NCT03939026: ALPHA

Safety and Efficacy of ALLO-501 Anti-CD19 Allogeneic CAR T Cells in Adults With Relapsed/Refractory Large B Cell or Follicular Lymphoma

Completed Phase 1 Last updated 2 March 2026

What this trial tests

Phase 1 trial testing ALLO-501 in Relapsed/Refractory Large B Cell Lymphoma in 50 participants. Completed in 28 January 2025.

Timeline

1 May 2019

Primary endpoint
23 October 2021

28 January 2025

Quick facts

Lead sponsor	Allogene Therapeutics
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	50
Start date	1 May 2019
Primary completion	23 October 2021
Estimated completion	28 January 2025
Sites	7 locations across United States

Drugs / interventions tested

• ALLO-501
• ALLO-647 — full drug profile →
• Fludarabine (FLUDARABINE) — full drug profile →
• Cyclophosphamide (cyclophosphamide) — full drug profile →

Conditions studied

• Relapsed/Refractory Large B Cell Lymphoma — all drugs for Relapsed/Refractory Large B Cell Lymphoma →
• Relapsed/Refractory Follicular Lymphoma — all drugs for Relapsed/Refractory Follicular Lymphoma →

Sponsor

Allogene Therapeutics — full company profile →

Who can join

18 and older, any sex, with Relapsed/Refractory Large B Cell Lymphoma or Relapsed/Refractory Follicular Lymphoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The purpose of the ALPHA study is to assess the safety, efficacy, cell kinetics and immunogenicity of ALLO-501 in adults with relapsed or refractory large B-cell lymphoma or follicular lymphoma after a lymphodepletion regimen comprising fludarabine, cyclophosphamide, and ALLO-647.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Engineering strategies to overcome the current roadblocks in CAR T cell therapy.
   Rafiq S, Hackett CS, Brentjens RJ. · · 2020 · cited 1111× · PMID 31848460 · DOI 10.1038/s41571-019-0297-y
2. Trial watch: chemotherapy-induced immunogenic cell death in immuno-oncology.
   Vanmeerbeek I, Sprooten J, De Ruysscher D, Tejpar S, et al · · 2020 · cited 179× · PMID 32002302 · DOI 10.1080/2162402x.2019.1703449
3. Advances in Universal CAR-T Cell Therapy.
   Lin H, Cheng J, Mu W, Zhou J, et al · · 2021 · cited 135× · PMID 34691052 · DOI 10.3389/fimmu.2021.744823
4. New agents and regimens for diffuse large B cell lymphoma.
   Wang L, Li LR, Young KH. · · 2020 · cited 109× · PMID 33317571 · DOI 10.1186/s13045-020-01011-z
5. CAR-T cell combination therapy: the next revolution in cancer treatment.
   Al-Haideri M, Tondok SB, Safa SH, Maleki AH, et al · · 2022 · cited 106× · PMID 36419058 · DOI 10.1186/s12935-022-02778-6
6. Next generations of CAR-T cells - new therapeutic opportunities in hematology?
   Tomasik J, Jasiński M, Basak GW. · · 2022 · cited 98× · PMID 36389658 · DOI 10.3389/fimmu.2022.1034707
7. Allogeneic CAR Cell Therapy-More Than a Pipe Dream.
   Caldwell KJ, Gottschalk S, Talleur AC. · · 2020 · cited 98× · PMID 33488631 · DOI 10.3389/fimmu.2020.618427
8. Lentiviral Vectors for T Cell Engineering: Clinical Applications, Bioprocessing and Future Perspectives.
   Labbé RP, Vessillier S, Rafiq QA. · · 2021 · cited 95× · PMID 34452392 · DOI 10.3390/v13081528