B-cell LymphomaPERSISTNCT07474051

Long-Term Follow-Up of AvenCell Sponsored CAR-T Cell Clinical Trials

An observational study of B-cell Lymphoma and Chronic Lymphocytic Leukemia, run by AvenCell Therapeutics, Inc. at 5 sites in Germany.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts

Official record

Search all trials

Trial summary

The goal of this clinical study is to learn more about the long-term safety, effectiveness and prolonged action of patients who participated in an AvenCell-sponsored clinical trial and received treatment with AvenCell's UniCAR or RevCAR platforms. Read more about this study

Who is it for?: Any age
Conditions the study is for: B-cell Lymphoma, Chronic Lymphocytic Leukemia, Hematologic Malignancy
What is being tested?: UniCAR02-T (IMP) With Targeting Module TM123, UniCAR02-T-pPSMA and Allo-RevCAR01- T with Targeting Module R-TM123
How many people: 178 participants
Where: 5 sitesGermany
Study dates: 29 Jan 2026to 30 Jan 2041
Phase: Observational

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 Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

Study population: Participants Who Received an AvenCell CAR-T Cell Therapy

Who may be able to join

Participant who received an AVC-CAR-T cell therapy within an AVC-sponsored clinical trial.
Participant signed written informed consent for the AVC-PERSIST study.

Who cannot join

Participant is unable to provide written informed consent.
Participant is unable to comply with study requirements in the eyes of the Investigator.

Trial locations and contacts

5 sites in 1 country. Contact the study team or a site near you to ask about taking part.

City, postcode or hospital

5 sites in 1 country

Germany5 sites

Charité Universitätsmedizin Berlin
Berlin
Technische Universitaet Dresden - Universitaetsklinikum Carl Gustav Carus
Dresden
Universitätsklinikum Marburg
Marburg
Klinikum der Universität (LMU) Muenchen
Munich
Universitatsklinikum Ulm
Ulm

Other trials in Germany

About this study

Official title: Persistence Evaluation and Response Study for Immunotherapy Safety Tracking of Participants Who Receive an AvenCell CAR-T Cell Therapy

Read the detailed description

To assess the incidence and severity of delayed serious adverse events (SAEs) possibly related to AVC-CAR-T cell therapy and AEs of special interest (AESIs), including secondary malignancies, neurologic disorders, rheumatologic or other autoimmune disorders, newly diagnosed serious hematologic disorders, severe infections, as well as pregnancy and newborn health complications where observed.

Conditions: B-cell Lymphoma, Chronic Lymphocytic Leukemia, Hematologic Malignancy, AML (Acute Myelogenous Leukemia), Prostate Cancer
Being tested: UniCAR02-T (IMP) With Targeting Module TM123, UniCAR02-T-pPSMA, Allo-RevCAR01- T with Targeting Module R-TM123, Allo-QuadCAR01-T
Medical subject headings: Lymphoma, B-Cell, Leukemia, Lymphocytic, Chronic, B-Cell, Hematologic Neoplasms, Leukemia, Myeloid, Acute, Prostatic Neoplasms

What participants receive

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

UniCAR02-T (IMP) With Targeting Module TM123Biological
No investigational product will be administered
UniCAR02-T-pPSMABiological
No investigational product will be administered
Allo-RevCAR01- T with Targeting Module R-TM123Biological
No investigational product will be administered
Allo-QuadCAR01-TBiological
No investigational product will be administered

Study groups in NCT07474051
Study group	Role	What they receive
UniCAR02-T With Targeting Module TM123 (UC02-123-01)		All participants who previously received UniCAR02-T With Targeting Module TM123 in the parent study will be enrolled in this cohort for long-term follow-up. Receives: Biological: UniCAR02-T (IMP) With Targeting Module TM123
UniCAR02-T With Targeting Module TMpPSMA (UC02-PSMA-01)		All participants who previously received UniCAR02-T With Targeting Module TMpPSMA in the parent study will be enrolled in this cohort for long-term follow-up. Receives: Biological: UniCAR02-T-pPSMA
Allo-RevCAR01- T Targeting Module R-TM123 (AVC-201-01)		All participants who previously received Allo-RevCAR01- T Targeting Module R-TM123 in the parent study will be enrolled in this cohort for long-term follow-up. Receives: Biological: Allo-RevCAR01- T with Targeting Module R-TM123
Allo-QuadCAR01-T (AVC-203-01)		All participants who previously received Allo-QuadCAR01-T in the parent study will be enrolled in this cohort for long-term follow-up. Receives: Biological: Allo-QuadCAR01-T

What is being measured

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

To assess delayed adverse events including secondary malignancies which are suspected related to previous AVC-CAR-T cell therapy
- Number of participants with serious adverse events (SAEs)
- Number of participants with new malignancies or recurrence of pre-existing malignancy
- Number of participants with new incidence or exacerbation of a pre-existing neurologic disorder
- Number of participants with new incidence or exacerbation of a pre-existing rheumatologic or other autoimmune disorder
- Number of participants with new incidence of serious hematologic disorder
- Number of participants with new incidence of and/or recurring severe infection(s)
- Number of pregnancy complications and newborn health complications
Measured: Up to 15 years

Secondary outcomes (6)

Overall Survival (OS)
OS is defined as the time from Allo-QuadCAR01-T infusion to death from any cause.
Measured: Up to 15 years
Progression-Free Survival (PFS)
PFS is defined as the time from Allo-QuadCAR01-T infusion to disease progression per the Lugano Classification, as determined by investigator review or death from any cause.
Measured: Up to 15 years
Event-free survival (EFS)
EFS is defined as the time from treatment initiation to the first occurrence of disease progression, relapse, initiation of new anti-cancer therapy, or death from any cause.
Measured: Up to 15 years
Cause of death
Cause of Death is defined as the underlying disease, treatment-related toxicity, or other medical event leading directly to a participant's death, as determined by the investigator.
Measured: Up to 15 years
RCR in peripheral blood
Number of participants with measurable RCR in peripheral blood
Measured: 15 years post last treatment
Pre-existing GvHD
Number of participants with new incidence or exacerbation of a pre-existing GvHD
Measured: 15 years post last treatment

Timeline

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

29 Jan 202630 Jan 2041

First posted16 Mar 2026
Study start29 Jan 2026
Primary completion30 Nov 2040 (estimated)
Study completion30 Jan 2041 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for B-cell LymphomaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 178 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07474051
Sponsor's protocol ID: AVC-PERSIST
Other IDs: 2025-521717-67-00, 2025
Acronym: PERSIST
Status last verified: Mar 2026
First submitted: 11 Mar 2026
Last updated: 16 Mar 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Interested in taking part?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

RecruitingPhase 2
Obinutuzumab and ICE Chemotherapy in Refractory/Recurrent CD20+ Mature NHL
Non-Hodgkin Lymphoma, Burkitt Lymphoma
Active, not recruitingPhase 1/2
Selinexor Plus Combination Chemotherapy in Treating Patients With Advanced B Cell Non-Hodgkin Lymphoma
Diffuse Large B-Cell Lymphoma, Recurrent B-Cell Non-Hodgkin Lymphoma
RecruitingPhase 2
AlloSCT for Malignant and Non-malignant Hematologic Diseases Utilizing Alpha/Beta T Cell and CD19+ B Cell Depletion
Acute Leukemia, Severe Aplastic Anemia
RecruitingPhase 3
Testing Early Treatment for Patients With High-Risk Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Leukemia (SLL), EVOLVE CLL/SLL Study
Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma
RecruitingPhase 2
Acalabrutinib in Combination With Venetoclax for the Treatment of Refractory or Recurrent Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma, The AVENUE-2 Trial
Recurrent Chronic Lymphocytic Leukemia, Recurrent Small Lymphocytic Lymphoma

All B-cell Lymphoma trials