Is NCT05020444 recruiting in Boston, MA?

Yes, NCT05020444 is currently recruiting participants at its Boston, MA location. This multiple myeloma clinical trial is actively enrolling qualified participants.

How do I join the multiple myeloma clinical trial in Boston?

To join this clinical trial in Boston, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Boston clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Multiple Myeloma Clinical Trial in Boston, MA

About This Multiple Myeloma Study in Boston

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

Sponsor: Marcela V. Maus, M.D.,Ph.D.

Who Can Participate

Inclusion Criteria

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

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

Exclusion Criteria

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

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)

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Boston?

Yes, this clinical trial (NCT05020444) has an active research site in Boston, MA that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Multiple Myeloma Treatment Options in Boston, MA

If you're searching for multiple myeloma treatment options in Boston, MA, this clinical trial (NCT05020444) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Boston research site is actively enrolling participants for this clinical trial. You'll receive care from experienced multiple myeloma specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all multiple myeloma clinical trials near you to find additional studies recruiting in your area.

Multiple Myeloma Clinical Trial in Boston, MA

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