Classical Hodgkin LymphomaPhase 1/2NCT06617286
CD30 CAR T-cells Post AutoHSCT for Poor-risk Hodgkin Lymphoma
A Phase 1/2 study testing CD30 CAR T-cell in people with Classical Hodgkin Lymphoma, run by New York Medical College at 1 site in United States.
Trial summary
Patients with poor risk classical Hodgkin Lymphoma (cHL) will undergo myeloablative chemotherapy (MAC) with autologous stem cell transplantation (AutoHSCT) and subsequently receive autologous CD30+ CAR T-cells. Read more about this study
- Who is it for?
- Ages 6 to 29 years
- Conditions the study is for
- Classical Hodgkin Lymphoma
- What is being tested?
- CD30 CAR T-cell
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2026to 31 Dec 2040
- 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 6 to 29 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age between ≥ 6 and ≤ 29.99 years at the time of consent.
- Lansky OR Karnofsky score of ≥ 60% (see Appendix VI)
- Disease Status: Confirmed diagnosis of CD30+ classical Hodgkin Lymphoma and meets eligibility to undergo ASCT. Must meet one of the following:
- Induction failure Progressive disease Disease relapse (1st, 2nd or 3rd)
- Confirmatory re-biopsy of relapse/refractory/persistent CD30+ cHL prior to study entry.
- Risk Factors: Patient must meet 2 or more of the established risk factors:
- Performance score (Karnofsky/Lansky) <;90% Time from diagnosis to first relapse of <1 year Extra nodal involvement at the time of relapse/progression High baseline metabolic tumor volume (MTV, >60mL) by 18F-fluorodeoxyglucose positron emission tomography (PET)/computed tomography (CT) Chemo resistant disease (Deauville 4-5) after the first re-induction
Who cannot join
- not meeting the inclusion criteria
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
New York Medical College
Valhalla, New York, 10595
Mitchell S Cairo, MD, 914-594-2150, mitchell_cairo@nymc.edu
About this study
Official title: MAC-CAR: A Phase 1B/II Trial of Myeloablative Conditioning and Autologous Stem Cell Transplantation Followed by Autologous CD30+ CAR T Cells in Children, Adolescents and Young Adults With Poor-Risk Classical Hodgkin Lymphoma (cHL)
Patients with poor risk classical Hodgkin Lymphoma (cHL) will undergo myeloablative chemotherapy (MAC) with autologous stem cell transplantation (AutoHSCT) and subsequently receive autologous CD30+ CAR T-cells.
Read the detailed description
Eligible patients will be screened for study entry and proceed to cell procurement at local sites with collection of peripheral blood mononuclear cells (PBMC) for CD30+ CAR T-cell manufacturing at UNC. Patients will then have autologous stem cells collected (PBSC) and stored for future AutoHSCT.
After another screening for MAC+AutoHSCT, patients who meet criteria will receive BEAM conditioning followed by AutoHSCT. About 21-42 day after the autologous stem cell infusion, patients will receive their autologous CD30+ CAR T-cell infusion, if they meet subsequent pre CD30+ CAR T-cell eligibility criteria.
- Conditions
- Classical Hodgkin Lymphoma
- Being tested
- CD30 CAR T-cell
- Keywords
- classical Hodgkin lymphoma, CAR T-cells
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CD30 CAR T-cellBiological
After MAC and AutoHSCT patients will receive CD30+ CAR T-cells (Phase 1B dose level 1 - 1x108/m2 (max 2.5x108) or dose level 2 - 2x108/m2 (max 5.0 x108) 21-42 days after the AutoHSCT and the RP2D dose level obtained in the Phase IB part administered in the Phase II portion.
| Study group | Role | What they receive |
|---|---|---|
| CD30 CAR T-cells | Experimental | Patients will receive autologous CD30 CAR T-cells post autologous stem cell transplant between days 21-42. Receives: Biological: CD30 CAR T-cell |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of administering CAR T-cells
To evaluate the incidence of adverse events related to autologous CD30+ CAR T-cell infusions including not limited to infusions related reactions (IRR) (CTCAE 5.0), cytokine release syndrome (CRS) (ASCTC), and Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS) (ASCTC) and all general grade 3-5 toxicities (CTCAE 5.0) in children, adolescent, and young adult patients with poor-risk CD30+ cHL following MAC AutoHSCT.
Measured: 2 years
Feasibility of Central Manufacturing of CAR T-cells
To evaluate the feasibility of local site PBMC collection and central GMP CD30 CAR T cell manufacturing with a 75% success rate in children, adolescent, and young adult patients with poor-risk CD30+ cHL following MAC AutoHSCT.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2024
- Study start1 Dec 2026 (estimated)
- Primary completion31 Dec 2039 (estimated)
- Study completion31 Dec 2040 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Classical Hodgkin 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
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (estimated)
Sponsor and investigators
- Lead sponsor
- New York Medical College
- Sponsor type
- University, hospital or other
- Collaborators
- University of North Carolina
- Responsible party
- Sponsor
- Investigators
- Mitchell S Cairo, MD, Principal investigator, New York Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06617286
- Sponsor's protocol ID
- NYMC 624
- Status last verified
- Apr 2026
- First submitted
- 9 Sep 2024
- Last updated
- 15 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MAC-CAR: A Phase 1B/II Trial of Myeloablative Conditioning and Autologous Stem Cell Transplantation Followed by Autologous CD30+ CAR T Cells in Children, Adolescents and Young Adults With Poor-Risk Classical Hodgkin Lymphoma (cHL)
- ClinicalTrials.gov ID
- NCT06617286
- Acronym / sponsor ID
- NYMC 624
- Conditions
- Classical Hodgkin Lymphoma
- Keywords
- classical Hodgkin lymphoma, CAR T-cells
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 21 participants (estimated)
- Lead sponsor
- New York Medical CollegeUniversity, hospital or other
- Collaborators
- University of North Carolina
- Study start
- 1 Dec 2026 (estimated)
- Primary completion
- 31 Dec 2039 (estimated)
- Study completion
- 31 Dec 2040 (estimated)
- First posted
- 27 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients with poor risk classical Hodgkin Lymphoma (cHL) will undergo myeloablative chemotherapy (MAC) with autologous stem cell transplantation (AutoHSCT) and subsequently receive autologous CD30+ CAR T-cells.
Detailed description
Eligible patients will be screened for study entry and proceed to cell procurement at local sites with collection of peripheral blood mononuclear cells (PBMC) for CD30+ CAR T-cell manufacturing at UNC. Patients will then have autologous stem cells collected (PBSC) and stored for future AutoHSCT.
After another screening for MAC+AutoHSCT, patients who meet criteria will receive BEAM conditioning followed by AutoHSCT. About 21-42 day after the autologous stem cell infusion, patients will receive their autologous CD30+ CAR T-cell infusion, if they meet subsequent pre CD30+ CAR T-cell eligibility criteria.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CD30 CAR T-cells | Experimental | Biological: CD30 CAR T-cellPatients will receive autologous CD30 CAR T-cells post autologous stem cell transplant between days 21-42. |
Who may qualify
- Ages
- 6 to 29 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- Age between ≥ 6 and ≤ 29.99 years at the time of consent.
- Lansky OR Karnofsky score of ≥ 60% (see Appendix VI)
- Disease Status: Confirmed diagnosis of CD30+ classical Hodgkin Lymphoma and meets eligibility to undergo ASCT. Must meet one of the following:
- Induction failure Progressive disease Disease relapse (1st, 2nd or 3rd)
- Confirmatory re-biopsy of relapse/refractory/persistent CD30+ cHL prior to study entry.
Key exclusion criteria (1 listed)
- not meeting the inclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CD30 CAR T-cellAfter MAC and AutoHSCT patients will receive CD30+ CAR T-cells (Phase 1B dose level 1 - 1x108/m2 (max 2.5x108) or dose level 2 - 2x108/m2 (max 5.0 x108) 21-42 days after the AutoHSCT and the RP2D dose level obtained in the Phase IB part administered in the Phase II portion. | Biological | CD30 CAR T-cells |
Primary outcome
Safety of administering CAR T-cells
Time frame: 2 years
To evaluate the incidence of adverse events related to autologous CD30+ CAR T-cell infusions including not limited to infusions related reactions (IRR) (CTCAE 5.0), cytokine release syndrome (CRS) (ASCTC), and Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS) (ASCTC) and all general grade 3-5 toxicities (CTCAE 5.0) in children, adolescent, and young adult patients with poor-risk CD30+ cHL following MAC AutoHSCT.
Feasibility of Central Manufacturing of CAR T-cells
Time frame: 1 year
To evaluate the feasibility of local site PBMC collection and central GMP CD30 CAR T cell manufacturing with a 75% success rate in children, adolescent, and young adult patients with poor-risk CD30+ cHL following MAC AutoHSCT.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mitchell S Cairo, MD principal investigator
New York Medical College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing CD30 CAR T-cell in people with Classical Hodgkin Lymphoma, run by New York Medical College at 1 site in United States.
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 7 inclusion and 1 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: opening soon, as of the sponsor's last update on 15 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
Contact Mitchell S Cairo, MD (914-594-2150, mitchell_cairo@nymc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of administering CAR T-cells (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Apr 2026.