A Study to Investigate the Safety and Preliminary Efficacy of ALLO-329, an Allogeneic CAR T-cell Therapy, in Adults With Autoimmune Disease
A Phase 1 Study Evaluating the Safety and Preliminary Efficacy of ALLO-329, a Dual Anti-CD19/Anti-CD70 Allogeneic CAR T Cell Product in Autoimmune Disease
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years to 74 Years
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests ALLO-329, a treatment made from donor immune cells changed to target other immune cells. It checks safety, side effects, and early signs that the treatment works. It is for adults with active lupus, with or without kidney disease; IIM, which causes muscle swelling; or systemic sclerosis, which causes tissue hardening.
This is a first-in-human, single-arm, open-label study evaluating the safety, tolerability, and preliminary efficacy of ALLO-329 in adults with autoimmune diseases: systemic lupus erythematosus (SLE) with and without renal involvement, idiopathic inflammatory myopathy (IIM), and systemic sclerosis (SSc).The purpose of this trial is to evaluate the safety and tolerability of ALLO-329, an allogeneic anti-CD19, anti-CD70 dual chimeric antigen receptor (CAR) T cell therapy, in adults with autoimmune disorders, provide initial evidence of biological activity and clinical response to the treatment and determine the recommended Phase 2 regimen (RP2R).
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Be age 18 to 74.
- Have healthy enough blood counts, liver, heart, and lungs.
- Have confirmed, active lupus, IIM, or systemic sclerosis.
- Still have active disease despite standard treatment, including at least 3 months of a medicine that lowers immune system activity.
- Have a negative pregnancy test at screening if you can become pregnant.
- If able to have children, agree to use highly effective birth control after the later of preparatory chemotherapy or ALLO-329: at least 12 months for females and 6 months for males.
- Sign and date a form agreeing to join after learning about the study.
- Be willing and able to follow the treatment plan and attend visits, tests, and other study procedures.
Who can't join
- Have a serious infection or an active infection needing whole-body treatment; have an inherited immune system weakness; or cannot benefit from, or refuse, needed blood transfusions.
- Have had active cancer within the past 5 years. Some treated or low-risk cancers may be allowed.
- Have had treatment targeting CD19 or CD70, or treatment with changed immune cells such as CAR T cells. Earlier ALLO-329 treatment in this study is allowed.
- Have a serious, unstable, or poorly controlled illness, or moderate to severe liver scarring.
- Have certain heart or blood vessel problems; airway disease needing treatment; moderate or worse fluid around the lungs; or a lung blood clot needing blood thinners within 6 months before ALLO-329.
- Are unwilling to take part in long-term safety checks.
- For lupus: have drug-caused lupus or brain or spinal cord involvement within 6 months. For lupus kidney disease, exclusions include dialysis within 12 months before consent, expected kidney replacement treatment within 12 months after dosing, or certain levels of kidney scarring.
- For IIM: have an excluded muscle disease, weakness that cannot be assessed or reversed or has another cause, or dermatomyositis with the anti-TIF1 gamma antibody. For systemic sclerosis: have high blood pressure in lung arteries needing treatment, severe or quickly worsening digestive disease, or a past scleroderma kidney crisis.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
Inclusion Criteria: 1. Adults ≥ 18 to \< 75 years of age. 2. Adequate hematological function and liver, cardiac, and pulmonary function. 3. A highly sensitive urine pregnancy test or serum pregnancy test (for females of childbearing potential) negative at screening. All participants of childbearing potential must be willing to use a highly effective method of contraception for at least 12 months for females (6 months for males) after LD chemotherapy or ALLO-329 administration, whichever is later. 4. Signed and dated informed consent form. 5. Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other procedures. 6. Confirmed active disease (SLE, IIM, or SSc) as defined by the appropriate classification criteria for each respective disease, clinical evidence, and/or laboratory testing. 7. Disease activity as above despite prior treatment with standard of care therapy including at least one immunosuppressive agent for at least 3 months. Exclusion Criteria: 1. Participants with active systemic bacterial, fungal, or viral infection requiring systemic treatment or a clinically significant active, opportunistic, chronic or recurrent infection. 2. Any active malignancy within 5 years prior to enrollment, except for adequately treated localized basal cell or squamous cell skin cancer, carcinoma in situ or low risk prostate cancer (Gleason score ≤ 6) under observation. Prior treatment of cancer with curative intent which in the opinion of the treating oncologist has less than a 10% chance of recurrence in the next 10 years can be allowed after discussion with the sponsor. 3. Prior treatment with CD19 or CD70 targeted therapy or any prior engineered cell therapy (e.g., CAR T therapy), except prior treatment with ALLO-329 in this study. 4. Clinically significant or unstable or uncontrolled acute or chronic disease (e.g., hypothyroidism and diabetes). 5. Symptomatic cardiac or vascular disease requiring medical intervention within 6 months prior to screening, hemodynamically symptomatic pericardial effusion, or symptomatic electrocardiogram abnormality requiring medical intervention. 6. Child-Pugh Class B or C cirrhosis. 7. Symptomatic airway disease requiring medical intervention, pleural effusion ≥ Grade 2, or history of pulmonary embolism requiring anticoagulant therapy within 6 months of ALLO-329 dosing. 8. Participants known to be refractory to platelet or red blood cell transfusions or who will refuse indicated transfusion support to manage cell counts following treatment. 9. Any form of primary, inherited immunodeficiency. 10. Unwilling to participate in an extended safety monitoring period. 11. For participants with SLE: History or active disease involving CNS within the last 6 months or SLE that is drug-induced. For those with lupus nephritis, history of dialysis within 12 months prior to signing the informed consent form or expected need for renal replacement therapy within the next 12 months after dosing, or National Institutes of Health (NIH) chronicity score of 3+ in any of the following domains: glomerular sclerosis, glomerular fibrous crescents, tubular atrophy, and/or interstitial fibrosis. 12. Participants with IIM: A myositis other than specified classification per exclusion criteria, non-reversible, unrelated or weakness not amenable to assessment, or dermatomyositis with presence of anti-TIF1 gamma antibody. 13. Participants with SSc: Pulmonary arterial hypertension requiring treatment, rapidly progressive or severe SSc gastrointestinal involvement, or prior scleroderma renal crisis.
Study sites (16)
AZ
- Mayo Clinic · Phoenix, AZ 85054Vivek Nagaraja, MD · Principal investigatorMore trials in Phoenix
CA
- Loma Linda University Medical Center · Loma Linda, CA 92354Hisham Abdel-Azim, MD · Principal investigatorMore trials in Loma Linda
CO
- University of Colorado Denver · Aurora, CO 80045Melissa Griffith, MD · Principal investigatorMore trials in Aurora
FL
- Mayo Clinic · Jacksonville, FL 32224Vikas Majithia, MD · Principal investigatorMore trials in Jacksonville
IA
- University of Iowa · Iowa City, IA 52242Hanna Zembrzuska, MD · Principal investigatorMore trials in Iowa City
IL
- The University of Chicago Medical Center · Chicago, IL 60637Michael Macklin, MD · Principal investigatorMore trials in Chicago
KS
- University of Kansas Medical Center · Kansas City, KS 66160Paul Schmidt, MD · Principal investigatorMore trials in Kansas City
KY
- Norton Cancer Institute, St. Matthews Campus · Louisville, KY 40207Don Stevens, MD · Principal investigatorMore trials in Louisville
MD
- Johns Hopkins Hospital · Baltimore, MD 21224Maximillian Konig, MD · Principal investigatorMore trials in Baltimore
NC
- Atrium Health Rheumatology-Southpark · Charlotte, NC 28211Leslie Ranken, MD · Principal investigatorMore trials in Charlotte
- Duke University Medical Center · Durham, NC 27710Lisa Criscione-Schreiber, MD · Principal investigatorMore trials in Durham
NJ
- Astera Cancer Care · East Brunswick, NJ 08816Birju Bhatt, MD · Principal investigatorMore trials in East Brunswick
NY
- Icahn School of Medicine at Mount Sinai · New York, NY 10029Margrit Wiesendanger, MD · Principal investigatorMore trials in New York
SC
- Medical University of South Carolina · Charleston, SC 29605Melissa Cunningham, MD · Principal investigatorMore trials in Charleston
- Prisma Health · Greenville, SC 29425Cory McGee, MD · Principal investigatorMore trials in Greenville
UT
- LDS Hospital - lntermountain Health · Salt Lake City, UT 84143Pankhuri Gupta, MD · Principal investigatorMore trials in Salt Lake City