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Relapsed or Refractory Large B Cell Lymphoma, Relapsed or Refractory Chronic Lymphocytic Leukemia, Relapsed or Refractory Small Lymphocytic LymphomaPhase 1/2ALPHA2NCT04416984

Safety and Efficacy of ALLO-501A Anti-CD19 Allogeneic CAR T Cells in Adults With Relapsed/Refractory Large B Cell Lymphoma, Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma (ALPHA2)

A Phase 1/2 study testing ALLO-501A, ALLO-647 and Fludarabine in people with Relapsed or Refractory Large B Cell Lymphoma, Relapsed or Refractory Chronic Lymphocytic Leukemia, Relapsed or Refractory Small Lymphocytic Lymphoma, run by Allogene Therapeutics at 29 sites in 3 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This is a single-arm, open label, multicenter Phase 1/2 study evaluating ALLO-501A in adult subjects with R/R LBCL and CLL/SLL. The purpose of the ALPHA2 study is to assess the safety, efficacy, and cell kinetics of ALLO-501A in adults with relapsed or refractory large B-cell lymphoma and assess the safety of… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
ALLO-501A, ALLO-647 and Fludarabine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
160 participants
Where
29 sitesin 3 countries
Study dates
21 May 2020to May 2029
Phase
Phase 1/2
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

  • For subjects with LBCL:
  • Histologically confirmed diagnosis of relapsed/refractory large B-cell lymphoma at last relapse per WHO 2017
  • At least 1 measurable lesion at time of enrollment
  • Relapsed or refractory disease after at least 2 lines of chemotherapy
  • Absence of significant donor (product)-specific anti-HLA antibodies (DSA) at screening (Note: Only applicable for Phase 2)
  • For subjects with CLL/SLL:
Show all 15Show fewer
  • Diagnosis of CLL/SLL
  • Relapsed/refractory disease
  • Subjects relapsed/refractory to BTKi therapy and high-risk disease
  • Subjects relapsed/refractory with 2 or more lines of therapy including BTKi and BCL-2 inhibitor (venetoclax)
  • At least 1 measurable lesion at time of enrollment
  • For all subjects:
  • Male or female subjects ≥18 years of age
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1
  • Adequate hematological, renal, and liver function

Who cannot join

  • Active central nervous system (CNS) involvement by malignancy
  • Current thyroid disorder (including hyperthyroidism), except for subjects with hypothyroidism controlled on a stable dose of hormone replacement therapy
  • Any other active malignancies that required systemic treatment within 3 years prior to enrollment
  • Radiation therapy within 2 weeks prior to ALLO-647
  • Prior irradiation to >25% of the bone marrow
  • Hypocellular bone marrow for age by institutional standard as determined from a bone marrow biopsy performed at time of screening (Note: Only applicable for Phase 2).
  • Autologous hematopoietic stem cell transplant (HSCT) within last 6 months (24 weeks)
  • Systemic anti-cancer therapy within 2 weeks prior to receiving ALLO-647

Trial locations and contacts

29 sites in 3 countries.

29 sites in 3 countries

United States24 sites

  • Northside Hospital - Atlanta

    Atlanta, Georgia, 30342

  • Augusta University

    Augusta, Georgia, 30912

  • St. David's South Austin Medical Center

    Austin, Texas, 78704

  • Texas Oncology

    Dallas, Texas, 75251

  • Colorado Blood Cancer Institute

    Denver, Colorado, 80218-1234

  • Karmanos Cancer Institute

    Detroit, Michigan, 48201

  • City of Hope

    Duarte, California, 91010

  • Banner MD Anderson Cancer Center

    Gilbert, Arizona, 85234

  • MD Anderson Cancer Center - University of Texas

    Houston, Texas, 77030

  • UCLA Medical Center

    Los Angeles, California, 90095

  • Norton Cancer Institute

    Louisville, Kentucky, 40207

  • Loyola University Medical Center

    Maywood, Illinois, 60153

  • University of Miami

    Miami, Florida, 33136

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • Vanderbilt Ingram Cancer Center

    Nashville, Tennessee, 37232

  • Yale School of Medicine

    New Haven, Connecticut, 06510

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

  • Advent Health

    Orlando, Florida, 06510

  • Stanford Cancer Institute

    Palo Alto, California, 94035

  • Mayo Clinic Hospital

    Phoenix, Arizona, 85054

  • Allegheny General Hospital

    Pittsburgh, Pennsylvania, 15212

  • Providence Portland Medical Center

    Portland, Oregon, 97213

  • Avera Medical

    Sioux Falls, South Dakota, 57117

  • Moffitt Cancer Center

    Tampa, Florida, 33612-9416

Other trials in United States

Australia3 sites

  • Monash Medical Centre

    Clayton, Victoria, 3168

  • St. Vincent's Hospital Melbourne

    Fitzroy, Victoria, 3065

  • Princess Alexandra Hospital

    Woolloongabba, Queensland, 4102

Other trials in Australia

Canada2 sites

  • QEII Health Sciences Centre-VG Site

    Halifax, Nova Scotia, B3H 2Y9

  • CHU de Québec -Université Laval; Hôpital de l'Enfant-Jésus

    Québec, Quebec, G1J 1Z4

Other trials in Canada

About this study

Official title: A Single-Arm, Open-Label, Phase 1/2 Study Evaluating the Safety, Efficacy, and Cellular Kinetics/Pharmacodynamics of ALLO-501A, an Anti-CD19 Allogeneic CAR T Cell Therapy, and ALLO-647, an Anti-CD52 Monoclonal Antibody, in Subjects With Relapsed/Refractory Large B-Cell Lymphoma (LBCL)

This is a single-arm, open label, multicenter Phase 1/2 study evaluating ALLO-501A in adult subjects with R/R LBCL and CLL/SLL. The purpose of the ALPHA2 study is to assess the safety, efficacy, and cell kinetics of ALLO-501A in adults with relapsed or refractory large B-cell lymphoma and assess the safety of ALLO-501A in adults with relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) after a lymphodepletion regimen comprising fludarabine, cyclophosphamide, and ALLO-647.

Being tested
ALLO-501A, ALLO-647, Fludarabine, Cyclophosphamide
Keywords
CAR T, Cell Therapy, Allogeneic Cell Therapy, Cellular Immuno-therapy, AlloCAR T, ALLO-501A, ALLO-647, LBCL, Lymphoma, Large B-Cell Lymphoma, Cema-cel, Cemacabtagene ansegedleucel, Leukemia, Chronic Lymphocytic Leukemia, CLL, Small Lymphocytic Lymphoma, SLL
Medical subject headings
Recurrence, Leukemia, Lymphocytic, Chronic, B-Cell, Lymphoma, Leukemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ALLO-501AGenetic

    ALLO-501A is an allogeneic CAR T cell therapy targeting CD19

  • ALLO-647Biological

    ALLO-647 is a monoclonal antibody that recognizes a CD52 antigen

  • FludarabineDrug

    Chemotherapy for lymphodepletion

  • CyclophosphamideDrug

    Chemotherapy for lymphodepletion

Study groups in NCT04416984
Study groupRoleWhat they receive
ALLO-501A, ALLO-647ExperimentalNot described
Receives: Genetic: ALLO-501A; Biological: ALLO-647; Drug: Fludarabine; Drug: Cyclophosphamide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Phase 1a: Proportion of subjects experiencing Dose Limiting Toxicities (DLT) at increasing doses of ALLO-501A

    Dose limiting toxicity is defined as protocol-defined ALLO-501A-related adverse events with onset within 28 days following infusion

    Measured: 28 days

  2. Phase 1a: Proportion of subjects experiencing Dose Limiting Toxicity with ALLO-647 in combination with fludarabine/cyclophosphamide administered prior to ALLO-501A

    DLT is defined as protocol-defined ALLO-647-related adverse events with onset within 33 days following 1st infusion

    Measured: 33 days

  3. Phase 1b: Frequency and severity of ALLO-501A treatment-emergent adverse events (AEs), serious AEs, and AEs of special interest

    Measured: Up to 60 months

  4. Phase 2: Overall Response Rate (ORR) assessed per Independent Review Committee (IRC)

    ORR defined as assessment of CR and PR using Lugano classification criteria 2014

    Measured: Up to 60 months

Secondary outcomes (19)

  1. Phase 1a, 1b, and 2: Duration of Response (DOR) assessed per IRC (Phase 2 only) and per investigator

    DOR is defined only for subjects who experience an objective response and is the time from the first objective response to disease progression or death, whichever comes first per (Cheson et al, 2014)

    Measured: Up to 60 months

  2. Phase 1a, 1b, and 2: Overall Response Rate (ORR) assessed per investigator

    Measured: Up to 60 months

  3. Phase 1a, 1b, and 2: Best overall response (CR, PR, SD, PD) assessed per IRC (Phase 2 only) and per investigator

    CR Complete Response, PR Partial Response, SD Stable Disease, PD Progressive Disease

    Measured: Up to 60 months

  4. Phase 1a, 1b, and 2: Progression Free Survival (PFS) assessed per IRC (Phase 2 only) and per investigator

    PFS, defined as time from the enrollment date to progression, relapse, or death

    Measured: Up to 60 months

  5. Phase 1a, 1b, and 2: Time to Response (TTR) assessed per IRC (Phase 2 only) and per investigator

    TTR, defined as the time from the enrollment date to the first observed response

    Measured: Up to 60 months

  6. Phase 1a, 1b, and 2: Overall Survival (OS)

    OS, defined as the time from the enrollment date to death

    Measured: Up to 60 months

  7. Phase 1a, 1b, and 2: Depth of lymphodepletion as assessed by lymphocyte count

    Measured: Up to 9 months

  8. Phase 1a, 1b, and 2: Duration of lymphodepletion as assessed by lymphocyte recovery

    Measured: Up to 9 months

  9. Phase 1a, 1b, and 2: Serum concentration of ALLO-647 as measured by microgram per microliter for use in a population PK model

    Measured: Up to 9 months

  10. Phase 1a, 1b, and 2: ALLO-501A expansion assessed by peak blood concentration (Cmax)

    Measured: Up to 9 months

  11. Phase 1a, 1b, and 2: ALLO-501A expansion assessed by area under the curve (AUC)

    Measured: Up to 9 months

  12. Phase 1a, 1b, and 2: ALLO-501A persistence assessed by peak blood concentration (Cmax)

    Measured: Up to 9 months

  13. Phase 1a, 1b, and 2: ALLO-501A persistence assessed by area under the curve (AUC)

    Measured: Up to 9 months

  14. Phase 1a, 1b, and 2: Pharmacodynamics will be evaluated on host T cell counts

    Measured: Up to 9 months

  15. Phase 1a, 1b, and 2: The incidence of anti-drug antibodies against ALLO-501A scFv and/or TALEN®

    Measured: Up to 9 months

  16. Phase 1a, 1b, and 2: The incidence of anti-drug antibodies against ALLO-647

    Measured: Up to 9 months

  17. Phase 1a, 1b, and 2: Adverse Events (AEs) as characterized by preferred term, frequency, severity timing, seriousness, and relationship to ALLO-501A

    The incidence and severity of Cytokine Release Syndrome (CRS), Graft-Versus-Host Disease (GVHD), infections, cytopenias, and neurotoxicity

    Measured: Up to 60 months

  18. Phase 1a, 1b, and 2: AEs as characterized by preferred term, frequency, severity, timing, seriousness, and relationship to ALLO-647

    The incidence of infusion-related reactions, cytopenias, and infections

    Measured: Up to 60 months

  19. Phase 1a, 1b, and 2: The incidence and severity of clinically significant laboratory toxicities and relationship to ALLO-647

    Measured: Up to 60 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Jun 2020
  2. Study start21 May 2020
  3. Primary completionFeb 2029 (estimated)
  4. Study completionMay 2029 (estimated)

Resources

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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
160 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04416984
Sponsor's protocol ID
ALLO-501A-201
Acronym
ALPHA2
Status last verified
Mar 2026
First submitted
29 May 2020
Last updated
4 Mar 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Locke FL, Munoz JL, Tees MT, Lekakis LJ, de Vos S, Nath R, Stevens DA, Malik SA, Shouse GP, Hamadani M, Oluwole OO, Perales MA, Miklos DB, Fisher PW, Feng A, Navale L, Le Gall JB, Neelapu SS. Allogeneic Chimeric Antigen Receptor T-Cell Products Cemacabtagene Ansegedleucel/ALLO-501 in Relapsed/Refractory Large B-Cell Lymphoma: Phase I Experience From the ALPHA2/ALPHA Clinical Studies. J Clin Oncol. 2025 May 10;43(14):1695-1705. doi: 10.1200/JCO-24-01933. Epub 2025 Feb 13.

    PubMed 39946666

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing ALLO-501A, ALLO-647 and Fludarabine in people with Relapsed or Refractory Large B Cell Lymphoma, Relapsed or Refractory Chronic Lymphocytic Leukemia, Relapsed or Refractory Small Lymphocytic Lymphoma, run by Allogene Therapeutics at 29 sites in 3 countries.

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 15 inclusion and 8 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 4 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 29 sites in United States, Australia, Canada. 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 combined 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.

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?

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?

Phase 1a: Proportion of subjects experiencing Dose Limiting Toxicities (DLT) at increasing doses of ALLO-501A (time frame: 28 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04416984, which also lists 1 linked publication.

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 Mar 2026.

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