Boston, MANCT04220190Now EnrollingIRB Ready

Amyotrophic Lateral Sclerosis Clinical Trial in Boston, MA

Access cutting-edge amyotrophic lateral sclerosis treatment through this clinical trial at a research site in Boston. Study-provided care at no cost to qualified participants.

Sponsored by Rapa Therapeutics LLC

Quick Self-Assessment

See if you qualify for this Boston location

Preparing your pre-screening questions…

Expert Care in Boston

Access amyotrophic lateral sclerosis specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related amyotrophic lateral sclerosis treatment provided free

Apply for This Boston Location

Check if you qualify for this amyotrophic lateral sclerosis clinical trial in Boston, MA

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Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Local to Boston

    Convenient for MA residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Boston site if eligible
  4. 4Begin participation

About This Amyotrophic Lateral Sclerosis Study in Boston

RAPA-501-ALS is a phase 2/3 expansion cohort study of RAPA-501 autologous hybrid TREG/Th2 cells in patients living with amyotrophic lateral sclerosis (pwALS).

Sponsor: Rapa Therapeutics LLC

Who Can Participate

Inclusion Criteria

Male or female patients ≥ 18 years of age.
Patients with sporadic or familial amyotrophic lateral sclerosis (ALS) diagnosed as laboratory-supported possible, probable, or definite according to World Federation of Neurology El Escorial Criteria.
. Less than or equal to 24 months since ALS symptom onset.
Total ALSFRS-R score between 34 and 45.
Must have a source of autologous T cells potentially sufficient to manufacture RAPA-501 cells, as defined by a peripheral CD3+ T cell count ≥ 500 cells per μl.
Patients may continue riluzole (Rilutek®), and/or edaravone (Radicava®), and/or sodium phenylbutyrate/taurusodial (Relyvrio™) if on a stable dose for at least 30 days prior to the screening visit.
Patients must be ≥ 2 two weeks removed from major surgery or investigational therapy.
Patients must have recovered from clinical toxicities (\[resolution of CTCAE(v5) \[version 5\] toxicity to a value of ≤ 2\].).
Serum creatinine ≤ less than or equal to 2.0 mg/dL.
Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 x upper limit of normal (ULN).
Bilirubin ≤ 1.5 (except if due to Gilbert's disease).
Pulmonary slow vital capacity (SVC) ≥ 70% of predicted normal.
No history of abnormal bleeding tendency.
Voluntary written consent must be given before performance of any study related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the patient participant at any time without prejudice to future medical care.

Exclusion Criteria

Active uncontrolled infection.
Hypertension not adequately controlled by ≤ 3 medications.
History of documented pulmonary embolus within 6 months of enrollment.
Clinically significant cardiac pathology, as defined by: myocardial infarction within 6 months prior to enrollment, Class III or IV heart failure according to NYHA, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities.
Patients with history of coronary artery bypass grafting or angioplasty will receive a cardiology evaluation and be considered on a case-by-case basis.
HIV, hepatitis B, or hepatitis C seropositive.
Pregnancy or breastfeeding patients.
Patients of Subjects of childbearing age, or males who have a partner of childbearing potential, who are unwilling to practice contraception.
Patients Subjects may be excluded at the Principal Investigator discretion of the PI or if it is deemed that allowing participation would represent an unacceptable medical or psychiatric risk.

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 (NCT04220190) 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.

Amyotrophic Lateral Sclerosis Treatment Options in Boston, MA

If you're searching for amyotrophic lateral sclerosis treatment options in Boston, MA, this clinical trial (NCT04220190) 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 amyotrophic lateral sclerosis 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 amyotrophic lateral sclerosis clinical trials near you to find additional studies recruiting in your area.

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