosuppressive therapy within 14 days prior to leukapheresis
- Autologous stem cell transplantation within 3 months prior to leukapheresis
- Any prior allogeneic stem cell transplantation
- Other CAR-T cell therapy within 6 months of leukapheresis
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- Plasma cell leukemia or history of plasma cell leukemia
- Patients with extramedullary disease only without meeting criteria for measurable disease as per inclusion criteria above.
- No Bispecific T cell engagers withing 6 months of apheresis
- No bendamustine within 6 months of apheresis
- Patients with solitary plasmacytomas without evidence of other measurable disease
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to CAR- T cells
- Contraindication to the protocol-specified doses of fludarabine or cyclophosphamide
- Participants who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities > Grade 1) with the exception of ≤ G2 alopecia and grade ≤2 sensory neuropathy.
- Active bacterial, viral, or fungal infection requiring systemic treatment (isolated fever may not constitute active infection in and of itself, e.g., related to disease)
- Symptomatic congestive heart failure
- Unstable angina, arrhythmia, or myocardial infarction (MI) within 6 months prior to screening
- Significant pulmonary dysfunction
- Auto-immune disease requiring immunosuppressive therapy
- Pulmonary embolism or DVT within three months of enrollment or uncontrolled thromboembolic events. Therapeutic dosing of anticoagulants (e.g., warfarin, low molecular weight heparin, Factor Xa inhibitors) is allowed for history of DVT or PE if greater than three months from time of enrollment. Prophylactic anticoagulation is allowed.
- Recent severe hemorrhage (within the past 60 days)
- Seropositive for and with evidence of active hepatitis B or C infection at time of screening, or HIV seropositive
- Subjects with a history of hepatitis B but have received antiviral therapy and have non-detectable viral DNA for 6 months are eligible
- Subjects seropositive because of hepatitis B virus vaccine with no signs or active infection are eligible
- Subjects who had hepatitis C but have received antiviral therapy and show no detectable HCV viral RNA for 6 months are eligible
- Active central nervous system (CNS) involvement by malignancy. NOTE: subjects who are asymptomatic, stable, and received prior effective treatment for CNS disease may be eligible after discussion with the medical monitor.
- Any sign of active or prior CNS pathology including history of epilepsy, seizure, paresis, aphasia, stroke, subarachnoid hemorrhage or CNS bleed, severe brain injury, dementia, cerebellar disease, Parkinson's disease, organic brain syndrome or psychosis.
- Active malignancy not related to myeloma that has required therapy in the last 3 years or is not in complete remission. Exceptions to this criterion include successfully treated non-metastatic basal cell or squamous cell skin carcinoma, or prostate cancer that does not require therapy. Other similar malignant conditions may be discussed with and permitted by the medical monitor.
- Females who are pregnant or breastfeeding or females of childbearing potential not using an effective method of birth control
- Subjects with any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in study (or full access to medical records) as written including follow up, the interpretation of data or place the subject at unacceptable risk
- Participants taking any other medicine concurrently that may interfere with the study (need to consult with the principle investigator)
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, 02114
About this study
Official title: A Phase I Clinical Trial With TriPRIL CAR T Cells for the Treatment of Patients With Relapsed or Refractory Multiple Myeloma
This research study involves the study of TriPRIL CAR T Cells for treating people with relapsed or refractory multiple myeloma and to understand the side effects when treated with TriPRIL CAR T Cells.
This research study involves the study drugs:.
- TriPRIL CAR T Cells
- Fludarabine and Cyclophosphamide: Standardly used chemotherapy drugs as part of lymphodepleting process
Read the detailed description
This is a two-part, non-randomized, open label, single-site Phase 1 study of TriPRIL CAR T Cells as a treatment for relapsed or refractory multiple myeloma.
This study consists of 2 parts:
- Part A (Dose Escalation) : The investigators are looking to find the highest dose of the study intervention that can be administered safely without severe or unmanageable side effects, not everyone who participates in this research study will receive the same dose of the study intervention. The dose given will depend on the number of participants who have been enrolled prior and how well the dose was tolerated Once determined, this highest dose will then be used in the dose expansion part of the study.
- Part B (Expansion Cohort):Participants will be treated at the respective dose as determined during Part A (Dose Escalation).
TriPRIL CAR T Cells is an investigational treatment that uses a person's own immune cells, called T cells, to try to kill their cancerous cells. T cells fight infections and can also kill cancer cells in some cases. The U.S. Food and Drug Administration (FDA) has not approved TriPRIL CAR T Cells as a treatment for any disease.This is the first time that TriPRIL CAR T Cells will be given to humans.
The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits.
Participants will receive one infusion of the study treatment and will be followed for up to 2 years.
It is expected that about 18 people will take part in this research study.
- Being tested
- TriPRIL CAR T Cells, Cyclophosphamide, Fludarabine
- Keywords
- Multiple Myeloma, Multiple Myeloma in Relapse, Refractory 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.
TriPRIL CAR T CellsDrug
Intravenous infusion
CyclophosphamideDrug
Also called Cytoxan, Neosar
Intravenous infusion
FludarabineDrug
Also called Fludara
Intravenous infusion
| Study group | Role | What they receive |
|---|---|---|
| TriPRIL CAR T Cells-Dose Escalation | Experimental | Prior to receiving TriPRIL CAR T Cells, participants will undergo two preparatory processes:
* Leukapheresis: White blood cells will be collected and manufacture TriPRIL CAR T cells at a GMP manufacturing facility.
* Lymphodepletion: On days, -5, -4. -3 participants will receive 3 days of chemotherapy to decrease the number of lymphocytes
TriPRIL CAR T Cells will be administered intravenously on day 0 using a 3+3 dose escalation design Receives: Drug: TriPRIL CAR T Cells; Drug: Cyclophosphamide; Drug: Fludarabine |
| TriPRIL CAR T Cells-Dose Expansion | Experimental | Prior to receiving TriPRIL CAR T Cells, participants will undergo two preparatory processes:
* Leukapheresis: White blood cells will be collected and manufacture TriPRIL CAR T cells at a GMP manufacturing facility.
* Lymphodepletion: On days, -5, -4. -3 participants will receive 3 days of chemotherapy to decrease the number of lymphocytes
TriPRIL CAR T Cells will be administered intravenously on day 0 using the respective dose (at or below the Maximum Tolerated Dose-MTD), as determined during the dose escalation part. Receives: Drug: TriPRIL CAR T Cells; Drug: Cyclophosphamide; Drug: Fludarabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events (AEs)
Study-related adverse events (AEs) will be listed and tabulated by type and study cohort. The rate of AEs in all infused patients, both within study cohorts and overall, will be calculated and reported with exact 95% confidence intervals. A separate safety analysis will report similar information within patients infused at the target dose of 1x108 or 3x108 TriPRIL CAR T cells.
Measured: Week 24 post dosing, and every three months until two years.
Incidence of Dose Limiting Toxicity (DLT)
Dose-limiting toxicities will be listed and tabulated by type and study cohort.
Measured: Week 24 post dosing, and every three months until two years.
Secondary outcomes (3)
Overall Response Rate (ORR)
Data will be listed, tabulated, and presented descriptively using Kaplan Meier plots.
Measured: 1 month, 6 months, 12 months, and 24 after CAR T cell treatment.
Overall Survival (OS)
Data will be listed, tabulated, and presented descriptively using Kaplan Meier plots.
Measured: 1 month, 6 months, 12 months and 24 months after CAR T cell treatment.
Progression Free Survival (PFS)
Data will be listed, tabulated, and presented descriptively using Kaplan Meier plots.
Measured: 1 month, 6 months, 12 months and 24 months after CAR T cell treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2021
- Study start5 Oct 2021
- Primary completion24 Feb 2028 (estimated)
- Study completion24 Feb 2028 (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.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marcela V. Maus, M.D.,Ph.D.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Marcela V. Maus, M.D.,Ph.D., Massachusetts General Hospital
- Investigators
- Matthew J Frigault, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05020444
- Sponsor's protocol ID
- 20-518
- Status last verified
- May 2026
- First submitted
- 18 Aug 2021
- Last updated
- 7 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: \[contact information for Sponsor Investigator or designee\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Clinical Trial With TriPRIL CAR T Cells for the Treatment of Patients With Relapsed or Refractory Multiple Myeloma
- ClinicalTrials.gov ID
- NCT05020444
- Acronym / sponsor ID
- 20-518
- Keywords
- Multiple Myeloma, Multiple Myeloma in Relapse, Refractory Multiple Myeloma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Marcela V. Maus, M.D.,Ph.D.University, hospital or other
- Study start
- 5 Oct 2021 (actual)
- Primary completion
- 24 Feb 2028 (estimated)
- Study completion
- 24 Feb 2028 (estimated)
- First posted
- 25 Aug 2021 (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 research study involves the study of TriPRIL CAR T Cells for treating people with relapsed or refractory multiple myeloma and to understand the side effects when treated with TriPRIL CAR T Cells.
This research study involves the study drugs:.
- TriPRIL CAR T Cells
- Fludarabine and Cyclophosphamide: Standardly used chemotherapy drugs as part of lymphodepleting process
Detailed description
This is a two-part, non-randomized, open label, single-site Phase 1 study of TriPRIL CAR T Cells as a treatment for relapsed or refractory multiple myeloma.
This study consists of 2 parts:
- Part A (Dose Escalation) : The investigators are looking to find the highest dose of the study intervention that can be administered safely without severe or unmanageable side effects, not everyone who participates in this research study will receive the same dose of the study intervention. The dose given will depend on the number of participants who have been enrolled prior and how well the dose was tolerated Once determined, this highest dose will then be used in the dose expansion part of the study.
- Part B (Expansion Cohort):Participants will be treated at the respective dose as determined during Part A (Dose Escalation).
TriPRIL CAR T Cells is an investigational treatment that uses a person's own immune cells, called T cells, to try to kill their cancerous cells. T cells fight infections and can also kill cancer cells in some cases. The U.S. Food and Drug Administration (FDA) has not approved TriPRIL CAR T Cells as a treatment for any disease.This is the first time that TriPRIL CAR T Cells will be given to humans.
The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits.
Participants will receive one infusion of the study treatment and will be followed for up to 2 years.
It is expected that about 18 people will take part in this research study.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TriPRIL CAR T Cells-Dose Escalation | Experimental | Drug: TriPRIL CAR T Cells, Drug: Cyclophosphamide, Drug: FludarabinePrior to receiving TriPRIL CAR T Cells, participants will undergo two preparatory processes: * Leukapheresis: White blood cells will be collected and manufacture TriPRIL CAR T cells at a GMP manufacturing facility. * Lymphodepletion: On days, -5, -4. -3 participants will receive 3 days of chemotherapy to decrease the number of lymphocytes TriPRIL CAR T Cells will be administered intravenously on day 0 using a 3+3 dose escalation design |
| TriPRIL CAR T Cells-Dose Expansion | Experimental | Drug: TriPRIL CAR T Cells, Drug: Cyclophosphamide, Drug: FludarabinePrior to receiving TriPRIL CAR T Cells, participants will undergo two preparatory processes: * Leukapheresis: White blood cells will be collected and manufacture TriPRIL CAR T cells at a GMP manufacturing facility. * Lymphodepletion: On days, -5, -4. -3 participants will receive 3 days of chemotherapy to decrease the number of lymphocytes TriPRIL CAR T Cells will be administered intravenously on day 0 using the respective dose (at or below the Maximum Tolerated Dose-MTD), as determined during the dose escalation part. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (29 listed)
- Ability to understand and the willingness to sign a written informed consent document.
- Age ≥18 years at the time of signing informed consent.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Life expectancy of greater than 12 weeks
- Histologically or cytologically confirmed diagnosis of relapsed/refractory multiple myeloma. Documented measurable disease includes at least one or more of the following criteria:
Key exclusion criteria (31 listed)
- Treatment with any of the following therapies as specified below:
- Plasma cell leukemia or history of plasma cell leukemia
- Patients with extramedullary disease only without meeting criteria for measurable disease as per inclusion criteria above.
- No Bispecific T cell engagers withing 6 months of apheresis
- No bendamustine within 6 months of apheresis
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 |
|---|---|---|
| TriPRIL CAR T CellsIntravenous infusion | Drug | TriPRIL CAR T Cells-Dose Escalation, TriPRIL CAR T Cells-Dose Expansion |
| CyclophosphamideAlso: Cytoxan, NeosarIntravenous infusion | Drug | TriPRIL CAR T Cells-Dose Escalation, TriPRIL CAR T Cells-Dose Expansion |
| FludarabineAlso: FludaraIntravenous infusion | Drug | TriPRIL CAR T Cells-Dose Escalation, TriPRIL CAR T Cells-Dose Expansion |
Primary outcome
Incidence of adverse events (AEs)
Time frame: Week 24 post dosing, and every three months until two years.
Study-related adverse events (AEs) will be listed and tabulated by type and study cohort. The rate of AEs in all infused patients, both within study cohorts and overall, will be calculated and reported with exact 95% confidence intervals. A separate safety analysis will report similar information within patients infused at the target dose of 1x108 or 3x108 TriPRIL CAR T cells.
Incidence of Dose Limiting Toxicity (DLT)
Time frame: Week 24 post dosing, and every three months until two years.
Dose-limiting toxicities will be listed and tabulated by type and study cohort.
3 secondary outcomes
Overall Response Rate (ORR)
Time frame: 1 month, 6 months, 12 months, and 24 after CAR T cell treatment.
Overall Survival (OS)
Time frame: 1 month, 6 months, 12 months and 24 months after CAR T cell treatment.
Progression Free Survival (PFS)
Time frame: 1 month, 6 months, 12 months and 24 months after CAR T cell treatment.
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 7 Aug 2026.
- Individual participant dataSharing planned: Yes. The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
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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. This study is not recruiting at the moment.
Matthew J Frigault, MD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TriPRIL CAR T Cells, Cyclophosphamide and Fludarabine in people with Multiple Myeloma and Multiple Myeloma in Relapse, run by Marcela V. Maus, M.D.,Ph.D. 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 29 inclusion and 31 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: under way, not looking for participants, as of the sponsor's last update on 7 Aug 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of adverse events (AEs) (time frame: Week 24 post dosing, and every three months until two years.). The study lists 2 primary outcomes in all. 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 7 Aug 2026.